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

S

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: RP101
Drug: Gemcitabine (1000 mg/m2)
Arm 2
Placebo Comparator group
Description:
Placebo and Gemcitabine
Treatment:
Drug: Gemcitabine (1000 mg/m2)

Trial contacts and locations

0

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Data sourced from clinicaltrials.gov

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