Clinical trialPhase 2Terminated
Phase II Study to Evaluate Efficacy and Safety of RP101 in Combination With Gemcitabine
Randomized, Double Blind, Placebo Controlled, Phase 2 Study Evaluating the Efficacy & Safety of RP101 or Placebo in Combination With Gemcitabine Administered as First-Line Treatment to Subjects With Unresectable, Locally Advanced, or Metastatic Pancreatic Adenocarcinoma
- Outcome
- Stopped early
- Phase
- Phase 2
- Status
- Terminated
- Study type
- Interventional
- Start
- September 2007
- Ended
- October 2009
- Enrollment
- 153 participants
- Sites
- 55
- Primary outcomes
- Overall Survival
- Sponsor type
- Industry
- Results posted
- No
- Last update
- 8 June 2011
These fields come from the trial’s registry entry. A summary of its population, design, endpoints and results, each tied to a quote, has not been written for this trial yet.
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Brief summary public domain (ClinicalTrials.gov)
This will be a Phase II, multicenter, randomized, double blind, placebo controlled, study of six 28-day treatment cycles for patients with locally advanced, unresectable, or metastatic pancreatic cancer. The study will be conducted at approximately 55 sites in the North American, Europe, and South America. Approximately 153 subjects will be enrolled in a randomization (ratio 2:1).
Papers 1
- Registry-listed results paperRP101 (brivudine) binds to heat shock protein HSP27 (HSPB1) and enhances survival in animals and pancreatic cancer pati… DOI 10.1007/s00432-011-1005-1↗
The registry lists these as results papers; in a hand check of 27 such links about 78% reported the trial’s results, so read the paper before treating it as the outcome.