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All Cancer Type / Bladder
/ Breast / Colon
/ Gastric / H&N
/
HBV Reactivation / Leukemia
/ Liver / Lung
/ Myeloma / NPC
/ Prostate / QOL
/ SYM / VAC
All Cancer Type
(ACT001) A Phase I, randomised, multi-centre, open-label
study to determine the pharmacokinetics and tolerability
of cediranib (RECENTIN™, AZD2171) following a
single and multiple oral 20mg or 30 mg doses in Chinese
patients with advanced solid malignancies
Eligibility: Provision of informed
consent. Age >= 18 years, Male or female. Histological
and/or cytological confirmed advanced solid malignancies.
Refractory to conventional therapeutic modalities,
or for which no appropriate therapies exist. WHO Performance
status < 2. Life expectancy of more than 12 weeks.
Objectives: Primary Objectives: To
assess the pharmacokinetics (PK) of single dose of
cediranib 20 mg or 30 mg. Secondary Objectives: To
assess the pharmacokinetics of multiple doses of cediranib
20mg or 30 mg in Chinese patients with advanced solid
malignant tumours. Exploratory Objectives: To assess
the safety and tolerability of single and multiple
doses of cediranib 20 mg or 30 mg in Chinese patients
with advanced solid malignancies. To assess the preliminary
anti-tumour activity
Status: Active
Chair: Prof. Brigette Ma
Bladder Cancer
(BLD001) A Phase II Study and Efficacy Study with
the VEGF Receptor Tyrosine Kinase Inhibitor GW786034
in Patients with Metastatic Urothelial Cancer
Eligibility: Histologically or cytologically
confirmed transitional cell cancer of the urothelium/bladder.
Measurable disease. Up to one prior chemotherapy regimen
for metastatic disease. Age >18 years. Life expectancy
>=12 weeks. ECOG performance status(PS) 0, 1 or
2 .
Objectives: Primary objective: To
assess the anti-tumor activity and toxicity profile
of GW786034 in patients with metastatic urothelial
cancer. Secondary objectives: To further evaluate
the pharmacokinetic of GW786034 in patients with metastatic
urothelial cancer. To evaluate pre- and post-treatment
changes in circulating endothelial cells, monocytes
and platelets and angiogenesis-related factors.
Status: Active
Chair: Dr Ho, Wing Ming
Breast Cancer
(BRE007) A phase I/II study of weekly paclitaxel,
UFT and leucovorin in patients with metastatic breast
cancer. (Sponsored by Bristol-Myers Squibb)
Eligibility: Histologically proven
breast cancer with clinical evidence of metastatic
disease, ECOG 0-2, must have measurable or evaluable
disease, prior adjuvant or neoadjuvant chemotherapy
is allowed, radiation therapy to less than 30% of
bone marrow, adequate haematological, renal and hepatic
function, must be able to take oral medication.
Objectives: To define the MTD, toxicity
profiles, response rate, duration and time to treatment
failure of this treatment regimen.
Status: Follow Up
Chair: Prof. Winnie Yeo
(BRE013) Randomized phase II study of the combination
of oral vinorelbine with capecitabine versus a sequential
regimen of oral vinorelbine and capecitabine versus
the combination of docetaxel and capecitabine in patients
with metastatic breast cancer previously treated with
anthracyclines. (Sponsor: Pierre Fabre Medicament)
Eligibility: Female with histologically
or cytologically confirmed adenocarcinoma of the breast
and documented metastatic disease. She must be HER-2
negative disease on the primary tumour or on metastatic
site, with measurable lesion and no prior chemotherapy
for metastatic disease. Patient may have received
prior radiotherapy and hormonal therapy and she must
have adequate haematological function and hepatic
functions at study entry.
Objectives: To evaluate simultaneously
the response rate of the combination of oral vinorelbine
with capecitabine, a sequential regimen of oral vinorelbine
and capecitabine, and the combination of docetaxel
and capecitabine for the first line treatment of patients
with metastatic breast cancer, after prior anthracyclines
containing (neo)-adjuvant regimen.
Status: Follow Up
Chair: Prof. Winnie Yeo
(BRE014) A Randomized, Double-blind, Multicenter,
Placebo-controlled Study of Adjuvant Lapatinib in Women
with Early-Stage ErbB2 Overexpressing Breast Cancer
Eligibility: • Histologically
or cytologically confirmed invasive breast cancer;
primary tumor must be Tx or T1-4;
• Tumors that overexpress ErbB2;
• Completed adjuvant Chemo+ RT
Objectives: Primary: To determine
whether adjuvant therapy with lapatinib will improve
disease-free survival in women with early-stage ErbB2-overexpressing
breast cancer.
Status: Follow Up
Chair: Prof. Winnie Yeo
Colon Cancer
(COL011) A randomized, open-label phase II study evaluating
the efficacy and safety of FOLFOX-4 plus cetuximab versus
UFOX plus cetuximab as first-line therapy in subjects
with metastic colorectal cancer
Eligibility:>=18
years old. Histologically confirmed adenocarcinoma
of the colon or rectum. 1st occurence of metastatic
disease (not curatively resectable)
Objectives: Primary objective: Progression-free
survival. Secondary objectives: Response rates (CR
and PR). Overall survival (OS). Safety. Quality of
Life (FACT-C, EQ-5D). Treatment impact on social daily
living and health care resource utilization.
