A clinical trial to study safety and effects of P276-00 in combination with Gemcitabine in treatment of pancreatic cancer .
- Conditions
- Health Condition 1: null- Newly diagnosed inoperable locally advanced or metastatic infiltrating ductal adenocarcinoma of pancreas.
- Registration Number
- CTRI/2009/091/000214
- Lead Sponsor
- Piramal Life Sciences Limited
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Completed
- Sex
- Not specified
- Target Recruitment
- 23
1. Histologically or cytologically confirmed diagnosis of infiltrating ductal adenocarcinoma of pancreas. 2. Chemonaive patients i.e. patients must not have received chemotherapy or biologic/targeted anticancer therapy for the adenocarcinoma of pancreas. 3.Locally advanced inoperable pancreatic cancer. 4. Patients of either sex, aged > or = 18 years.5. Karnofsky performance status of > or = 60%. 6. Adequate bone marrow reserve: white blood cell (WBC) count > or = 4 x 109/l, Absolute neutrophil count (ANC) > or = 1.5 x 109/l, platelets > or =100 x 109/l, hemoglobin > or = 10 g/dl.7. 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). 8. Adequate renal function: creatinine < or = 1.5 times the upper normal value.9. If female a)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. b) Negative urine beta HCG test within 1 week prior to protocol entry where childbearing potential is not terminated.10. Additional inclusion criterion only for part B: Patient should satisfy at least one of the following criteria on cycle 1 day 1:a) Karnofsky performance status of 60 or 70 b)Baseline analgesic consumption of > or = 10 morphine equivalent per day c) Baseline pain intensity score of > or = 20 mm
1. Inability / unwillingness to give consent
2. Pregnant or breast feeding women
3. Brain metastasis (active or inactive)
4. Serious concomitant systemic disorders including, but not limited to active infection, congestive heart failure, cardiac arrhythmia, psychiatric illness etc that are incompatible with the study (at the discretion of the investigator)
5.Patients known to be suffering from infection with HIV,Tuberculosis,Hepatitis C or Hepatitis B.
6. Patients who had received any other investigational drug within 1 month prior to Day 1 of protocol treatment or who have not recovered (to grade 1) from adverse effects of the investigational agent received prior to this period.
7. Patients with QTc 450 msec on 12-lead standard electrocardiogram (ECG)
8. Major surgery within 2 weeks prior to protocol
treatment
9. Radiotherapy to 10% of bone marrow
10. Patients with clinically significant 3rd space fluid
1.accumulation (ascites, pleural effusion)
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method
- Secondary Outcome Measures
Name Time Method