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Phase II Study to Evaluate Efficacy and Safety of RP101 in Combination With Gemcitabine | Clinical Trials | Clareo Health

TERMINATEDPHASE2

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

NCT00550004•SciClone Pharmaceuticals

View on ClinicalTrials.gov

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).

Eligibility

Age

18 - No limit years

Sex

ALL

Healthy Volunteers

Inclusion Criteria

•Subjects must be 18 years of age or older
•Not previously treated with chemotherapy for Pancreatic Cancer
•ECOG performance status of 0 or 1
•Life expectancy \> 3 months
•Documentation of all sites of pancreatic disease within 28 days prior to randomization
•Adequate hematological, renal, and hepatic function
•Not pregnant or nursing
•Fertile subjects must practice a medically approved method of contraception

Exclusion Criteria

•Prior history of other malignant tumors
•Participation in another investigational study within 4 weeks prior to treatment start
•Major surgery within 14 days prior to treatment start
•Radiation treatment within 28 days prior to treatment start
•Uncontrolled cardiac atrial or ventricular arrhythmias
•Gastrointestinal tract disease such resulting in an inability to take oral medication
•Known to be seropositive for HIV, HBV, or HCV
•Uncontrolled cancer pain

Locations (55)

University of Arizona Medical Center, Arizona Cancer Center

Tucson, Arizona, United States

Tower Research Foundation at Tower Oncology

Beverly Hills, California, United States

University of California at San Francisco

San Francisco, California, United States

Integrated Community Oncology Network, LLC

Jacksonville, Florida, United States

Lakeland Regional Cancer Center

Lakeland, Florida, United States

Mid Dakota Clinic

Bismarck, North Dakota, United States

Gabrail Cancer Center

Canton, Ohio, United States

Signal Point Clinical Research Center, LLC

Middletown, Ohio, United States

Providence Portland Medical Center

Portland, Oregon, United States

St. Luke's Cancer Center

Bethlehem, Pennsylvania, United States

Key Dates

Start Date

September 1, 2007

Primary Completion Date

August 1, 2009

Completion Date

October 1, 2009

Last Updated

June 8, 2011

Enrollment

153

ESTIMATED participants

Conditions

Pancreatic Cancer

Interventions

RP101

DRUG

Gemcitabine (1000 mg/m2)

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Data Source & Attribution

This clinical trial information is sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.

ClinicalTrials.gov last update: June 8, 2011Data synced to Clareo: March 29, 2026

Modifications: This data has been reformatted for display purposes. Eligibility criteria have been parsed into inclusion/exclusion sections. Location data has been geocoded to enable distance-based search. For the authoritative and most current information, please visit ClinicalTrials.gov.

Neither the United States Government nor Clareo Health make any warranties regarding the data. Check ClinicalTrials.gov frequently for updates.

View ClinicalTrials.gov Terms and Conditions

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

Inclusion Criteria

Exclusion Criteria

Measuring the Effects of Talazoparib in Patients With Advanced Cancer and DNA Repair Variations

Testing A New Anti-cancer Drug Combination, Entinostat and ZEN003694, for Advanced and Refractory Solid Tumors

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PurIST Classification-Guided Adaptive Neoadjuvant Chemotherapy by RNA Expression Profiling of EUS Aspiration Samples

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