Status: Follow Up
Chair: Prof. Brigette Ma
(COL012) Intermittent versus continuous erlotinib
with concomitant modified 'Xelox' (q3W) in first-line
treatment of metastatic colorectal cancer
Eligibility: Male
or female outpatients ages >=18 years. Be ambulatory
and have an ECOG performance status of <=2. Patients
with histological proof of adenocarcinoma of colon
or rectum with evidence of metastatic disease. At
least one unidimensionally measurable lesion with
a diameter >=20mm using conventional CT or MRI
scans or >=10mm using spiral CT scans.
Objectives: Primary objective: To
evaluate two different schedules of Erlotinib in combination
with a modified XELOX regimen in terms of response
rate. Secondary objectives: To evaluate two different
schedules of Erlotinib and modified XELOX regimen
in terms of toxicity, their duration of response and
effect on time to progression, progression-free survival
and overall survival. To determine the effect of intermittent
versus continuous Erlotinib administration on pharmacodynamic
endpoints using tumor biopsies.
Status: Active
Chair: Prof. Brigette Ma
(COL013) An Asia Pacific non-randomized, open label
Phase II study evaluating the safety and efficacy of
FOLFIRI plus cetuximab (Erbitux) or FOLFOX plus cetuximab
as first-line therapy in subjects with KRAS wild-type
metastatic Colorectal cancer (APEC)
Eligibility: Diagnosis
of histologically confirmed adenocarcinoma of the
colon or rectum. Metastatic disease. KRAS wild-type
status of tumor tissue- Tissue should also be available
for other biomarker determinations. No previous chemotherapy
for colorectal cancer except adjuvant treatment if
terminated > 6 months before the start of treatment
in this study. Radiotherapy, surgery (excluding prior
diagnostic biopsy) or any investigational drug must
be > 30 days before the start of treatment in this
study.
Objectives: Primary objective: To
assess the Best Confirmed Overall Response Rate (BCORR)
under biweekly cetuximab plus FOLFIRI or FOLFOX as
first-line treatment for KRAS wild-type mCRC. Secondary
Objectives: To determine: Progression-free survival
time. Overall survival time. Safety.
Status: Active
Chair: Prof. Brigette Ma
(COL014) A Phase 2, Randomized, Double-blind, Placebo-controlled
Study Evaluating the Safety and Efficacy of FOLFIRI
in Combination With AMG 479 or AMG 655 Versus FOLFIRI
for the Second-line Treatment of KRAS-mutant Metastatic
Colorectal
Eligibility: Histologically
confirmed adenocarcinoma of the colon or rectum in
patients with metastatic disease. Mutant-type KRAS
tumor status. No more than 1 prior 5FU/ oxaliplatin
containing regimen (e.g. FOLFOX/ Xelox +/- avastin
or tarceva study). Prior adjuvant or neo-adjuvant
chemotherapy used prior to the onset of metastatic
disease is permitted. PD while receiving at or <=
6 months after the last dose of prior with or without
anti-VEGF therapy. RECIST measurable. ECOG = 0 or
1. 18 years or older at time of consent.
Objectives: Primary objective: Progression-free
survival (PFS), Overall Survival. Objective Response
Rate (CR + PR), rates of disease control (CR + PR
+ SD), duration of response, and time to response.
Status: Active
Chair: Prof. Brigette Ma
Gastric
Cancer
(GAT006) A Phase I/II study of Paclitaxel / Carboplatin
/ RAD001 as first line therapy for advanced adenocarcinoma
of the stomach
Eligibility: Metastatic or unresectable
loco-regional adenocarcinoma of the stomach. No prior
chemotherapy for metastatic/recurrent disease, with
good performance status and adequate hematologic,
renal and hepatic function.
Objectives: To determine DLT and
establish MTD of RAD001 in combination with paclitaxel
and carboplatin in patients with advanced adenocarcinoma
of the stomach.
Status: Active
Chair: Prof. Winnie Yeo
Head & Neck
(HAN001) A phase I study of Selective Intra-arterial
High-dose Cisplatin Infusion and Accelerated Fractionation
Radiotherapy for Non-metastatic Stage III and IV Head
and Neck Squamous Cell Carcinomas
Eligibility: Patients with histologically
proven of head and neck cancer, and have treatment-naïve.
No evidence of distant metastasis. Stage III or IV
disease.
Objectives: To determiine the maximum-tolerated
dose (MTD) of IA cisplatin with accelerated fractionation
radiotherapy.
Status: Follow-up
Chair: Dr. Kwok Hung Yu
(HAN004) A Phase 2, Randomized Trial of Chemoradiation
with or without Panitumumab in Subjects with Unresected,
Locally Advanced Squamous Cell Carcinoma of the Head
and Neck
Eligibility: Histologically or cytologically
confirmed SCC of oral cavity, oropharynx, hypopharynx,
or larynx; Stage III or Stage IVa-b (M0) disease;
ECOG performance status of 0 or 1; Bidimensionally
measurable disease >= 10 mm in at least 1 dimension;
Man or woman >= 18 years of age; Hematological
function, as follows: Absolute neutrophil count (ANC)
>= 1.5 x 109/L, Platelet count >= 100 x 109/L,
Hemoglobin >= 9 g/dL; Creatinine clearance >=
50 mL/min; Hepatic function, as follows: AST <=
2 x ULN, ALT <= 2 x ULN, Total bilirubin <=
2 x ULN; Serum magnesium >= LLN; Negative pregnancy
test.
Objectives: The primary objective
of the study is to estimate, with pre-specified precision,
the difference in local regional control rate at 2
years in subjects receiving panitumumab plus chemoradiation
or chemoradiotherapy alone as first line treatment
for locally advanced squamous cell carcinoma of the
head and neck (SCCHN). This study will also evaluate
clinical benefit, including local regional control,
overall response rate, progression-free survival,
overall survival, health-related quality of life &
patient performance status of treatment arms. In addition,
the study will investigate potential biomarker development,
biochemical & genetic (optional) markers.
