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

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

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

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
      • Bakersfield, California, United States, 93309
        • Comprehensive Blood & Cancer Center
      • Encinitas, California, United States, 92024
        • Pacific Oncology & Hematology Associates
      • Encinitas, California, United States, 92024
        • Pacific Oncology and Hematology Associates
      • Fresno, California, United States, 93710
        • Advanced Medical Research Institute
      • Los Angeles, California, United States, 90057
        • Kenmar Research Institute
      • Los Angeles, California, United States, 90057
        • Kenmar Clinical Research
      • Santa Monica, California, United States, 90403
        • Sant Chawla, Inc.
    • Florida
      • Brandon, Florida, United States, 33511
        • PAB Clinical Research
      • Melbourne, Florida, United States, 32901
        • Melbourne Internal Medicine Associates
      • Melbourne, Florida, United States, 32901
        • Osler Medical, Inc./ Osler Clinical Research
      • Tampa, Florida, United States, 33607
        • Bay Area Oncology
    • Maryland
      • Bethesda, Maryland, United States, 20817
        • Center for Cancer and Blood Disorders
    • Ohio
      • Columbus, Ohio, United States, 43235
        • Hematology Oncology Consultants, Inc.
    • South Carolina
      • Charleston, South Carolina, United States, 29406
        • Charleston Cancer Center
      • Columbia, South Carolina, United States, 29210
        • South Carolina Oncology Associates
      • Hilton Head Island, South Carolina, United States, 29926
        • South Carolina Cancer Specialists
    • Texas
      • Galveston, Texas, United States, 77555
        • University of Texas Medical Texas
    • Washington
      • 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 ≥ 18 years of age with incurable,histologically diagnosed cancer.
  • Involuntary loss of body weight of ≥ 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

  • Allocation: RANDOMIZED
  • Interventional Model: PARALLEL
  • Masking: DOUBLE

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
PLACEBO_COMPARATOR: Placebo
Drug: Placebo
ACTIVE_COMPARATOR: RC-1291 HCl
50 mg
Drug: RC-1291 HCl

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Body weight
Lean body mass
Functional performance

Collaborators and Investigators

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

Sponsor

Helsinn Therapeutics (U.S.), Inc

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

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

November 1, 2005

Primary Completion (ACTUAL)

October 1, 2006

Study Completion (ACTUAL)

October 1, 2006

Study Registration Dates

First Submitted

December 19, 2005

First Submitted That Met QC Criteria

December 19, 2005

First Posted (ESTIMATE)

December 20, 2005

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-1291-205

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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