Safety and Efficacy of RC-1291 HCl in Patients With Cancer Related Anorexia and Weight Loss
1 other identifier
interventional
80
1 country
7
Brief Summary
Anorexia and weight loss 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 weight loss. This study will test the safety and efficacy of RC-1291 in the treatment of cancer patients with anorexia and weight loss.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for phase_2
Started Jun 2005
Shorter than P25 for phase_2
7 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
June 1, 2005
CompletedFirst Submitted
Initial submission to the registry
September 12, 2005
CompletedFirst Posted
Study publicly available on registry
September 22, 2005
CompletedPrimary Completion
Last participant's last visit for primary outcome
October 1, 2006
CompletedStudy Completion
Last participant's last visit for all outcomes
October 1, 2006
CompletedSeptember 2, 2013
August 1, 2013
1.3 years
September 12, 2005
August 30, 2013
Conditions
Keywords
Outcome Measures
Primary Outcomes (3)
Body Weight
Lean Body Mass
Functional Performance
Interventions
Eligibility Criteria
You may qualify if:
- Community-dwelling patients ≥ 18 years of age with incurable, histologically diagnosed cancer.
- Involuntary loss of body weight of ≥ 5 % within the past 6 months
You may not qualify if:
- 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.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (7)
California Cancer Care Center
Greenbrae, California, 94904, United States
Massachusetts General Hospital
Boston, Massachusetts, 02114, United States
Columbia University Medical Center
New York, New York, 10032, United States
University of Texas Medical Branch at Galveston
Galveston, Texas, 77555, United States
Michael E. DeBakey Veterans Affairs Medical Center
Houston, Texas, 77030, United States
Fletcher Allen Health Care
Burlington, Vermont, 05401, United States
Cancer Outreach Associates
Abingdon, Virginia, 24211, United States
Related Publications (1)
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.
PMID: 25524795DERIVED
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- STUDY DIRECTOR
William Polvino, MD
Sapphire Therapeutics
Study Design
- Study Type
- interventional
- Phase
- phase 2
- Allocation
- RANDOMIZED
- Masking
- DOUBLE
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- INDUSTRY
Study Record Dates
First Submitted
September 12, 2005
First Posted
September 22, 2005
Study Start
June 1, 2005
Primary Completion
October 1, 2006
Study Completion
October 1, 2006
Last Updated
September 2, 2013
Record last verified: 2013-08