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Phase II Study to Evaluate Efficacy and Safety of RP101 in Combination With Gemcitabine

NCT00550004 · Status: TERMINATED · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 153

Last updated 2011-06-08

No results posted yet for this study

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

Interventions

DRUG

RP101

190 mg oral tablet

DRUG

Gemcitabine (1000 mg/m2)

30 minute intravenous infusion

Sponsors & Collaborators

  • SciClone Pharmaceuticals

    lead INDUSTRY

Principal Investigators

  • Manuel Hidalgo, MD, PhD · Centro Integral de Oncologia

Study Design

Allocation
RANDOMIZED
Purpose
HEALTH_SERVICES_RESEARCH
Masking
TRIPLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2007-09-30
Primary Completion
2009-08-31
Completion
2009-10-31

Countries

  • United States
  • Argentina
  • Brazil
  • Chile
  • France
  • Germany
  • Hungary
  • Netherlands
  • Peru
  • Poland
  • Romania
  • Spain
  • United Kingdom

Study Locations

More Related Trials

Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT00550004 on ClinicalTrials.gov