A Phase Ib/IIa, Multicentre, Randomised, Double-blind, Parallel-group, Placebo-controlled Study to Evaluate the Safety and Pharmacokinetics of Z-360 in Subjects with Unresectable Advanced Pancreatic Cancer in Combination with Gemcitabine Treatment
- Conditions
- Pancreatic cancer
- Registration Number
- EUCTR2005-001659-39-GB
- Lead Sponsor
- ZERIA Pharmaceutical Co., Ltd.
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- ot Recruiting
- Sex
- Not specified
- Target Recruitment
- 30
• Age 20 to 70 years.
• Provide written informed consent.
• In the investigator’s opinion, the subject has the ability to co-operate with the
treatment and follow up procedures.
• Subjects with unresectable locally advanced (histologically/cytologically verified) or
metastatic pancreatic cancer.
• Subjects must have at least one measurable lesion.
• No other primary neoplasms apart from pancreatic cancer.
• Life expectancy of at least 3 months.
• Karnofsky Performance Status of =70%.
• Adequate liver and renal function as defined by: serum creatinine (=133 µmol/L);
total bilirubin levels (=34.2 µmol/L); AST or ALT levels =3 times the upper limit of
the reference range (or <5 times in the presence of liver metastases).
• Adequate bone marrow function defined by a white blood cell (WBC) count of
=3.5 x 109/L, an absolute neutrophil (ANC) count of =1.5 x 109/L, a platelet count
of =100 x 109/L and a haemoglobin level of =9.5 g/dL.
Are the trial subjects under 18? no
Number of subjects for this age range:
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range
• Pregnant or lactating women. Female subjects of child-bearing potential are
eligible, provided they have a negative urine pregnancy test prior to enrolment and
agree to use medically approved contraceptive precautions for 4 weeks prior to
entering the study and for 6 months afterwards. Male subjects must agree to use
barrier contraception during the trial and for 6 months afterwards or be surgically
sterile.
• Concurrent serious infections (ie requiring an intravenous antibiotic).
• An unstable or concurrent serious medical condition. Examples include, but are not
limited to, uncontrolled ventricular arrhythmia, recent (within 3 months) myocardial
infarction, uncontrolled major seizure disorder, superior vena cava syndrome, or any
psychiatric disorder that prohibits obtaining informed consent.
• Major surgery within the past 14 days.
• Participation in any other clinical study within the previous 30 days or during the
course of this study.
• Any contraindications to the administration of gemcitabine.
• Received previous chemotherapy for the current indication.
• Received previous radiotherapy for the current indication.
(ie if the irradiated area was the only source of measurable or assessable disease).
• Currently receiving chemotherapy.
• Currently receiving treatment with a PPI.
Study & Design
- Study Type
- Interventional clinical trial of medicinal product
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method <br> Main Objective: 1. To evaluate the safety of two doses of Z-360 with gemcitabine administration for subjects with unresectable advanced pancreatic cancer in order to determine the optimal dosage for Phase II study.<br> 2. To determine the pharmacokinetic parameters of Z-360 in subjects with pancreatic cancer.<br> ;<br> Secondary Objective: 1. To evaluate the drug-drug interaction between Z-360 and gemcitabine.<br> 2. To evaluate the efficacy of Z-360 by the objective tumour response rate.<br> 3. To evaluate the effect of Z-360 on subject quality of life as measured by a<br> quality of life questionnaire.<br> ;Primary end point(s): Completion of the 12-week treatment and 4-week follow up period.
- Secondary Outcome Measures
Name Time Method