Phase II Study to Evaluate Efficacy and Safety of RP101 in Combination With Gemcitabine
This study is currently recruiting participants.
Verified by SciClone Pharmaceuticals, January 2009
Sponsored by:
SciClone Pharmaceuticals
Information provided by:
SciClone Pharmaceuticals
ClinicalTrials.gov Identifier:
NCT00550004
Purpose
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).
Health Services Research, Randomized, Double Blind (Subject, Caregiver, Investigator), Parallel Assignment, Safety/Efficacy Study
Official Title:
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
Further study details as provided by SciClone Pharmaceuticals:
Primary Outcome Measures:
Overall Survival [ Time Frame: 18 months ] [ Designated as safety issue: No ]
Secondary Outcome Measures:
Progression Free Survival [ Time Frame: 14 months ] [ Designated as safety issue: No ]
Evaluate the CA 19-9 levels [ Time Frame: 12 months ] [ Designated as safety issue: No ]
Compare changes in ECOG [ Time Frame: 12 months ] [ Designated as safety issue: No ]
Evaluate Safety of RP101 [ Time Frame: 18 months ] [ Designated as safety issue: No ]
Estimated Enrollment:
153
Study Start Date:
September 2007
Estimated Study Completion Date:
August 2009
Estimated Primary Completion Date:
August 2009 (Final data collection date for primary outcome measure)
Ongoing Ph II/III Trial
Purpose 
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