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NCT01144455 · ClinicalTrials.gov registry record · Phase 2
Study of the Safety and Efficacy of TH-302 in Combination With Gemcitabine Compared With Gemcitabine Alone in Previously Untreated Patients With Pancreatic Adenocarcinoma
A Phase 2 study, sponsored by ImmunoGenesis.
- Completed
- Registry status
- Phase 2
- Development phase
- 214
- Enrollment target
NCT01144455: Completed Phase 2 study, sponsored by ImmunoGenesis.
NCT01144455 is a Phase 2 study that has completed, run by ImmunoGenesis. The registered enrollment target is 214 participants, above the 133-participant average among 30,622 other Phase 2 trials with a reported enrollment target (61% higher). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT01144455, a Phase 2 study, has completed, sponsored by ImmunoGenesis.
- COMPLETED
- Registry status
- Phase 2
- Development phase
- 214 participants
- Enrollment target
Study 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.
Primary Outcome
Progression is defined using Response Evaluation Criteria In Solid Tumors Criteria (RECIST), as a 20% increase in the sum of the longest diameter of target lesions, or a measurable increase in a non-target lesion, or the appearance of new lesions
Interventions
- DRUG TH-302
- DRUG Gemzar (Gemcitabine)
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 214 participants |
| Start Date | 2010-06 |
| Est. Completion | 2014-12 |
| Phase | Phase 2 |
What the finished NCT01144455 record still lists
NCT01144455 is an interventional study that assigns participants to a tested intervention. The registered 214 participants enrollment target is mid-sized for trials with a published cap, above the 133-participant average among 30,622 other Phase 2 trials with a reported enrollment target (61% higher).
The record links to 0 conditions, and to 2 interventions - of which TH-302 is the first listed.
NCT01144455 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT01144455 about?
NCT01144455 is a clinical study titled "Study of the Safety and Efficacy of TH-302 in Combination With Gemcitabine Compared With Gemcitabine Alone in Previously Untreated Patients With Pancreatic Adenocarcinoma". 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.
What is the current status of trial NCT01144455?
This trial is currently completed. It is a Phase 2 study. The enrollment target is 214 participants. The study started on 2010-06. Estimated completion is 2014-12.
What interventions are being tested in trial NCT01144455?
The interventions under investigation include: TH-302 (DRUG), Gemzar (Gemcitabine) (DRUG).
Who is sponsoring clinical trial NCT01144455?
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 NCT01144455's enrollment target sits among peer trials
214 290th of 2000 higher than 1,711 of 2,000 other Phase 2 trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Phase 2 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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