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

SciClone Pharmaceuticals

Status and phase: Terminated; Phase 2

Conditions: Pancreatic Cancer

Treatments: Drug: Gemcitabine (1000 mg/m2); Drug: RP101

Study type: Interventional

Funder types: Industry

Identifiers

NCT00550004

SCI-RP-Pan-P2-001

Details and patient eligibility

About

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).

Enrollment: 153 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No 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

Trial design

Primary purpose: Health Services Research

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Triple Blind

---

153 participants in 2 patient groups, including a placebo group

Arm 1

Active Comparator group

Description:

RP101 and Gemcitabine

Treatment:

Drug: Gemcitabine (1000 mg/m2)

Drug: RP101

Arm 2

Placebo Comparator group

Description:

Placebo and Gemcitabine

Treatment:

Drug: Gemcitabine (1000 mg/m2)