Placebo Controlled, Randomized Safety and Efficacy Study of RC-1291 in Cancer Anorexia/Cachexia.
- Registration Number
- NCT00267358
- Lead Sponsor
- Helsinn Therapeutics (U.S.), Inc
- Brief Summary
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.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- Not specified
- Community-dwelling patients ≥ 18 years of age with incurable,histologically diagnosed cancer.
- Involuntary loss of body weight of ≥ 5 % within the past 6 months
- 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
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description RC-1291 HCl RC-1291 HCl 50 mg Placebo Placebo -
- Primary Outcome Measures
Name Time Method Functional performance Body weight Lean body mass
- Secondary Outcome Measures
Name Time Method
Trial Locations
- Locations (19)
Sant Chawla, Inc.
🇺🇸Santa Monica, California, United States
Hematology Oncology Consultants, Inc.
🇺🇸Columbus, Ohio, United States
Advanced Medical Research Institute
🇺🇸Fresno, California, United States
Kenmar Clinical Research
🇺🇸Los Angeles, California, United States
Osler Medical, Inc./ Osler Clinical Research
🇺🇸Melbourne, Florida, United States
Kenmar Research Institute
🇺🇸Los Angeles, California, United States
Palo Verde Hematology Oncology Ltd.
🇺🇸Glendale, Arizona, United States
Charleston Cancer Center
🇺🇸Charleston, South Carolina, United States
Melbourne Internal Medicine Associates
🇺🇸Melbourne, Florida, United States
South Carolina Cancer Specialists
🇺🇸Hilton Head Island, South Carolina, United States
South Carolina Oncology Associates
🇺🇸Columbia, South Carolina, United States
Comprehensive Blood & Cancer Center
🇺🇸Bakersfield, California, United States
PAB Clinical Research
🇺🇸Brandon, Florida, United States
University of Texas Medical Texas
🇺🇸Galveston, Texas, United States
Pacific Oncology & Hematology Associates
🇺🇸Encinitas, California, United States
Pacific Oncology and Hematology Associates
🇺🇸Encinitas, California, United States
Center for Cancer and Blood Disorders
🇺🇸Bethesda, Maryland, United States
Bay Area Oncology
🇺🇸Tampa, Florida, United States
Multicare Health System
🇺🇸Tacoma, Washington, United States