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

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

MedlinePlus related topics:

Cancer Pancreatic Cancer

ChemIDplus related topics:

Gemcitabine hydrochloride Gemcitabine

U.S. FDA Resources

Study Type:	Interventional
Study Design:	Health Services Research, Randomized, Double Blind (Subject, Caregiver, Investigator), Parallel Assignment, Safety/Efficacy Study

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

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
Estimated Study Completion Date:	August 2009
Estimated Primary Completion Date:	August 2009 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
Arm 1: Active Comparator RP101 and Gemcitabine	Drug: RP101 190 mg oral tablet Drug: Gemcitabine (1000 mg/m2) 30 minute intravenous infusion
Arm 2: Placebo Comparator Placebo and Gemcitabine	Drug: Gemcitabine (1000 mg/m2) 30 minute intravenous infusion

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

Contacts


Contact: Ruth Dye	650-358-3456	rdye@sciclone.com

Locations


United States, California
	Tower Research Foundation at Tower Oncology	Recruiting
	Beverly Hills, California, United States, 90211
	Contact: Linda Ford, PA-C 310-285-2768 fordl@toweroncology.com
	Principal Investigator: Peter J Rosen, MD

United States, Florida
	Lakeland Regional Cancer Center	Recruiting
	Lakeland, Florida, United States, 33805
	Contact: Robin Stewart 863-904-1877 robin.stewart@lrmc.com
	Contact: Madhavi Venigalla, MD

United States, North Dakota
	Mid Dakota Clinic	Recruiting
	Bismarck, North Dakota, United States, 58501
	Contact: Lindsey Tollefson 701-751-1128 ltollefson.legacy@midconetwork.com
	Contact: Amin Bipinkumar, MD 701-751-1128

United States, Ohio
	Gabrail Cancer Center	Recruiting
	Canton, Ohio, United States, 44718
	Contact: Carrie Smith 330-492-3345 research@gabrailcancercenter.com
	Principal Investigator: Nashat Y Gabrail, MD
	Signal Point Clinical Research Center, LLC	Recruiting
	Middletown, Ohio, United States, 45042
	Principal Investigator: Nandagopal Vrindavanam, MD

United States, Oregon
	Providence Portland Medical Center	Recruiting
	Portland, Oregon, United States, 97231
	Contact: Katie Strauss, RN 503-215-6725 katie.strauss@providence.org

United States, Pennsylvania
	St. Luke's Cancer Center	Recruiting
	Bethlehem, Pennsylvania, United States, 18015
	Contact: Kelly Filchner, MSN, RN, OCN 610-954-3583 filchnk@slhn.org
	Principal Investigator: Sanjiv Agarwala, MD

United States, Texas
	Baylor College of Medicine	Recruiting
	Houston, Texas, United States, 77030
	Contact: Glen Willson 713-789-4530 ggwillson@bcm.edu
	Contact: William Fisher, MD

United States, Washington
	Cancer Care Northwest	Recruiting
	Spokane, Washington, United States, 99202
	Contact: Rachel Garman 509-228-1481 rachel.garman@usoncology.com
	Contact: Robert Gersh, MD

United States, Wisconsin
	Medical College of Wisconsin, Froedtert Multi-Disciplinary Cancer Center	Recruiting
	Milwaukee, Wisconsin, United States, 53226
	Principal Investigator: Paul Ritch, MD

France
	Centre Eugene Marquis, Service d'Oncologie Medicale	Recruiting
	Rennes, France
	Principal Investigator: Jean-Luc Raoul, MD
	Hôpital Gabriel Montpied	Recruiting
	Clermont-Ferrand, France
	Principal Investigator: Denis Pezet, MD
	Centre Hospitalier Départemental	Recruiting
	La Roche sur Yon Cedex 9, France
	Principal Investigator: Roger Faroux

Hungary
	Debreceni Egyetem Orvos és Egészségtudományi Centrum, Onkológiai Tanszék	Recruiting
	Debrecen, Hungary
	Principal Investigator: János Szántó, MD

Hungary, BUDAPEST
	Petz Aladár Megyei Oktató Kórház Orvostovábbképzo Egyetem Oktató-Továbbképzo Kórháza, Onkoradiológia	Recruiting
	Gyor, BUDAPEST, Hungary
	Principal Investigator: Tamás Pintér, MD

Sponsors and Collaborators

SciClone Pharmaceuticals

Investigators


Study Chair:	Manuel Hidalgo, MD, PhD	Centro Integral de Oncologia

More Information

SciClone Website This link exits the ClinicalTrials.gov site

Responsible Party:	Sciclone Pharmaceuticals, Inc. ( Israel Rios, M.D )
Study ID Numbers:	SCI-RP-Pan-P2-001
First Received:	October 25, 2007
Last Updated:	July 22, 2008
ClinicalTrials.gov Identifier:	NCT00550004
Health Authority:	United States: Food and Drug Administration

Keywords provided by SciClone Pharmaceuticals:

Unresectable

locally advanced

metastatic pancreatic adenocarcinoma

Stage III

Stage IV

Study placed in the following topic categories:

Digestive System Diseases

Digestive System Neoplasms

Pancreatic Neoplasms

Endocrine System Diseases

Pancreatic Diseases

Gastrointestinal Neoplasms

Endocrinopathy

Gemcitabine

Adenocarcinoma

Endocrine Gland Neoplasms

Additional relevant MeSH terms:

Antimetabolites

Anti-Infective Agents

Antimetabolites, Antineoplastic

Molecular Mechanisms of Pharmacological Action

Immunologic Factors

Antineoplastic Agents

Physiological Effects of Drugs

Enzyme Inhibitors

Antiviral Agents

Immunosuppressive Agents

Pharmacologic Actions

Neoplasms

Neoplasms by Site

Radiation-Sensitizing Agents

Therapeutic Uses

ClinicalTrials.gov processed this record on October 17, 2008

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