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A Study to Evaluate the Efficacy and Safety of Simtuzumab Combined With Gemcitabine for Metastatic Pancreatic Adenocarcinoma

NCT01472198 · Status: COMPLETED · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 250

Last updated 2015-03-10

No results posted yet for this study

Summary

This study will compare the efficacy of simtuzumab (GS-6624) versus placebo in combination with gemcitabine in adults with pancreatic cancer. The treatment phase of this study will be comprised of 2 sequential parts: an open label treatment phase and a double-blinded treatment phase.

Conditions

Interventions

DRUG

Simtuzumab

Simtuzumab administered intravenously every 2 weeks for a total of 2 infusions (Days 1 and 15)

DRUG

Gemcitabine

Gemcitabine 1000 mg/m\^2 administered intravenously on Days 1, 8, and 15 of each 28-day cycle

DRUG

Placebo to match simtuzumab

Placebo to match simtuzumab administered intravenously every 2 weeks for a total of 2 infusions (Days 1 and 15)

Sponsors & Collaborators

Principal Investigators

  • Zung Thai, MD · Gilead Sciences

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
TRIPLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2011-11-30
Primary Completion
2013-10-31
Completion
2015-02-28

Countries

  • United States
  • Russia

Study Locations

More Related Trials

Entities

Drugs
Diseases
Companies

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 NCT01472198 on ClinicalTrials.gov