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NCT01746979 · ClinicalTrials.gov registry record · Phase 3
Clinical Trial Testing TH-302 in Combination With Gemcitabine in Previously Untreated Subjects With Metastatic or Locally Advanced Unresectable Pancreatic Adenocarcinoma
A Phase 3 study, sponsored by ImmunoGenesis.
- Completed
- Registry status
- Phase 3
- Development phase
- 693
- Enrollment target
NCT01746979: Completed Phase 3 study, sponsored by ImmunoGenesis.
NCT01746979 is a Phase 3 study that has completed, run by ImmunoGenesis. The registered enrollment target is 693 participants, below the 772-participant average among 15,282 other Phase 3 trials with a reported enrollment target (10% lower). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT01746979, a Phase 3 study, has completed, sponsored by ImmunoGenesis.
- COMPLETED
- Registry status
- Phase 3
- Development phase
- 693 participants
- Enrollment target
Study 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.
Primary Outcome
Overall survival is defined as time from randomization to death or last day known to be alive.
Interventions
- DRUG Gemcitabine
- DRUG TH-302
- DRUG Placebo (5 percent dextrose - D5W)
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 693 participants |
| Start Date | 2012-12 |
| Est. Completion | 2016-05 |
| Phase | Phase 3 |
What the finished NCT01746979 record still lists
NCT01746979 is an interventional study that assigns participants to a tested intervention. The registered 693 participants enrollment target is mid-sized for trials with a published cap, below the 772-participant average among 15,282 other Phase 3 trials with a reported enrollment target (10% lower).
The record links to 0 conditions, and to 3 interventions - of which Gemcitabine is the first listed.
NCT01746979 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT01746979 about?
NCT01746979 is a clinical study titled "Clinical Trial Testing TH-302 in Combination With Gemcitabine in Previously Untreated Subjects With Metastatic or Locally Advanced Unresectable Pancreatic Adenocarcinoma". 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 plu...
What is the current status of trial NCT01746979?
This trial is currently completed. It is a Phase 3 study. The enrollment target is 693 participants. The study started on 2012-12. Estimated completion is 2016-05.
What interventions are being tested in trial NCT01746979?
The interventions under investigation include: Gemcitabine (DRUG), TH-302 (DRUG), Placebo (5 percent dextrose - D5W) (DRUG).
Who is sponsoring clinical trial NCT01746979?
This trial is sponsored by ImmunoGenesis, which has 8 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT01746979's enrollment target sits among peer trials
693 519th of 2000 higher than 1,481 of 2,000 other Phase 3 trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Phase 3 trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
Source ClinicalTrials.gov registry export · 2026-08-08
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