Status: Follow Up
Chair: Prof. Anthony Chan
(HAN005) Phase II study of TAS-106 in patients with
recurrent or metastatic head and neck cancer refractory
to platinum based chemotherapy
Eligibility:Histologically confirmed
SCC (without NPC) originating from any site in the
head and neck, or histologically confirmed NPC. Patients
with recurrent locoregional and/or distant metastatic
head and neck (SCCHN or NPC) who are not suitable
for local therapy. Eligible patients must be platinum-based
chemotherapy refractory defined as:
Progression or recurrence during or within 12 months
of receiving a platinum-based regimen as part of primary
curative treatment or for metastatic/recurrent disease.
No intervening systemic therapy allowed except biologics.
Objective evidence of disease recurrence or metastatic
disease.Age >=18 years old at study entry. Measurable
disease according to RECIST guidelines. ECOG score
of 0-2. Hemoglobin > 9.0 g/dL. Platelet count >=100,000/uL.
Absolute neutrophil count (ANC) >=1500/µL.Serum
creatinine <=1.5 mg/dL; if >1.5 mg/dL, a calculated
creatinine clearance must be equal and more than 50
mL/min. Total bilirubin <=1.5 mg/dl. AST andALT
<=2 times ULN (may be <=5 times ULN if due to
metastatic disease in the liver).
Objectives: The primary objective
is to evaluate progression-free survival of TAS-106
in patients with recurrent or metastatic head and
neck cancer (squamous cell carcinoma [SCCHN] or nasopharyngeal
carcinoma [NPC]). Antitumour activity will be measured
by measuring the rate of objective response using
the Response Evaluation Criteria in Solid Tumours
(RECIST) guidelines. Secondary Objectives include:
To evaluate the antitumor activity. To evaluate overall
survival. To further evaluate the safety profile of
TAS-106. To investigate the relationship of TAS-106
plasma level to safety and efficacy parameters.
Status: Active
Chair: Prof. Anthony Chan
(HAN006) A Phase II Study of GW 786034 (Pazopanib)
in Advanced Thyroid Cancer
Eligibility:Histologically or cytologically
confirmed differentiated, medullary or anaplastic
thyroid cancer that is now advanced or metastatic.
0-2 prior drug therapy. Objective tumor progression
in the 6 month before enrollment (indicated CT/ biomarkers).
Absence of sensitivity to therapeutic radioiodine
(differentiated only). RECIST measurable. Age >
18yrs, ECOG 0-2, usual parameters for organ functions.
Not above BP 140/90.
Objectives: The primary objective
is to establish the safety and efficacy of GW 786034
(Pazopanib) as a therapeutic in patients afflicted
with differentiated, medullary and anaplastic thyroid
cancers. Efficacy will be assessed via the primary
endpoint of the proportion of patients who incur clinical
responses based upon RECIST criteria, and the secondary
endpoint of progression free survival. Tertiary endpoints
include time to treatment failure, overall survival,
duration of response, time to subsequent therapy,
and biomarker-based measures of response and time
to progression. Correlative objective include assessment
of the impact of therapy with GW 786034 on serum/plasma
VEGF levels.
Status: Active
Chair: Prof. Brigette Ma
Leukemia
(LUK001) A Phase I Study of CCI-779 in Combination
with Imatinib Mesylate in Chronic Myelogenous Leukemia
Eligibility: Histologic confirmed
Ph+ CML or Bcr-Abl positive CML. Chronic phase (CP)
who failed imatinib. Accelerated phase (AP) +/- imatinib
treatment. Blastic phase (BP) +/- imatinib treatment.
Confirmed t(9;22) cytogenetics of FISH on bone marrow
aspirate & biopsy within 28 days prior to registration.
Age >18 years. Performance status 0-2 according
to Southwest Oncology Group (SWOG). Life expectancy
of >3 months. AP/BP are eligible whether they have
receieved and/or failed imatinib or not. Untreated
AP or BP patients. Will have imatinib 600mg daily
for at least 14 days Tolerate imatinib prior to starting
CCI-779.
Objectives: To determine: Safety
and tolerability of CCI-779 given in combination with
imatinib in patients with CML. Potential dose-limiting
toxicities of this combination regimen. Hematologic
and cytogenetic response rates.
Status: Active
Chair: Dr Kenny Lei
Liver Cancer
(HCC013) External Radiotherapy for Unresectable Hepatocellular
Carcinoma under Respiratory Gating – Phase I/II
Study
Eligibility: Histological confirmation
of hepatocellular carcinoma: or radiological diagnosis
(liver mass on CT scan) of hepatocellular carcinoma
in hepatitis B carriers with increased serum alpha-fetoprotein
(AFP)>500ng/dL. Unresectable hepatocellular carcinoma.
Patient must be equal or over 18 years of age. Patient’s
ECOG performance status must be 0-2. Total number
of liver lesions must be 3 or less.
The sum of Largest Dimension (LD) for each lesion
must be less than 10cm. No regional lymph node or
distant metastasis. Criteria for Dose Volume Histogram
(DVH) of normal liver must be fulfilled
Objectives: To determine the maximum
radiation tolerance dose (MTD) for unresectable hepatocellular
carcinoma using gated 3D conformal radiotherapy. To
determine the local control (overall response plus
stable disease) of unresectable hepatocellular carcinoma
(HCC) treated with high dose 3D conformal radiotherapy
under respiratory gating.
