NCT00550004

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

• Status: Terminated
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 153 (estimated)
• Sponsor: SciClone Pharmaceuticals · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

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).

Conditions

• Pancreatic Cancer

Interventions

Type	Name	Description
DRUG	RP101	190 mg oral tablet
DRUG	Gemcitabine (1000 mg/m2)	30 minute intravenous infusion

Timeline

• Start date: 2007-09-01
• Primary completion: 2009-08-01
• Completion: 2009-10-01
• First posted: 2007-10-26
• Last updated: 2011-06-08

Locations

55 sites across 13 countries: United States, Argentina, Brazil, Chile, France, Germany, Hungary, Netherlands, Peru, Poland, Romania, Spain, United Kingdom