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

This study has been terminated.
Sponsor:
Information provided by:
SciClone Pharmaceuticals
ClinicalTrials.gov Identifier:
NCT00550004
First received: October 25, 2007
Last updated: June 6, 2011
Last verified: October 2009
History of Changes
  Purpose

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 Intervention Phase
Pancreatic Cancer
 Drug: RP101
Drug: Gemcitabine (1000 mg/m2)
 Phase 2

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, 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

Resource links provided by NLM:

U.S. FDA Resources

Further study details as provided by SciClone Pharmaceuticals:

Primary Outcome Measures:
  • Overall Survival [ Time Frame: 18 months ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Progression Free Survival [ Time Frame: 14 months ] [ Designated as safety issue: No ]
  • Evaluate the CA 19-9 levels [ Time Frame: 12 months ] [ Designated as safety issue: No ]
  • Compare changes in ECOG [ Time Frame: 12 months ] [ Designated as safety issue: No ]
  • Evaluate Safety of RP101 [ Time Frame: 18 months ] [ Designated as safety issue: No ]

Estimated Enrollment: 153
Study Start Date: September 2007
Study Completion Date: October 2009
Primary Completion Date: August 2009 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00550004

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

Additional Information:
SciClone Website  This link exits the ClinicalTrials.gov site

No publications provided

Responsible Party: Israel Rios, M.D, Sciclone Pharmaceuticals, Inc.
ClinicalTrials.gov Identifier: NCT00550004     History of Changes
Other Study ID Numbers: SCI-RP-Pan-P2-001
Study First Received: October 25, 2007
Last Updated: June 6, 2011
Health Authority: United States: Food and Drug Administration

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

Additional relevant MeSH terms:
Adenocarcinoma
Pancreatic Neoplasms
Carcinoma
Neoplasms, Glandular and Epithelial
Neoplasms by Histologic Type
Neoplasms
Digestive System Neoplasms
Neoplasms by Site
Endocrine Gland Neoplasms
Digestive System Diseases
Pancreatic Diseases
Endocrine System Diseases
Gemcitabine
 Antimetabolites, Antineoplastic
Antimetabolites
Molecular Mechanisms of Pharmacological Action
Pharmacologic Actions
Antineoplastic Agents
Therapeutic Uses
Antiviral Agents
Anti-Infective Agents
Enzyme Inhibitors
Immunosuppressive Agents
Immunologic Factors
Physiological Effects of Drugs
Radiation-Sensitizing Agents

ClinicalTrials.gov processed this record on May 16, 2013