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
18 Years
N/A
Both
Cancer Cachexia
Trial Information
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
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.
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.
Type of Study:
Interventional
Study Design:
Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator), Primary Purpose: Treatment
Outcome Measure:
Body weight; Lean body mass; Functional performance
Outcome Time Frame:
4 weeks
Safety Issue:
No
Principal Investigator
William Polvino, MD
Investigator Role:
Study Director
Investigator Affiliation:
Helsinn Therapeutics (U.S.), Inc
Authority:
United States: Food and Drug Administration
Study ID:
RC-1291-206
NCT ID:
NCT00378131
Start Date:
September 2006
Completion Date:
April 2007
Related Keywords:
- Cancer Cachexia
- Anorexia
- Cachexia
Name | Location |
|---|---|
| University of Texas Medical Branch | Galveston, Texas 77555-1329 |
| South Carolina Oncology Associates, PA | Columbia, South Carolina 29210 |
| Charleston Cancer Center | Charleston, South Carolina 29406 |
| Virginia Cancer Institute | Richmond, Virginia 23230 |
| Beth Israel Cancer Center | New York, New York 10003 |
| Southwest Oncology Associates | Lafayette, Louisiana 70503 |
| Northwest Medical Specialties | Tacoma, Washington 98405 |
| Center for Cancer and Blood Disorders | Bethesda, Maryland 20817 |
| Multicare Health System | Tacoma, Washington 98415 |
| South Carolina Cancer Specialists | Hilton Head Island, South Carolina 29925 |
| Cancer Outreach Associates | Abingdon, Virginia 24211 |
| Melbourne Internal Medicine Associates | Melbourne, Florida 32901 |
| Palo Verde Hematology Oncology, Ltd. | Glendale, Arizona 85304 |
| San Diego Pacific Oncology & Hematology Associates | Encinitas, California 92024 |
| Sant P. Chawla, MD | Santa Monica, California 90403 |
| Chesapeake Oncology Hematology Associates, PA | Glen Burnie, Maryland 21061 |
| Michael E. DeBakey VA Medical Center | Houston, Texas 77030 |