Status: Active
Chair: Prof Tony Mok
(HCC015) A Phase I/II Study of PXD101 in Patients
with Unresectable Hepatocellular Carcinoma (HCC) with
Pharmacokinetic and Pharmacodynamic Evaluation
Eligibility: Age>=18. Histologically
or cytologically confirmed HCC, with ECOG <=2 and
adequate haematologic, renal and hepatic function.
Objectives: To determine DLT and
establish MTD of PXD101 in patients with inoperable
HCC. To assess tumor response according to RECIST
criteria.
Status: Active
Chair: Prof Winnie Yeo
(HCC018) A Randomized 2-Arm, Open Label, Phase II
Study of BMS-582664, Administered Orally At A Dose of
800mg Daily or Doxorubicin Administered Intravenously
At a Dose of 60mg/m2 Every 3 Weeks in Patients with
Unresectable Hepatocellular Carcinoma.
Eligibility: Histologically proven
or radiological evidence of unresectable HCC with
measurable disease; male or female > 18 years old;
with adequate bone marrow, hepatic and renal function.
Patient must NOT have prior systemic therapy for HCC,
including systemic chemotherapy, biological therapy
or hormone therapy.
Objectives: To estimate the 6-month
progression free survival rate in patients with unresectable
locally advanced or metastatic hepatocellular carcinoma
(HCC) with no prior chemotherapy for HCC, treated
with 800mg QD of BMS-582664 orally or with doxorubicin
intravenously at a dose of 60mg/m2 Q3 weeks.
Status: Follow Up
Chair: Prof Winnie Yeo
(HCC019) Pharmacokinetic Study of Doxorubicin Delivered
Through Transarterial Administered of Four Different
Doxorubicin-Loaded Formulations for Hepatocellular Carcinoma
Eligibility: Histologically or cytologically
proven unresectable HCC; massive expansive tumor type
with measurable lesion on CT scan with reasonable
tumor size. Patient should also have good performance
status and acceptable liver and renal functions.
Objectives: To evaluate plasma level
of Doxorubicin in the three groups of patients treated
with Transarterial Doxorubicin delivered with four
different formulations.
Status: Active
Chair: Prof Simon Yu, Prof Winnie
Yeo
(HCC021) A Randomized Phase I / II, Multi-Center,
Open-Label Trial of PR104 and Sorafenib in Patients
with Advanced Hepatocellular Carcinoma
Eligibility: Histologically or cytologically
proven unresectable HCC. Patient is 18 years or more,
with measurable lesion on CT scan with reasonable
tumor size. Patient should also have good performance
status and acceptable liver and renal functions.
Objectives: (Phase I): Determine
the MTD of PR104 when used in combination with standard
dose Sorafenib. (Phase II): Estimate the response
rate (RR) or PR104 / Sorafenib.
Status: Active
Chair: Prof Stephen L. Chan
(HCC022) Phase I/II study of Temsirolimus (Torisel)
as Novel Therapeutic Drug for Patients with Unresectable
Hepatocellular Carcinoma (HCC) – A correlative
study with Stathmin Over-expression.
Eligibility: Histologically or cytologically
proven unresectable HCC. Patients must have measurable
disease and have one or less than one line of prior
systemic therapy for HCC. Patient should also have
adequate haematologic, renal and hepatic function.
Objectives: (Phase I): To determine
the DLT and establish MTD of Torisel. (Phase II):
To determine the progression free survival.
Status: Active
Chair: Prof Winnie Yeo
(HCC023) A Phase I/II, Open-label, Multicentre Study
to Assess the Safety & Tolerability, and Pharmacokinetics
of AZD8055 in Asian Patients with Advanced Stage Hepatocellular
Carcinoma (HCC) and with Mild or Moderate Hepatic Impairment
Eligibility: Male or Female, aged
18 or above. For dose escalation phase: (1) confirmed
HCC, defined as cytopathologically confirmed or, (2)
in cirrhotic patients, by one imaging technique (CT
scan, MRI,) showing a nodule larger than 2 cm with
contrast uptake in the arterial phase and washout
in venous or late phases or two imaging techniques
showing this radiological behaviour for nodules of
1-2 cm in diameter. For the expansion phase: HCC confirmed
as defined above but with at least one untreated target
lesion (by locoregional therapy) that can be measured
in one dimension according to RECIST. Advanced stage
or metastatic HCC, unresectable and incurable with
ablative therapy or TACE, with no standard therapy
available. Child Pugh Liver function status classified
as A and B. WHO Performance Status 0-2.
Objectives: Primary: Assess safety
and tolerability (including MTD in CP A and B, separately).
Secondary: Determine PK parameters for AZD8055 &
metabolites. Evaluate role of renal excretion of AZD8055.
Evaluate phosphorylation levels of biomarkers [eg.
pAKT (TORC2). Provide preliminary information on antitumour
activities (RECIST). Evaluate biochemical response
(AFP). Evaluate hepatitis virus replication. Evaluate
potential immunosuppression. Investigate possible
relationships between plasma AZD8055 exposure and
liver impairment.
Status: Active
Chair: Prof Brigette Ma
Lung Cancer
(LUN024): A randomised, placebo-controlled, double-blind
phase II study of sequential administration of Tarceva®
(erlotinib) or placebo in combination with gemcitabine/platinum
as first-line treatment in patients with stage IIIB/IV
non-small cell lung cancer (NSCLC) (Sponsored by Roche)
Eligibility: Histological proven
locally advanced or metastatic NSCLC patients with
age >=18 years and had no prior chemotherapy for
advanced disease.
Objectives: Non progression rate
(CR+PR+SD). Objective response rate (CR+PR). Duration
of response. TTP. Progression free survival. Overall
survival.
