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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT00550004
Recruitment Status : Terminated
First Posted : October 26, 2007
Last Update Posted : June 8, 2011
Information provided by:
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).

Condition or disease Intervention/treatment Phase
Pancreatic Cancer Drug: RP101 Drug: Gemcitabine (1000 mg/m2) Phase 2

Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 153 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple (Participant, Care Provider, Investigator)
Primary Purpose: Health Services Research
Official Title: 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
Study Start Date : September 2007
Actual Primary Completion Date : August 2009
Actual Study Completion Date : October 2009

Resource links provided by the National Library of Medicine

Arm Intervention/treatment
Active Comparator: Arm 1
RP101 and Gemcitabine
Drug: RP101
190 mg oral tablet

Drug: Gemcitabine (1000 mg/m2)
30 minute intravenous infusion
Other Name: Gemzar

Placebo Comparator: Arm 2
Placebo and Gemcitabine
Drug: Gemcitabine (1000 mg/m2)
30 minute intravenous infusion
Other Name: Gemzar

Primary Outcome Measures :
  1. Overall Survival [ Time Frame: 18 months ]

Secondary Outcome Measures :
  1. Progression Free Survival [ Time Frame: 14 months ]
  2. Evaluate the CA 19-9 levels [ Time Frame: 12 months ]
  3. Compare changes in ECOG [ Time Frame: 12 months ]
  4. Evaluate Safety of RP101 [ Time Frame: 18 months ]

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT00550004

  Show 55 Study Locations
Sponsors and Collaborators
SciClone Pharmaceuticals
Study Chair: Manuel Hidalgo, MD, PhD Centro Integral de Oncologia

Additional Information:
Publications automatically indexed to this study by Identifier (NCT Number):
Responsible Party: Israel Rios, M.D, Sciclone Pharmaceuticals, Inc. Identifier: NCT00550004     History of Changes
Other Study ID Numbers: SCI-RP-Pan-P2-001
First Posted: October 26, 2007    Key Record Dates
Last Update Posted: June 8, 2011
Last Verified: October 2009

Keywords provided by SciClone Pharmaceuticals:
locally advanced
metastatic pancreatic adenocarcinoma
Stage III
Stage IV

Additional relevant MeSH terms:
Pancreatic Neoplasms
Digestive System Neoplasms
Neoplasms by Site
Endocrine Gland Neoplasms
Digestive System Diseases
Pancreatic Diseases
Endocrine System Diseases
Antimetabolites, Antineoplastic
Molecular Mechanisms of Pharmacological Action
Antineoplastic Agents
Antiviral Agents
Anti-Infective Agents
Enzyme Inhibitors
Immunosuppressive Agents
Immunologic Factors
Physiological Effects of Drugs