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

NCT01272791 · Status: COMPLETED · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 70

Last updated 2017-04-19

No results posted yet for this study

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.

Conditions

Interventions

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

Sponsors & Collaborators

  • Peregrine Pharmaceuticals

    lead INDUSTRY

Principal Investigators

  • Thomas Sklenar · Peregrine Pharmaceuticals

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2011-01-31
Primary Completion
2013-02-28
Completion
2013-03-31

Countries

  • United States
  • Ukraine

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 NCT01272791 on ClinicalTrials.gov