Status: Follow Up
Chair: Prof. Tony Mok
(LUN029): A phase 2, multicenter, open label, randomized
trial of AMG 706 or Bevacizumab in combination with
paclitaxel and carboplatin for advanced non-squamous
non-small cell lung cancer (Sponsored by AMGEN Inc.)
Eligibility: Patients with age >=18
years. Histological confirmed advanced non-squamous
NSCLC had no prior palliative chemotherapy.
Objectives: To estimate the difference
in objective response rates between each paclitaxel/carboplatin
plus AMG 706 arm (Arm A and B) and the paclitaxel/carboplatin
plus bevacizumab arm (arm C) in subjects with advanced
non-squamous NSCLC. To estimate the duration of response,
PFS, and OS in each of the 3 treatment arms. To evaluate
the safety and tolerability in the 3 treatment arms.
To evaluate the pharmacokinetics of AMG 706 when administered
with paclitaxel and carbolpatin in Arm A and B.
Status: Follow Up
Chair: Prof. Tony Mok
(LUN034): A Phase II Study of Stereotactic Body Radiation
Therapy (SBRT) under active breathing control for primary
lung cancer and lung metastases
Eligibility: Eligible patients with
lung tumours of size 5cm or less will receive SBRT
under ABC. Age >= 18. ECOG performance status 0-2.
Life expectancy > 6 months. No prior RT to the
chest. For female, no pregnancy or lactation. No chemotherapy
or targeted therapy within 4 weeks before commencement
of RT or to be given concomitantly with RT. Adequate
lung function: SaO2 at room air >= 90% and FEV1.0
>=700ml.
Objectives: Primary: To determine
the local disease control rate at one year after SBRT.
Secondary: To observe the local disease control rate
at two year and overall survival of patients. To evaluate
the acute and late adverse effects of the treatment.
To assess the intra-fractional and inter-fractional
reproducibility of tumour position of the ABC device.
Status: Active
Chair: Dr. WK Tsang
(LUN035): A Multinational, randomized, double-blinded
study comparing Aflibercept vs placebo in patients treated
with 2nd line docetaxel for locally advanced or metastatic
Non-Small Cell Lung Cancer
Eligibility: Inclusion criteria:
Non-squamous histology/cytology. Disease progression
during or after one, and only one, prior anticancer
therapy which is platinum-based for advanced or metastatic
NSCLC. ECOG performance status 0-2. Exclusion criteria:
History of brain met., uncontrolled spinal cord compression,
or carcinomatous meningitis. Prior Docetaxel treatment.
Patient refractory to 1st line paclitaxel-based therapy.
Urine protein: creatinine ratio > 1 on morning
spot urine or proteinuria > 500 mg/24h. Uncontrolled
hypertension.
Evidence of clinically significant bleeding.
Objectives: Primary : To determine
overall survival improvement for aflibercept + docetaxel
compared to docetaxel + placebo as second line treatment
for patients with locally advanced or metastatic NSCLC.
Secondary: To compare efficacy of aflibercept to placebo
for Progression free survival, Response rate , HRQL
assessed by LCSS questionnaire. To assess the overall
safety of the two treatment arms. To assess the pharmacokinetics
of IV aflibercept on this patient population. To determine
immunogenicity of IV aflibercept in all patients.
Status: Active
Chair: Prof. Tony Mok
(LUN036) Phase IIb/III randomized. Double-blind trial
of BIBW2992 plus best supportive care (BSC) versus placebo
plus BSC in NSCLC patients failed erlotinib or gefitinib
Eligibility: Inclusion criteria:
Patient with pathologic confirmation of NSCLC stage
III-B/IV adenocarcinoma who have failed at least one
but not more than two lines of cytotoxic chemotherapy.
One of the chemotherapy regimens must have been platinum-based.
Progressive disease following at least 12 weeks of
treatment with erlotinib or gefitinib. ECOG performance
status 0-2. Exclusion criteria: Active brain metastases.
History of clinically significant or uncontrolled
cardiac disease. Known HIV, active hepatitis B or
active hepatitis C. Resting ejection of less than
50%. Significant or recent GI disorders with diarrhea
as a major symptom.
Objectives: Primary Endpoint: Overall
survival. Secondary Endpoints: Progression-free survival
time. Objective response rate. Duration of clinical
benefit. Time to objective response. Safety of BIBW2992
as indicated by intensity and incidence of adverse
events. Pharmacokinetics of BIBW2992. Health-related
quality of life.
Status: Active
Chair: Prof. Tony Mok
(LUN037) A Randomized Phase 2 Study Comparing Erlotinib
– Pemetrexed, Pemetrexed alone, and Erlotinib
alone, as Second-Line Treatment for Non-Smoker Patients
with Locally Advanced or Metastatic Nonsquamous Non-Small
Cell Lung Cancer
Eligibility: Inclusion criteria:
Histological or cytological diagnosis of NSCLC which
is locally advanced or metastatic (Stage IIIA, IIIB
or IV) NSCLC that is non squamous. Non smokers (having
smoked < 100 cigarettes or equivalent in his /
her lifetime). Must have failed only one prior chemotherapy
regimen and must be considered eligible for further
chemo following disease progression. Chemo must be
completed at least 2 weeks prior to randomization.
