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

June 6, 2011 updated by: SciClone Pharmaceuticals

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

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).

Study Overview

Status

Terminated

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Anticipated)

153

Phase

  • Phase 2

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Argentina
    • Buenos Aires
      • Bahía Blanca, Buenos Aires, Argentina
        • Hospital Italiano Regional Del Sur
      • Ciudad Autónoma de Buenos Aires, Buenos Aires, Argentina
        • Hospital Britanico de Buenos Aires
      • La Plata, Buenos Aires, Argentina
        • Hospital Zonal General de Agudos San Roque
  • Brazil
      • Ijuí, Brazil
        • Hospital de Caridade de Ijui
      • Porto Alegre, Brazil
        • Hospital de Clínicas de Porto Alegre, Serviço de Oncologia
      • Rio de Janeiro, Brazil
        • Instituto Nacional do Câncer
      • Salvador, Brazil
        • Nucleo de Oncologia da Bahia
      • São Paulo, Brazil
        • Hospital do Câncer-AC Camargo
  • Chile
      • Santiago, Chile
        • Fundacion Arturo Lopez Perez
      • Santiago de Chile, Chile
        • Hospital Militar
  • France
      • Clermont-Ferrand, France
        • Hôpital Gabriel Montpied
      • La Roche sur Yon Cedex 9, France
        • Centre Hospitalier Departemental
      • Rennes, France
        • Centre Eugene Marquis, Service d'Oncologie Medicale
  • Germany
      • Dresden, Germany
        • Universitätsklinikum Dresden, Med. Klinik I
      • Hannover, Germany
        • Klinikum Region Hannover GmbH, Krankenhause Siloah
      • München, Germany
        • Klinikum rechts der Isar, Technische Universität München
  • Hungary
      • Budapest, Hungary
        • Fovarosi Onkormanyzat Egyesitett Szent Istvan és Szent Laszlo Korhaz-Rendelointezet
      • Budapest, Hungary
        • Fovárosi Önkormányzat Uzsoki utcai Kórháza
      • Debrecen, Hungary
        • Debreceni Egyetem Orvos és Egészségtudományi Centrum, Onkológiai Tanszék
    • Budapest
      • Gyor, Budapest, Hungary
        • Petz Aladár Megyei Oktató Kórház Orvostovábbképzo Egyetem Oktató-Továbbképzo Kórháza, Onkoradiológia
  • Netherlands
      • Sittard, Netherlands
        • Maaslandziekenhuis
  • Peru
      • La Victoria, Peru
        • Hospital Nacional Guillermo Almenara Irigoyen
      • Lima, Peru
        • Hospital Nacional Edgardo Rebagliati Martins
      • San Borja, Peru
        • Instituto Oncocenter
  • Poland
      • Jelenia Góra, Poland
        • Samodzielny Publiczny Zaklad Opieki Zdrowotnej Szpital Wojewódzki
      • Kraków, Poland
        • I Katedra Chirurgii Ogólnej i Klinika Chirurgii Gastroenterologicznej
      • Lódz, Poland
        • Wojewódzki Szpital Specjalistyczny im Kopernika w Lodzi
      • Rzeszów, Poland
        • Centrum Medyczne MrukMed
  • Romania
      • Bucuresti, Romania
        • Institutul Clinic Fundeni
      • Bucuresti, Romania
        • Institutul Oncologic 'Prof. Dr. A. Trestioreanu'
      • Bucuresti, Romania
        • Spitalul Clinic de Urgenta Floreasca
      • Bucuresti, Romania
        • Spitalul Clinic Universitar de Urgenta
  • Spain
      • Lérida, Spain
        • Hospital Universitario Arnau de Vilanova, Servicio de Oncologia
      • Madrid, Spain
        • Centro Integral Oncologico Clara Campal, Hospital de Madrid Norte-San Chinarro
      • Madrid, Spain
        • Hospital 12 de Octubre, Oncology Service, Hospital Materno Infantil
      • Valencia, Spain
        • Instituto Valenciano de Oncologia
      • Zaragoza, Spain
        • Hospital Universitario Miguel Servet
  • United Kingdom
    • England
      • Leicester, England, United Kingdom
        • Leicester Royal Infirmary, University Hospitals of Leicester NHS Trust
      • Middlesex, England, United Kingdom
        • Mount Vernon Hospital
  • United States
    • Arizona
      • Tucson, Arizona, United States, 85724
        • University of Arizona Medical Center, Arizona Cancer Center
    • California
      • Beverly Hills, California, United States, 90211
        • Tower Research Foundation at Tower Oncology
      • San Francisco, California, United States, 94110
        • University of California at San Francisco
    • Florida
      • Jacksonville, Florida, United States, 32256
        • Integrated Community Oncology Network, LLC
      • Lakeland, Florida, United States, 33805
        • Lakeland Regional Cancer Center
    • North Dakota
      • Bismarck, North Dakota, United States, 58501
        • Mid Dakota Clinic
    • Ohio
      • Canton, Ohio, United States, 44718
        • Gabrail Cancer Center
      • Middletown, Ohio, United States, 45042
        • Signal Point Clinical Research Center, LLC
    • Oregon
      • Portland, Oregon, United States, 97231
        • Providence Portland Medical Center
    • Pennsylvania
      • Bethlehem, Pennsylvania, United States, 18015
        • St. Luke's Cancer Center
    • Texas
      • Houston, Texas, United States, 77030
        • Baylor College of Medicine
      • San Antonio, Texas, United States, 78207
        • South Texas Oncology and Hematology, PA
    • Utah
      • Salt Lake City, Utah, United States, 84106
        • Utah Cancer Specialists
    • Washington
      • Seattle, Washington, United States, 98109-1023
        • University of Washington
      • Spokane, Washington, United States, 99202
        • Cancer Care Northwest
    • Wisconsin
      • Milwaukee, Wisconsin, United States, 53226
        • Medical College of Wisconsin, Froedtert Multi-Disciplinary Cancer Center

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Health Services Research
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Triple

Arms and Interventions

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

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Overall Survival
Time Frame: 18 months
18 months

Secondary Outcome Measures

Outcome Measure
Time Frame
Progression Free Survival
Time Frame: 14 months
14 months
Evaluate the CA 19-9 levels
Time Frame: 12 months
12 months
Compare changes in ECOG
Time Frame: 12 months
12 months
Evaluate Safety of RP101
Time Frame: 18 months
18 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

SciClone Pharmaceuticals

Investigators

  • Study Chair: Manuel Hidalgo, MD, PhD, Centro Integral de Oncología

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Helpful Links

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

September 1, 2007

Primary Completion (Actual)

August 1, 2009

Study Completion (Actual)

October 1, 2009

Study Registration Dates

First Submitted

October 25, 2007

First Submitted That Met QC Criteria

October 25, 2007

First Posted (Estimate)

October 26, 2007

Study Record Updates

Last Update Posted (Estimate)

June 8, 2011

Last Update Submitted That Met QC Criteria

June 6, 2011

Last Verified

October 1, 2009

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • SCI-RP-Pan-P2-001

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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