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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT00378131
Other study ID # RC-1291-206
Secondary ID
Status Completed
Phase Phase 2
First received September 18, 2006
Last updated August 30, 2013
Start date September 2006
Est. completion date April 2007

Study information

Verified date August 2013
Source Helsinn Therapeutics (U.S.), Inc
Contact n/a
Is FDA regulated No
Health authority United States: Food and Drug Administration
Study type Interventional

Clinical Trial Summary

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.


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.


Recruitment information / eligibility

Status Completed
Enrollment 51
Est. completion date April 2007
Est. primary completion date April 2007
Accepts healthy volunteers No
Gender Both
Age group 18 Years and older
Eligibility 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 Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator), Primary Purpose: Treatment


Related Conditions & MeSH terms


Intervention

Drug:
RC-1291

placebo


Locations

Country Name City State
United States Cancer Outreach Associates Abingdon Virginia
United States Center for Cancer and Blood Disorders Bethesda Maryland
United States Charleston Cancer Center Charleston South Carolina
United States South Carolina Oncology Associates, PA Columbia South Carolina
United States San Diego Pacific Oncology & Hematology Associates Encinitas California
United States University of Texas Medical Branch Galveston Texas
United States Chesapeake Oncology Hematology Associates, PA Glen Burnie Maryland
United States Palo Verde Hematology Oncology, Ltd. Glendale Arizona
United States South Carolina Cancer Specialists Hilton Head Island South Carolina
United States Michael E. DeBakey VA Medical Center Houston Texas
United States Southwest Oncology Associates Lafayette Louisiana
United States Melbourne Internal Medicine Associates Melbourne Florida
United States Beth Israel Cancer Center New York New York
United States Virginia Cancer Institute Richmond Virginia
United States Sant P. Chawla, MD Santa Monica California
United States Multicare Health System Tacoma Washington
United States Northwest Medical Specialties Tacoma Washington

Sponsors (1)

Lead Sponsor Collaborator
Helsinn Therapeutics (U.S.), Inc

Country where clinical trial is conducted

United States, 

Outcome

Type Measure Description Time frame Safety issue
Primary Body weight; Lean body mass; Functional performance 4 weeks No
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