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Safety and Efficacy Study of P276-00 in Combination With Gemcitabine in Patients With Advanced Pancreatic Cancer

NCT00898287 · Status: COMPLETED · Phase: PHASE1/PHASE2 · Type: INTERVENTIONAL · Enrollment: 23

Last updated 2012-01-20

No results posted yet for this study

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 pancreatic cancer.

Conditions

Interventions

DRUG

P276-00

Subjects will be enrolled at different levels of P276-00 dosage as follows:- Level 1 - 100mg/ m 2/day x 5 q 3 weeks Level 2 - 140 mg/ m2/day x 5 q 3 weeks Level 3 - 185 mg/ m2 /day x 5 q 3 weeks P276-00 will be administered as intravenous infusion in 200 ml of 5% dextrose over 30min from days 1 to 5 per 21 day cycle. Six such cycles will be administered unless there is progression of disease or unacceptable toxicity.

DRUG

Gemcitabine

Gemcitabine will be administered as an intravenous infusion at dose of 1000mg/m 2 over 30 mins every week for 7 weeks followed by a gap of one week and then 3 weekly doses every 4 weeks. This treatment will be continued for six P276-00 cycles of 3 weeks each unless there is progression of disease or unacceptable toxicity.

Sponsors & Collaborators

  • Piramal Enterprises Limited

    lead INDUSTRY

Principal Investigators

  • Amol Bapaye, MS · Deenanath Mangeshkar Hospital & Research Centre, ,Pune, India

  • Raj Nagarkar, MS · Curie Manavata Cancer Centre, Nashik, India

  • J S Rajkumar, DNB · Lifeline Mutispecilaity Hospital, Chennai, India

  • Ravi K Saxena, DNB · Global Hospital, Hyderabad, India.

  • Kirushna Kumar, MD · Meenakshi Mission Hospital & Reasearch Centre, Madurai, India

  • Anita Ramesh, MD · Sri RamaChandra Medical Centre, Chennai, India

  • Ajay Mehta, MS · Central India cancer Research Institute, Nagpur, India

Study Design

Allocation
NA
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2009-05-31
Primary Completion
2010-12-31

Countries

  • India

Study Locations

More Related Trials

Entities

Drugs
Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT00898287 on ClinicalTrials.gov