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NCT01360853 · ClinicalTrials.gov registry record · Phase 3
Gemcitabine and ON 01910.Na in Previously Untreated Metastatic Pancreatic Cancer
A Phase 3 study, sponsored by Traws Pharma.
- Completed
- Registry status
- Phase 3
- Development phase
- 160
- Enrollment target
NCT01360853: Completed Phase 3 study, sponsored by Traws Pharma.
NCT01360853 is a Phase 3 study that has completed, run by Traws Pharma. The registered enrollment target is 160 participants, below the 772-participant average among 15,282 other Phase 3 trials with a reported enrollment target (79% lower). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT01360853, a Phase 3 study, has completed, sponsored by Traws Pharma.
- COMPLETED
- Registry status
- Phase 3
- Development phase
- 160 participants
- Enrollment target
Study Summary
The question being asked in this study is: Will patients with advanced pancreatic cancer live significantly longer if they are treated with a combination of Gemcitabine and ON 01910.Na than if they are treated with Gemcitabine alone? There are two parts to this study. In the first part of the study, patients with metastatic pancreatic cancer who have received no prior chemotherapy for this disease will be assigned by chance either to the group that will be treated with both Gemcitabine and ON 01910.Na (about 100 patients will be in this group) or, to the group that will be treated with Gemcitabine only (about 50 patients will be in this group). How long patients survive in the 2 groups will be compared. If it looks like there is no difference between the groups, the study will stop. If it looks like patients in the group that were treated with both Gemcitabine and ON 01910.Na survive longer, the study will continue into a second part where more patients will be treated in order to confirm and better understand the findings of the first part of the study.
Primary Outcome
This study's primary outcome is overall survival, defined as the time from randomization to death from any cause. All patients will be followed until death. Patients lost to follow-up will be censored at the time last known alive.
Interventions
- DRUG Gemcitabine
- DRUG ON 01910.Na
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 160 participants |
| Start Date | 2011-05 |
| Est. Completion | 2015-12 |
| Phase | Phase 3 |
What the finished NCT01360853 record still lists
NCT01360853 is an interventional study that assigns participants to a tested intervention. The registered 160 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 (79% lower).
The record links to 0 conditions, and to 2 interventions - of which Gemcitabine is the first listed.
NCT01360853 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT01360853 about?
NCT01360853 is a clinical study titled "Gemcitabine and ON 01910.Na in Previously Untreated Metastatic Pancreatic Cancer". The question being asked in this study is: Will patients with advanced pancreatic cancer live significantly longer if they are treated with a combination of Gemcitabine and ON 01910.Na than if they are treated with Gemcitabine alone? There are two parts to this study. In the first part of the study,...
What is the current status of trial NCT01360853?
This trial is currently completed. It is a Phase 3 study. The enrollment target is 160 participants. The study started on 2011-05. Estimated completion is 2015-12.
What interventions are being tested in trial NCT01360853?
The interventions under investigation include: Gemcitabine (DRUG), ON 01910.Na (DRUG).
Who is sponsoring clinical trial NCT01360853?
This trial is sponsored by Traws Pharma, which has 25 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT01360853's enrollment target sits among peer trials
160 1479th of 2000 higher than 500 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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