Clinical trial NCT00267358: Placebo Controlled, Randomized Safety and Efficacy Study of RC-1291 in Cancer Anorexia/Cachexia.
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Cancer Cachexia
Lead sponsor: Helsinn Therapeutics (U.S.), Inc
Sponsor class: INDUSTRY
First posted: 2005-12-20
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL

Brief summary: 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.


Eligibility 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.

Primary outcomes:
measure: Body weight
measure: Lean body mass
measure: Functional performance
Secondary outcomes:
Other outcomes:
Locations:
city: Glendale
country: United States
facility: Palo Verde Hematology Oncology Ltd.
state: Arizona
city: Bakersfield
country: United States
facility: Comprehensive Blood & Cancer Center
state: California
city: Encinitas
country: United States
facility: Pacific Oncology & Hematology Associates
state: California
city: Encinitas
country: United States
facility: Pacific Oncology and Hematology Associates
state: California
city: Fresno
country: United States
facility: Advanced Medical Research Institute
state: California
city: Los Angeles
country: United States
facility: Kenmar Clinical Research
state: California
city: Los Angeles
country: United States
facility: Kenmar Research Institute
state: California
city: Santa Monica
country: United States
facility: Sant Chawla, Inc.
state: California
city: Brandon
country: United States
facility: PAB Clinical Research
state: Florida
city: Melbourne
country: United States
facility: Melbourne Internal Medicine Associates
state: Florida
city: Melbourne
country: United States
facility: Osler Medical, Inc./ Osler Clinical Research
state: Florida
city: Tampa
country: United States
facility: Bay Area Oncology
state: Florida
city: Bethesda
country: United States
facility: Center for Cancer and Blood Disorders
state: Maryland
city: Columbus
country: United States
facility: Hematology Oncology Consultants, Inc.
state: Ohio
city: Charleston
country: United States
facility: Charleston Cancer Center
state: South Carolina
city: Columbia
country: United States
facility: South Carolina Oncology Associates
state: South Carolina
city: Hilton Head Island
country: United States
facility: South Carolina Cancer Specialists
state: South Carolina
city: Galveston
country: United States
facility: University of Texas Medical Texas
state: Texas
city: Tacoma
country: United States
facility: Multicare Health System
state: Washington
Study officials:
affiliation: Helsinn Therapeutics (U.S.), Inc
name: William Polvino, MD
role: STUDY_DIRECTOR
References:
citation: 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.