NCT01272791

Trial of Gemcitabine With or Without Bavituximab in Patients With Previously Untreated Stage IV Pancreatic Cancer

A Randomized, Open-Label, Phase 2 Trial of Gemcitabine With or Without Bavituximab in Patients With Previously Untreated Stage IV Pancreatic Cancer

• Status: Completed
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 70 (actual)
• Sponsor: Peregrine Pharmaceuticals · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

The primary objective of this study is to compare the overall survival of patients with stage IV pancreatic cancer treated with gemcitabine alone or gemcitabine with bavituximab.

Detailed description

This is prospective, randomized, open-label, multicenter, phase 2 study of gemcitabine with or without bavituximab in patients with previously untreated stage IV pancreatic cancer.

Conditions

• Metastatic Pancreatic Cancer

Interventions

Type	Name	Description
BIOLOGICAL	bavituximab	Patients who qualify for enrollment into the study will be randomized in a 1:1 ratio to receive study treatment of gemcitabine alone or gemcitabine with weekly 3 mg/kg bavituximab. Treatment for each patient will begin on Study Day 1. Gemcitabine (1000 mg/m2) will be given on Days 1, 8 and 15 of each 28 day cycle (4 weeks) until disease progression or unacceptable toxicities. Patients randomized to receive bavituximab will be treated weekly beginning on Day 1 of each cycle. Study visits are scheduled to occur every 7 (± 2) days for bavituximab administration (for patients randomized to receive bavituximab); gemcitabine administration will occur every 7 (± 2) days for the first 3 weeks of each 4-week cycle
DRUG	Gemcitabine	Gemcitabine (1000 mg/m2) will be given on Days 1, 8 and 15 of each 28 day cycle (4 weeks) until disease progression or unacceptable toxicities

Timeline

• Start date: 2011-01-01
• Primary completion: 2013-02-01
• Completion: 2013-03-01
• First posted: 2011-01-10
• Last updated: 2017-04-19

Locations

19 sites across 2 countries: United States, Ukraine