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Clinical Trial Testing TH-302 in Combination With Gemcitabine in Previously Untreated Subjects With Metastatic or Locally Advanced Unresectable Pancreatic Adenocarcinoma

NCT01746979 · Status: COMPLETED · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 693

Last updated 2025-05-11

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Summary

This Phase 3 trial is a randomized, double-blind, placebo-controlled trial of gemcitabine in combination with TH-302 compared to gemcitabine in combination with placebo in subjects with locally advanced unresectable or metastatic pancreatic adenocarcinoma. Randomized subjects will receive TH-302 plus gemcitabine or gemcitabine plus placebo in 4-week cycles until there is evidence of progressive disease, intolerable toxicity, or the subject discontinues from the trial for other reasons (for example, withdrawal of consent). The primary efficacy endpoint is overall survival (OS) time. The data cut-off for statistical analyses of the primary and secondary endpoints will be reached when 508 events (deaths) will be reported. No planned interim analyses will be conducted. An Independent Safety Monitoring Board (ISMB) will provide periodic evaluations of the unblinded safety data to ensure subject safety and the validity and scientific merit of the study. A total of 660 subjects will be enrolled.

Conditions

  • Metastatic or Locally Advanced Unresectable Pancreatic Adenocarcinoma

Interventions

DRUG

TH-302

TH-302 will be administered at a dose of 340 milligrams per square meter (mg/m\^2) as intravenous infusion over 30 minutes on Day 1, 8 and 15 of every 28-day cycle. Doses will be administered until evidence of progressive disease, intolerable toxicity or subject withdrawal.

DRUG

Gemcitabine

Gemcitabine will be administered at a dose of 1000 (mg/m\^2) as intravenous infusion over 30 minutes on Day 1, 8 and 15 of every 28-day cycle. Doses will be administered until evidence of progressive disease, intolerable toxicity or subject withdrawal.

DRUG

Placebo (5 percent dextrose - D5W)

TH-302 placebo (5 percent dextrose - D5W) will be administered as intravenous infusion over 30 minutes on Day 1, 8 and 15 of every 28-day cycle. Doses will be administered until evidence of progressive disease, intolerable toxicity or subject withdrawal.

Sponsors & Collaborators

  • Threshold Pharmaceuticals

    collaborator INDUSTRY

  • ImmunoGenesis

    lead INDUSTRY

Principal Investigators

  • Antonio Gualberto, MD, PhD · EMD Serono Inc., a subsidiary of Merck KGaA, Darmstadt, Germany

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2012-12-31
Primary Completion
2016-02-29
Completion
2016-05-31

Countries

  • United States
  • Germany

Study Locations

More Related Trials

Entities

Drugs

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 NCT01746979 on ClinicalTrials.gov