Objectives: Primary Endpoint: To
compare erlotinib-pemetrexed combination with pemetrexed
alone, and erlotinib alone, in terms of progression
free survival (PFS) in non smoker locally advanced
/ metastatic (stage IIIA, IIIB, or IV) non squamous
NSCLC who have failed first line chemotherapy.Secondary
Endpoints: To compare Erlotinib – Pemetrexed
combination with either agent alone for Tumor response
rate. Disease control rate (% of randomized patients
with best response of stable disease, partial response,
complete response). Overall survival (including 1year
survival rates). Safety and adverse event profile.
Association between EGFR and MTAP genotype, and clinical
outcome treatment. Time to worsening of symptoms using
the Lung Cancer Symptom Scale (LCSS).
Status: Active
Chair: Prof. Tony Mok
(LUN039) A randomized, multicenter phase II study
to explore whether biomarkers correlate with treatment
outcome in chemo-naive patients with advanced or recurrent
non-squamous NSCLC, who received treatment with bevacizumab
(at a dose of either 7.5mg /kg or 15 mg/kg) in addition
to carboplatin-based chemotherapy (gemcitabine or paclitaxel)
Eligibility: Inclusion criteria:
Histologically or cytologically documented inoperable,
locally advanced (stage IIIb with supraclavicular
lymph node metastases or malignant pleural or pericardial
effusion), metastatic (stage IV) or recurrent non-squamous
NSCLC. At least one measurable tumor lesion according
to the RECIST criteria. No prior chemotherapy or treatment
with another systemic anti-cancer agent. No history
of >= grade 2 hemoptysis (bright red blood of at
least 2.5 mL). No evidence of tumor invading or abutting
major blood vessels. No history of peripheral sensory
neuropathy of Grade 2 or more. Non healing wound,
ulcer (including peptic ulcer) or bone fracture.
Objectives: Primary Endpoint: Explore
the correlation of biomarkers with response rate as
assessed by the investigator (according to RECIST
criteria) in patients treated with carboplatin based
chemotherapy in combination with 7.5 mg/kg or 15 mg/kg
of bevacizumab. Secondary Endpoint: To evaluate progression
free survival in patients treated with carboplatin
based chemotherapy in combination with 7.5 mg/kg or
15 mg/kg of bevacizumab.To evaluate response rate,
disease control rate and duration of response (RECIST)
in patients treated with carboplatin based chemotherapy
in combination with 7.5 mg/kg or 15 mg/kg of bevacizumab.
To evaluate overall survival in patients treated with
carboplatin based chemotherapy in combination with
7.5 mg/kg or 15 mg/kg of bevacizumab. To evaluate
and assess the safety profile in patients treated
with carboplatin based chemotherapy in combination
with 7.5 mg/kg or 15 mg/kg of bevacizumab.
Status: Active
Chair: Prof. Tony Mok
(LUN040) A Phase 2, Open Label, Trial of PF-00299804
In Untreated Advanced Adenocarcinoma of the Lung in
Never or Former Light Smokers
Eligibility: Inclusion criteria:
Histologically confirmed, advanced NSCLC (Stage IIIB-IV),
adenocarcinoma subtype. No prior treatment with systemic
chemotherapy for advanced disease. Patients must be
non-smokers or light smokers. ECOG 0-1 performance
status. Brain metastasis allowed if any necessary
treatment has been completed and the patient is radiologically
and neurologically stable off corticosteroids at least
2 weeks prior to randomization.
Objectives: Primary endpoint: PFS
at 4 months. Secondary endpoint: BOR per RECIST. Duration
of response. Overall survival. PFS. Overall safety
profile. Patient reported outcome. trough concentration
of PF 00299804 in blood after repeated dosing and
in biofluid as available.
Status: Active
Chair: Prof. Tony Mok
(LUN043) A Randomized Phase 2 Trial of PF-00299804
Versus Erlotinib for the Treatment of Advanced Non-Small
Cell Lung Cancer After Failure of At least one prior
Chemotherapy Regimen
Eligibility: Provision of a personally
signed and dated voluntary written informed consent
document. Age >=18 years, male or female. Evidence
of histologically confirmed, advanced NSCLC; a. For
the purpose of randomization/ stratification the histologic
subtype of NSCLC must be available; b. The diagnosis
of NSCLC NOS (not otherwise specified) will not by
sufficient for enrollment and randomization/stratification.
ECOG 0-2 performance status. Evidence of progressive
disease after at least one and no more than two prior
chemotherapy regimens for advanced disease; patients
who completed prior adjuvant or combined modality
therapy for regional disease within 12 months may
be enrolled if they have received only one chemotherapy
regimen for advanced disease. Any prior treatment
(chemotherapy, radiation or surgery) must have been
completed at least 2 weeks prior to randomization.
Any acute toxicity must have been recovered to Grade
1 (per NCI CTCAE v3.0.1) or baseline. Measurable disease
by RECIST criteria.
Objectives: Primary: Assess the safety
and efficacy of PF-00299804 administrated as treatment
to patients with advanced NSCLC after failure of treatment
with at least one prior chemotherapy regimen.
Status: Active
Chair: Prof. Tony Mok
Myeloma
(MYE001)A Phase II Trial of Sunitinib (SU11248) in
Multiple Myeloma
Eligibility: Relapsed multiple myeloma.Measurable
disease as defined by at least ONE of the following:
Serum monoclonal protein >=1.0 g by protein electrophoresis.
>200 mg of monoclonal protein in the urine on 24
hour electrophoresis. Serum immunoglobulin free light
chain >=10 mg/dL AND abnormal serum immunoglobulin
kappa to lambda free light chain ratio. Monoclonal
bone marrow plasmacytosis >=30% (evaluable disease).
<=2 prior therapies. Stem cell transplantation
and preceding induction therapy will be considered
as one therapy. Patients must not be candidates for
stem cell transplantation or should have had stem
cells collected previously. >= 18 years of age.
