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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 is a Phase 3 study that has completed, run by ImmunoGenesis. The registered enrollment target is 693 participants.
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.
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 |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT01746979
The ClinicalTrials.gov registry entry for NCT01746979 describes a study currently listed as completed, categorized as Phase 3. The registered enrollment target is 693 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is ImmunoGenesis, which has 8 total studies on file at ClinicalTrials.gov.
The record links to 0 conditions, and to 3 interventions - of which Gemcitabine is the first listed.
NCT01746979 reports 0 study locations.
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.
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