Status:
COMPLETED
Placebo Controlled, Randomized Safety and Efficacy Study of RC-1291 in Cancer Anorexia/Cachexia
Lead Sponsor:
Helsinn Therapeutics (U.S.), Inc
Conditions:
Cancer Cachexia
Eligibility:
All Genders
18+ years
Phase:
PHASE2
Brief 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 rever...
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...
Eligibility Criteria
Inclusion
- 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
- 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.
Key Trial Info
Start Date :
September 1 2006
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
April 1 2007
Estimated Enrollment :
51 Patients enrolled
Trial Details
Trial ID
NCT00378131
Start Date
September 1 2006
End Date
April 1 2007
Last Update
September 2 2013
Active Locations (17)
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1
Palo Verde Hematology Oncology, Ltd.
Glendale, Arizona, United States, 85304
2
San Diego Pacific Oncology & Hematology Associates
Encinitas, California, United States, 92024
3
Sant P. Chawla, MD
Santa Monica, California, United States, 90403
4
Melbourne Internal Medicine Associates
Melbourne, Florida, United States, 32901