Placebo Controlled, Randomized Safety and Efficacy Study of RC-1291 in Cancer Anorexia/Cachexia

August 30, 2013 updated by: Helsinn Therapeutics (U.S.), Inc

A 12-Week, Double-Blind, Randomized, Placebo-Controlled, Parallel Group Phase II Study Comparing the Safety, Tolerability and Beneficial Effects of Daily Doses of RC-1291 and Placebo in Patients With Cancer Anorexia/Cachexia

Activation of Ghrelin receptors have been demonstrated to stimulate appetite. RC-1291 HCl, by virtue of its ghrelin like activity and Growth Hormone releasing effects may have a dual role in the reversal of cancer induced anorexia and cachexia. This placebo controlled study will evaluate the safety and efficacy of RC-1291 HCl in cancer patients with cachexia.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

Anorexia and cachexia are devastating complications in late-stage cancer patients and is strongly associated with mortality in these patients. Activation of Ghrelin receptors have been demonstrated to stimulate appetite. RC-1291 HCl, by virtue of its ghrelin like activity and Growth Hormone releasing effects may have a dual role in the reversal of cancer induced anorexia and cachexia. This placebo controlled study will evaluate the safety and efficacy of RC-1291 HCl in cancer patients with anorexia and cachexia.

Study Type

Interventional

Enrollment (Actual)

51

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

  • United States
    • Arizona
      • Glendale, Arizona, United States, 85304
        • Palo Verde Hematology Oncology, Ltd.
    • California
      • Encinitas, California, United States, 92024
        • San Diego Pacific Oncology & Hematology Associates
      • Santa Monica, California, United States, 90403
        • Sant P. Chawla, MD
    • Florida
      • Melbourne, Florida, United States, 32901
        • Melbourne Internal Medicine Associates
    • Louisiana
      • Lafayette, Louisiana, United States, 70503
        • Southwest Oncology Associates
    • Maryland
      • Bethesda, Maryland, United States, 20817
        • Center for Cancer and Blood Disorders
      • Glen Burnie, Maryland, United States, 21061
        • Chesapeake Oncology Hematology Associates, PA
    • New York
      • New York, New York, United States, 10003
        • Beth Israel Cancer Center
    • South Carolina
      • Charleston, South Carolina, United States, 29406
        • Charleston Cancer Center
      • Columbia, South Carolina, United States, 29210
        • South Carolina Oncology Associates, PA
      • Hilton Head Island, South Carolina, United States, 29926
        • South Carolina Cancer Specialists
    • Texas
      • Galveston, Texas, United States, 77555
        • University of Texas Medical Branch
      • Houston, Texas, United States, 77030
        • Michael E. DeBakey VA Medical Center
    • Virginia
      • Abingdon, Virginia, United States, 24211
        • Cancer Outreach Associates
      • Richmond, Virginia, United States, 23230
        • Virginia Cancer Institute
    • Washington
      • Tacoma, Washington, United States, 98405
        • Northwest Medical Specialties
      • Tacoma, Washington, United States, 98405
        • MultiCare Health System

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:

  • Community-dwelling patients greater than 18 years of age with incurable, histologically diagnosed cancer.
  • Involuntary loss of body weight greater than 5% within the past 6 months

Exclusion Criteria:

  • Presently hospitalized or in a nursing care facility.
  • Inability to increase food intake from secondary causes.
  • Liver disease
  • If female-pregnant, breast-feeding or of childbearing potential.

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: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Triple

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Placebo Comparator: 1
Drug: placebo
Experimental: 2
RC-1291 50mg
Drug: RC-1291
Experimental: 3
RC-1291 100mg
Drug: RC-1291

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Body weight; Lean body mass; Functional performance
Time Frame: 4 weeks
4 weeks

Collaborators and Investigators

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

Sponsor

Helsinn Therapeutics (U.S.), Inc

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, 2006

Primary Completion (Actual)

April 1, 2007

Study Completion (Actual)

April 1, 2007

Study Registration Dates

First Submitted

September 18, 2006

First Submitted That Met QC Criteria

September 18, 2006

First Posted (Estimate)

September 19, 2006

Study Record Updates

Last Update Posted (Estimate)

September 2, 2013

Last Update Submitted That Met QC Criteria

August 30, 2013

Last Verified

August 1, 2013

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • RC-1291-206

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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