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

Phase 2

Terminated

• Conditions: Pancreatic Cancer
• Interventions: Drug: RP101; Drug: Gemcitabine (1000 mg/m2)

• Registration Number: NCT00550004
• Lead Sponsor: SciClone Pharmaceuticals

Brief 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).

Detailed Description

Not available

Study Timeline

• Study Start: 2007-09
• Study First Submitted: 2007-10-25
• Study First Submitted QC: 2007-10-25
• Study First Posted: 2007-10-26
• Primary Completion: 2009-08
• Status Verified: 2009-10
• Study Completion: 2009-10
• Last Update Submitted: 2011-06-06
• Last Update Posted: 2011-06-08

Recruitment & Eligibility

• Status: TERMINATED
• Sex: All
• Target Recruitment: 153

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Arm 1	RP101	RP101 and Gemcitabine
Arm 1	Gemcitabine (1000 mg/m2)	RP101 and Gemcitabine
Arm 2	Gemcitabine (1000 mg/m2)	Placebo and Gemcitabine

Primary Outcome Measures

Name	Time	Method
Overall Survival	18 months

Secondary Outcome Measures

Name	Time	Method
Progression Free Survival	14 months
Evaluate the CA 19-9 levels	12 months
Compare changes in ECOG	12 months
Evaluate Safety of RP101	18 months

Trial Locations

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

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