Placebo Controlled, Randomized Safety and Efficacy Study of RC-1291 in Cancer Anorexia/Cachexia.
This study has been completed.
Sponsor:
Helsinn Therapeutics (U.S.), Inc
Information provided by:
Helsinn Therapeutics (U.S.), Inc
ClinicalTrials.gov Identifier:
NCT00267358
First received: December 19, 2005
Last updated: June 30, 2009
Last verified: June 2009
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Purpose
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.
| Condition | Intervention | Phase |
|---|---|---|
|
Cancer Cachexia |
Drug: RC-1291 HCl |
Phase 2 |
| Study Type: | Interventional |
| Study Design: | Allocation: Randomized Endpoint Classification: Safety/Efficacy Study Intervention Model: Parallel Assignment Masking: Double-Blind |
Resource links provided by NLM:
Further study details as provided by Helsinn Therapeutics (U.S.), Inc:
Eligibility| Ages Eligible for Study: | 18 Years and older |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
Criteria
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.
Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00267358
Locations
| United States, Arizona | |
| Palo Verde Hematology Oncology Ltd. | |
| Glendale, Arizona, United States, 85304 | |
| United States, California | |
| Comprehensive Blood & Cancer Center | |
| Bakersfield, California, United States, 93309 | |
| Pacific Oncology and Hematology Associates | |
| Encinitas, California, United States, 92024 | |
| Pacific Oncology & Hematology Associates | |
| Encinitas, California, United States, 92024 | |
| Advanced Medical Research Institute | |
| Fresno, California, United States, 93710 | |
| Kenmar Research Institute | |
| Los Angeles, California, United States, 90057 | |
| Kenmar Clinical Research | |
| Los Angeles, California, United States, 90057 | |
| Sant Chawla, Inc. | |
| Santa Monica, California, United States, 90403 | |
| United States, Florida | |
| PAB Clinical Research | |
| Brandon, Florida, United States, 33511 | |
| Osler Medical, Inc./ Osler Clinical Research | |
| Melbourne, Florida, United States, 32901 | |
| Melbourne Internal Medicine Associates | |
| Melbourne, Florida, United States, 32901 | |
| Bay Area Oncology | |
| Tampa, Florida, United States, 33607 | |
| United States, Maryland | |
| Center for Cancer and Blood Disorders | |
| Bethesda, Maryland, United States, 20817 | |
| United States, Ohio | |
| Hematology Oncology Consultants, Inc. | |
| Columbus, Ohio, United States, 43235 | |
| United States, South Carolina | |
| Charleston Cancer Center | |
| Charleston, South Carolina, United States, 29406 | |
| South Carolina Oncology Associates | |
| Columbia, South Carolina, United States, 29210 | |
| South Carolina Cancer Specialists | |
| Hilton Head Island, South Carolina, United States, 29926 | |
| United States, Texas | |
| University of Texas Medical Texas | |
| Galveston, Texas, United States, 77555 | |
| United States, Washington | |
| Multicare Health System | |
| Tacoma, Washington, United States, 98405 | |
Sponsors and Collaborators
Helsinn Therapeutics (U.S.), Inc
Investigators
| Study Director: | William Polvino, MD | Helsinn Therapeutics (U.S.), Inc |
More Information
No publications provided
| ClinicalTrials.gov Identifier: | NCT00267358 History of Changes |
| Other Study ID Numbers: | RC-1291-205 |
| Study First Received: | December 19, 2005 |
| Last Updated: | June 30, 2009 |
| Health Authority: | United States: Food and Drug Administration |
Additional relevant MeSH terms:
|
Cachexia Emaciation Weight Loss |
Body Weight Changes Body Weight Signs and Symptoms |
ClinicalTrials.gov processed this record on May 16, 2013