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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 |
|---|---|---|---|
| RC-1291 HCl | Active Comparator | 50 mg |
|
| Placebo | Placebo Comparator |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| RC-1291 HCl | Drug |
| ||
| Placebo |
| Measure | Description | Time Frame |
|---|---|---|
| Body weight | ||
| Lean body mass | ||
| Functional performance |
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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 | ||
| Comprehensive Blood & Cancer Center |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 25524795 | Derived | Garcia JM, Boccia RV, Graham CD, Yan Y, Duus EM, Allen S, Friend J. Anamorelin for patients with cancer cachexia: an integrated analysis of two phase 2, randomised, placebo-controlled, double-blind trials. Lancet Oncol. 2015 Jan;16(1):108-16. doi: 10.1016/S1470-2045(14)71154-4. Epub 2014 Dec 16. |
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|
| Bakersfield |
| California |
| 93309 |
| United States |
| Pacific Oncology & Hematology Associates | Encinitas | California | 92024 | United States |
| Pacific Oncology and Hematology Associates | Encinitas | California | 92024 | United States |
| Advanced Medical Research Institute | Fresno | California | 93710 | United States |
| Kenmar Clinical Research | Los Angeles | California | 90057 | United States |
| Kenmar Research Institute | Los Angeles | California | 90057 | United States |
| Sant Chawla, Inc. | Santa Monica | California | 90403 | United States |
| PAB Clinical Research | Brandon | Florida | 33511 | United States |
| Melbourne Internal Medicine Associates | Melbourne | Florida | 32901 | United States |
| Osler Medical, Inc./ Osler Clinical Research | Melbourne | Florida | 32901 | United States |
| Bay Area Oncology | Tampa | Florida | 33607 | United States |
| Center for Cancer and Blood Disorders | Bethesda | Maryland | 20817 | United States |
| Hematology Oncology Consultants, Inc. | Columbus | Ohio | 43235 | United States |
| Charleston Cancer Center | Charleston | South Carolina | 29406 | United States |
| South Carolina Oncology Associates | Columbia | South Carolina | 29210 | United States |
| South Carolina Cancer Specialists | Hilton Head Island | South Carolina | 29926 | United States |
| University of Texas Medical Texas | Galveston | Texas | 77555 | United States |
| Multicare Health System | Tacoma | Washington | 98405 | United States |