Life expectancy of >= 3 months. ECOG performance
status of 0, 1 or 2.
Objectives: Primary objective: To
assess the response rate of single agent Sunitinib
in patients with relapsed multiple myeloma. Secondary
objectives: To assess the toxicity of single agent
Sunitinib in patients with relapsed multiple myeloma.
To assess time to progression after initial response
to Sunitinib. To assess the anti-angiogenic activity
of Sunitinib in Myeloma.
Status: Follow Up
Chair: Prof. Anthony Chan
Nasopharyngeal Carcinoma
(NPC008) A randomized phase II study of concurrent
cisplatin-radiotherapy with or without neoadjuvant chemotherapy
using taxotere and cisplatin in advanced nasopharyngeal
carcinoma(NPC)
Eligibility: Patients with histologically
proven of NPC, and have treatment-naïve NPC.
No evidence of distant metastasis. Stage T3-4 any
N, or any Stage T, N2-3.
Objectives: To assess and compare
the toxicities of patients with advanced NPC treated
with concurrent cisplatin-RT with or without neoadjvant
taxotere and cisplatin
Status: Follow-up
Chair: Prof. ATC Chan, Dr. P Teo
(NPC016) A Phase II Study of Concurrent Cetuximab-Cisplatin
and Radiotherapy in the Treatment of Advanced Nasopharyngeal
Carcinoma.
Eligibility: Patients with previously
untreated, histologically confirmed NPC with: ‘T3
or T4, and any N, M0’, or ‘any T and N2
or N3, M0’. No evidence of distant metastases
after staging investigations. Measurable disease must
be present. Eastern Cooperative Oncology Group (ECOG)
performance status of grade 0 or 1. Adequate bone
marrow and organ reserve: absolute neutrophil count
>= 1,500/mm3; platelets >= 100,000/mm3; hemoglobin
> 8.0 g/dl; bilirubin <= 1.5 x the upper limit
of normal (ULN); serum creatinine <= 1.2 x ULN
and a calculated creatinine clearance of >= 50ml/min);
alanine aminotransferase <= 3 x ULN. At least 18
years of age, of either sex.
Objectives: To determine the safety
and feasibility of concurrent weekly cetuximab, low-dose
cisplatin and radiotherapy (RT) in the treatment of
patients with advanced NPC. To estimate the locoregional
control rate at 3 months, progression-free survival
and overall survival rates at 1 and 3 years, and overall
disease-free survival and overall survival time. To
examine the correlation between expression levels
of the EGFR ligand TGF? and downstream signaling proteins
(pMAPK, pAKT, Stat-3), EGFR gene amplification EGFR
(intron 1) polymorphisms with treatment outcome.
Status: Follow Up
Chair:Prof. Brigette BY Ma
(NPC019) Phase 2 Study Of SU011248 In Patients With
Recurrent Or Metastatic Nasopharyngeal Carcinoma
Eligibility: Historically confirmed
diagnosis of nasopharyngeal carcinoma (NPC)(either
at initial diagnosis or at recurrence). Patients with
recurrent or metastatic NPC that has progressed following
one line of prior platinum-based chemotherapy. Disease
must be not amenable to potentially curative radiotherapy
or surgery. Measurable disease according to RECIST.
Age 18 or above; ECOG performance 0 or 1. Adequate
bone marrow, renal and hepatic reserve.
Objectives: To evaluate the efficacy
(clinical benefit rate) of single-agent SU011248 in
patients with recurrent or metastatic nasopharyngeal
carcinoma, and its impact on disease progression.
To assess objective response rate. To assess duration
of response. To assess progression-free survival and
overall survival. To evaluate the safety and tolerability
of SU011248. To evaluate SU011248 and SU012662 trough
concentrations (Ctrough) and to correlate these plasma
concentrations with efficacy and safety parameters.
To study blood and tissue biomarkers and correlate
with cancer-and treatment-related outcomes. To evaluate
early anti-angiogenic activity of SU011248 on vivo
as detected by dynamic contrast enhanced MRI.
Status: Active
Chair:Prof. Anthony Chan
(NPC020) A Phase II Study of Concurrent Chemoradiotherapy
Using Three-Dimensional Conformal Radiotherapy (3D-CRT)
or Intensity-Modulated Radiation Therapy (IMRT) + Bevacizumab
(BV) for Locally or Regionally Advanced Nasopharyngeal
Cancer (RTOG-0615)
Eligibility: Biopsy proven (from
primary lesion and/or lymph nodes) diagnosis of Stage
IIB-IVB (AJCC, 6th ed.) non-metastatic cancer of the
nasopharynx; Histologic types WHO I-IIb/III; Zubrod
Performance Status 0-1; Age >= 18; adequate bone marrow
function defined as follows: WBC >= 4,000/cmm; Absolute
neutrophil count (ANC) >= 1,500/ mm3; Platelets >=
100,000 cells/ mm3; Hemoglobin >= 9.0 g/dl. Adequate
renal function defined as serum creatinine <= 1.5
mg/dl or calculated creatinine clearance >= 55 ml/min;
adequate hepatic function defined as follows: total
bilirubin <= 1.5 X UNL; aspartate aminotransferase
<= 1.5 X UNL; alanine aminotransferase <= 1.5 X UNL;
alkaline phosphatase <= 1.5 X UNL. International normalized
ratio (INR) <= 1.5 X UNL and activated partial thromboplastin
time (aPTT) <= 1.5 X UNL within 2 weeks prior to registration.
Per the investigator’s assessment, the patient
must have the nutritional and physical condition considered
to be compatible with the proposed treatment regimen.
