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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 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 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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 1 | Placebo Comparator |
| |
| 2 | Experimental | RC-1291 50mg |
|
| 3 | Experimental | RC-1291 100mg |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| RC-1291 | Drug |
| ||
| placebo |
| Measure | Description | Time Frame |
|---|---|---|
| Body weight; Lean body mass; Functional performance | 4 weeks |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| William Polvino, MD | Helsinn Therapeutics (U.S.), Inc | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Palo Verde Hematology Oncology, Ltd. | Glendale | Arizona | 85304 | United States | ||
| San Diego Pacific Oncology & Hematology Associates |
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|
| Encinitas |
| California |
| 92024 |
| United States |
| Sant P. Chawla, MD | Santa Monica | California | 90403 | United States |
| Melbourne Internal Medicine Associates | Melbourne | Florida | 32901 | United States |
| Southwest Oncology Associates | Lafayette | Louisiana | 70503 | United States |
| Center for Cancer and Blood Disorders | Bethesda | Maryland | 20817 | United States |
| Chesapeake Oncology Hematology Associates, PA | Glen Burnie | Maryland | 21061 | United States |
| Beth Israel Cancer Center | New York | New York | 10003 | United States |
| Charleston Cancer Center | Charleston | South Carolina | 29406 | United States |
| South Carolina Oncology Associates, PA | Columbia | South Carolina | 29210 | United States |
| South Carolina Cancer Specialists | Hilton Head Island | South Carolina | 29926 | United States |
| University of Texas Medical Branch | Galveston | Texas | 77555 | United States |
| Michael E. DeBakey VA Medical Center | Houston | Texas | 77030 | United States |
| Cancer Outreach Associates | Abingdon | Virginia | 24211 | United States |
| Virginia Cancer Institute | Richmond | Virginia | 23230 | United States |
| Multicare Health System | Tacoma | Washington | 98405 | United States |
| Northwest Medical Specialties | Tacoma | Washington | 98405 | United States |
| ID | Term |
|---|---|
| C524461 | RC-1291 |
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