Phase II Study to Evaluate Efficacy and Safety of RP101 in Combination With Gemcitabine - Full Text View

Sponsor:	SciClone Pharmaceuticals
Information provided by:	SciClone Pharmaceuticals
ClinicalTrials.gov Identifier:	NCT00550004

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 II

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:

MedlinePlus related topics: Cancer Pancreatic Cancer

Drug Information available for: Gemcitabine Gemcitabine hydrochloride

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 February 09, 2012