Objectives: To evaluate the safety
and tolerability of bevacizumab (BV) plus chemoradiation.
To determine the one- and two-year rates of local-regional
progression, distant metastases, second primary tumors,
progression-free survival, and overall survival for
stage IIB-IVB nasopharyngeal cancer, WHO types I-IIb/III
treated with 3D-CRT or IMRT concurrent with cisplatin
(CDDP) and BV, followed by adjuvant CDDP plus 5-fluorouracil
plus BV.
Status: Follow Up
Chair:Prof. Anthony Chan
(NPC021) A Phase I Trial of 5Azacitidine and Suberoylanilide
hydroxamic acid in Patients with Metastatic or Locally
Recurrent Nasopharyngeal Carcinoma and Nasal NK-T cell
Lymphoma
Eligibility: Biopsy proven nasopharyngeal
carcinoma (WHO type 3) or extranodal NK-T cell non-Hodgkin’s
lymphoma, nasal type; Patients must have metastatic
disease or locally recurrent disease that is not amendable
to surgical resection or further treatment with radiotherapy
with curative intent; Patients must have metastatic
disease or locally recurrent disease that has been
treated with at least one regimen of chemotherapeutic
agents after relapse; Patients must have disease that
is accessible to biopsy via fine needle aspiration;
Age >= 21 years; ECOG performance status <=2
(Karnofsky >=60%); Life expectancy greater than
6 months; Patients must agree to tumor biopsy to be
carried out within 72 hours of the conclusion of the
SAHA administration.
Objectives: Define toxicity profile
of escalating doses of Suberoylanilide hydroxamic
acid (SAHA) given in conjunction with a fixed dose
of 5 Azacytidine (5AC) in patients with locally recurrent
and metastatic nasopharyngeal carcinoma and NK-T cell
Nasal Lymphoma; Define the biologically optimal dose
of SAHA given in conjunction with a fixed dose of
5AC in patients with locally recurrent and metastatic
nasopharyngeal carcinoma and NK-T cell Nasal Lymphoma
based on evidence of EBV lytic induction in tumor
biopsies and plasma; Study the effect of 5AC on the
pharmacokinetic of SAHA
Status: Active
Chair:Prof. Anthony Chan
Prostate
(PST001): A Phase 2 Study of Fenretinide In Patients
With Hormone Refractory Prostate Cancer (NCI Study)
Eligibility: Histological proven
of prostate cancer with age >= 18 years and have
not received prior chemotherapy.
Objectives: To evaluate the activity
of Fenretinide in patients with advanced or metastatic
hormone refractory prostate cancer (HRPC) by estimating
the prostate specific antigen (PSA) response rate.
To estimate the duration of PSA response, PSA-progression-free
survival, overall survival, the toxicity of fenretinide
in men with prostate cancer
Status: Follow Up
Chair: Prof. Tony Mok
Symptom Control Study
(SYM007) A Randomized phase II study comparing acupuncture
to acupuncture with moxibustion on reduction of chemotherapy-induced
neutropenia
Eligibility:Aged above 18. Histological
confirmed breast cancer stage I to IIb. ECOG performance
status 0,1. Patient must receive adriamycin and cyclophosphamide
as standard adjuvant chemotherapy for breast cancer.
No prior exposure to cytotoxic chemotherapy. Life
expectancy of at least 12 months. Adequate hematological
function at enrolment: ANC > 1.5 X 109/l; platelet
> 100 X 109/l. Adequate hepatic funciton: total
bilirubin <2 upper normal limit (UNL); ALT <
3.0 UNL. Patient must be mentally competent to understand
the diagnosis and treatment plan, and agrees to sign
the informed consent.
Objectives: Primary objective: To
study the role of acupuncture on reduction of chemotherapy
induced neutropenia and febrile neutropenia in patients
with early stage breast cancer.
Status: Active
Chair: Prof. Tony Mok
Tumour Vaccine
(VAC002) A Phase I, Dose Escalation Trial of Recombinant
Modified Vaccinia Andara (MVA)-based Vaccine Encoding
Epstein-Barr Virus Target Antigens
Eligibility: Histologically confirmed
NPC, in which the presence of EBV within the malignant
cells has been demonstrated by (1) EBER (EBV early
RNA) in situ hybridisation in more than 50% of the
malignant cells, or (2) undifferentiated or poorly
differentiated carcinoma histology in association
with a raised serum titer of IgA to EBV VCA. Patients
in remission from disease, ie complete response (CR)
or unconfirmed complete response (CRu). Completion
of standard therapy for malignancy at least 12 weeks
before trial entry. Age greater than 18 years. World
Health Organisation (WHO) performance status of 0
or 1. Life expectancy of at least 4 months. Haematological
and biochemical indices: Haemoglobin (Hb) > 10.0
g/dl; Lymphocytes >= 1.0 x 109/L; Neutrophils >=
1.5 x 109/L; Platelets (Plts) >= 100 x 109/L; Serum
bilirubin <= 1.5 x upper normal limit; Serum alkaline
phosphatase, ALT and/or AST <= 1.5 x ULN; calculated
creatinine clearance >= 50ml/min
Objectives: To determine safety and
to characterise the toxicity profile of MVA-EBNA1/LMP2
vaccine. To describe changes in the frequency of functional
T-cell responses to MHC class I and II-restricted
epitopes within EBNA1 and LMP2 in peripheral blood
at sequential time-points before, during and up to
nine months after the vaccination course. To assess
changes in levels of EBV genome levels in plasma.
Status: Follow Up
Chair: Prof. Anthony Chan
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