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

Status

Indicates the current recruitment status or the expanded access status.
Terminated

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Anticipated)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
153

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • 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 Británico 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 Oncología
      • 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

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

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

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
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

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Time Frame
Overall Survival
Time Frame: 18 months
18 months

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
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

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
SciClone Pharmaceuticals

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • 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

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
September 1, 2007

Primary Completion (Actual)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
August 1, 2009

Study Completion (Actual)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
October 1, 2009

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
October 25, 2007

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
October 25, 2007

First Posted (Estimate)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
October 26, 2007

Study Record Updates

Last Update Posted (Estimate)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
June 8, 2011

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
June 6, 2011

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
October 1, 2009

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant 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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