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:
NCT00378131
First received: September 18, 2006
Last updated: June 30, 2009
Last verified: June 2009
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Purpose
Activation of Ghrelin receptors have been demonstrated to stimulate appetite. RC-1291 HCl, by virture 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.
| Condition | Intervention | Phase |
|---|---|---|
|
Cancer Cachexia |
Drug: RC-1291 Drug: placebo |
Phase 2 |
| Study Type: | Interventional |
| Study Design: | Allocation: Randomized Endpoint Classification: Safety/Efficacy Study Intervention Model: Parallel Assignment Masking: Double Blind (Subject, Caregiver, Investigator) Primary Purpose: Treatment |
| Official Title: | A 12-Week, Double-Blind, Randomized, Placebo-Controlled, Parallel Group Phase II Study Comparing the Safety, Tolerability and Beneficial Effects of Daily Doses of RC-1291 and Placebo in Patients With Cancer Anorexia/Cachexia |
Resource links provided by NLM:
Further study details as provided by Helsinn Therapeutics (U.S.), Inc:
Primary Outcome Measures:
- Body weight; Lean body mass; Functional performance [ Time Frame: 4 weeks ] [ Designated as safety issue: No ]
| Enrollment: | 51 |
| Study Start Date: | September 2006 |
| Study Completion Date: | April 2007 |
| Primary Completion Date: | April 2007 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
| Placebo Comparator: 1 |
Drug: placebo
placebo
Other Name: placebo
|
|
Experimental: 2
RC-1291
|
Drug: RC-1291
50 mg
Other Name: RC-1291
|
|
Experimental: 3
RC-1291
|
Drug: RC-1291
50 mg
Other Name: RC-1291
|
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 stimulate appetite. RC-1291 HCl, by virture 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.
Eligibility| Ages Eligible for Study: | 18 Years and older |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
Criteria
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.
Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00378131
Locations
| United States, Arizona | |
| Palo Verde Hematology Oncology, Ltd. | |
| Glendale, Arizona, United States, 85304 | |
| United States, California | |
| San Diego Pacific Oncology & Hematology Associates | |
| Encinitas, California, United States, 92024 | |
| Sant P. Chawla, MD | |
| Santa Monica, California, United States, 90403 | |
| United States, Florida | |
| Melbourne Internal Medicine Associates | |
| Melbourne, Florida, United States, 32901 | |
| United States, Louisiana | |
| Southwest Oncology Associates | |
| Lafayette, Louisiana, United States, 70503 | |
| United States, Maryland | |
| Center for Cancer and Blood Disorders | |
| Bethesda, Maryland, United States, 20817 | |
| Chesapeake Oncology Hematology Associates, PA | |
| Glen Burnie, Maryland, United States, 21061 | |
| United States, New York | |
| Beth Israel Cancer Center | |
| New York, New York, United States, 10003 | |
| United States, South Carolina | |
| Charleston Cancer Center | |
| Charleston, South Carolina, United States, 29406 | |
| South Carolina Oncology Associates, PA | |
| 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 Branch | |
| Galveston, Texas, United States, 77555 | |
| Michael E. DeBakey VA Medical Center | |
| Houston, Texas, United States, 77030 | |
| United States, Virginia | |
| Cancer Outreach Associates | |
| Abingdon, Virginia, United States, 24211 | |
| Virginia Cancer Institute | |
| Richmond, Virginia, United States, 23230 | |
| United States, Washington | |
| Multicare Health System | |
| Tacoma, Washington, United States, 98405 | |
| Northwest Medical Specialties | |
| 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: | NCT00378131 History of Changes |
| Other Study ID Numbers: | RC-1291-206 |
| Study First Received: | September 18, 2006 |
| Last Updated: | June 30, 2009 |
| Health Authority: | United States: Food and Drug Administration |
Additional relevant MeSH terms:
|
Anorexia Cachexia Signs and Symptoms, Digestive Signs and Symptoms |
Emaciation Weight Loss Body Weight Changes Body Weight |
ClinicalTrials.gov processed this record on June 18, 2013