Health Condition 1: null- Newly diagnosed inoperable locally advanced or metastatic infiltrating ductal adenocarcinoma of pancreas.
Conditions
Interventions
Intervention1: P276-00: P276-00 will be administered as an intravenous infusion in 200 ml 5% dextrose over 30 min from days 1 to 5 per 21 day cycle at a starting dose of 100 mg/m2/day. Subsequent dose
Sponsors
Piramal Life Sciences Limited
Eligibility
Inclusion criteria
Inclusion criteria: 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
Exclusion criteria
Exclusion criteria: 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)
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| To determine clinical benefit response to P276-00 in combination with Gemcitabine in patients with cancer of pancreas.Timepoint: At the end of study;To determine clinical benefit response to P276-00 in combination with Gemcitabine in patients with cancer of pancreas.Timepoint: At the end of study;To determine clinical benefit response to P276-00 in combination with Gemcitabine in patients with cancer of pancreas.Timepoint: At the end of study;To determine clinical benefit response to P276-00 in combination with Gemcitabine in patients with cancer of pancreas.Timepoint: At the end of study | — |
Secondary
| Measure | Time frame |
|---|---|
| To characterize toxicities of P276-00 in combination with Gemcitabine.Timepoint: At the end of study;To evaluate exploratory biomarkers associated with use of P276-00 and Gemcitabine.Timepoint: At the end of study;To evaluate pharmacokinetic parameters of P276-00.Timepoint: At the end of study | — |
Countries
India
Contacts
Public ContactDr Sanjeev C Hegde
Vice President- Clinical Research (R & D)
Outcome results
None listed