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Study of the Safety and Efficacy of TH-302 in Combination With Gemcitabine Compared With Gemcitabine Alone in Previously Untreated Patients With Pancreatic Adenocarcinoma

NCT01144455 · Status: COMPLETED · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 214

Last updated 2025-05-11

Study results available
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Summary

The purpose of this study is to determine whether Gemcitabine versus Gemcitabine and TH-302 are effective in the treatment of subjects with first-line metastatic pancreatic adenocarcinoma.

Conditions

  • Pancreatic Adenocarcinoma

Interventions

DRUG

Gemzar (Gemcitabine)

1,000 mg/m2 administered IV over 30 minutes on Days 1, 8 and 15 of a 28-day cycle.

DRUG

TH-302

240 mg/m2 of TH-302 will be administered IV over 30 minutes on Days 1, 8 and 15 of every 28-day cycle.

DRUG

TH-302

340 mg/m2 of TH-302 will be administered IV over 30 minutes on Days 1, 8 and 15 of every 28-day cycle.

Sponsors & Collaborators

  • PRA Health Sciences

    collaborator INDUSTRY

  • ImmunoGenesis

    lead INDUSTRY

Principal Investigators

  • Mitesh Borad, MD · Mayo Clinic

  • Shantan Reddy, MD · Lousiana Health Sciences Center - Shreveport

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2010-06-30
Primary Completion
2013-09-30
Completion
2014-12-31

Countries

  • United States

Study Locations

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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 NCT01144455 on ClinicalTrials.gov