Status:
COMPLETED
Safety and Efficacy Study of P276-00 in Combination With Gemcitabine in Patients With Advanced Pancreatic Cancer
Lead Sponsor:
Piramal Enterprises Limited
Conditions:
Pancreatic Cancer
Eligibility:
All Genders
18+ years
Phase:
PHASE1
PHASE2
Brief Summary
The purpose of this study is to identify a dose of P276-00 that can be safely administered along with Gemcitabine and to examine safety and efficacy of the combination in treatment of advanced pancrea...
Detailed Description
This study is an open label multicenter trial to evaluate safety and efficacy of P276-00 in combination with Gemcitabine in subjects with locally advanced or metastatic pancreatic cancer. Primary obje...
Eligibility Criteria
Inclusion
- Histologically or cytologically confirmed diagnosis of infiltrating ductal adenocarcinoma of pancreas.
- Chemonaive patients i.e. patients must not have received chemotherapy or biologic/targeted anticancer therapy for the adenocarcinoma of pancreas.
- Locally advanced inoperable pancreatic cancer.
- Patients of either sex, aged \> or = 18 years.
- Karnofsky performance status of \> or = 60%.
- Adequate bone marrow reserve: white blood cell (WBC) count \> or = 4 x 109/l, Absolute neutrophil count (ANC) ≥ 1.5 x 109/l, platelets \> or = 100 x 109/l, hemoglobin \> or = 10 g/dl.
- Adequate liver function: bilirubin \< or = 1.5 times the upper normal value, ALT/AST/ alkaline phosphatase less than 3 times the upper normal value (unless due to liver metastases in which case bilirubin less than 3 times the upper normal value, ALT/AST less than 4 times the upper normal value, and alkaline phosphatase without limit).
- Adequate renal function: creatinine ≤ 1.5 times the upper normal value.
- If female:
- Childbearing potential either terminated by surgery, radiation, or menopause, or attenuated by use of at least 2 approved contraceptive methods (at least one should be a barrier method) during and for 4 weeks after stopping the study treatment.
- Negative urine β-HCG test within 1 week prior to protocol entry where childbearing potential is not terminated.
- Additional inclusion criterion only for part B: Patient should satisfy at least one of the following criteria on cycle 1 day 1:
- Karnofsky performance status of 60 or 70
- Baseline pain intensity score of \> or = 20 mm
Exclusion
- Inability / unwillingness to give consent.
- Pregnant or breast feeding women.
- Brain metastasis (active or inactive).
- Serious concomitant systemic disorders incompatible with the study (at the discretion of the investigator).
- Patients known to be suffering from infection with HIV, Hepatitis C or Hepatitis B.
- Patients who had received any other investigational drug within 1 month prior to Day 1 of protocol treatment.
- Patients with QTc \> 450 msec on 12-lead standard electrocardiogram (ECG).
- Major surgery within 2 weeks prior to protocol treatment.
- Radiotherapy to \> 10% of bone marrow.
- Patients with 3rd space fluid accumulation (ascites, pleural effusion).
Key Trial Info
Start Date :
May 1 2009
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
Estimated Enrollment :
23 Patients enrolled
Trial Details
Trial ID
NCT00898287
Start Date
May 1 2009
Last Update
January 20 2012
Active Locations (7)
Enter a location and click search to find clinical trials sorted by distance.
1
Central India Cancer Research Institute
Nagpur, Ajayonco@hotmail.com, India, 440 010
2
Global Hospital
Hyderabaad, Andhra Pradesh, India, 500004
3
Curie Manavata Cancer Centre
Nashik, Maharashtra, India, 422 004
4
Deenanath Mangeshkar Hospital & Research Centre
Pune, Maharashtra, India, 411004