Safety and Efficacy of RC-1291 HCl in Patients With Cancer Related Anorexia and Weight Loss
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ClinicalTrials.gov Identifier: NCT00219817 |
Recruitment Status :
Completed
First Posted : September 22, 2005
Last Update Posted : September 2, 2013
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Condition or disease | Intervention/treatment | Phase |
---|---|---|
Cancer Cachexia | Drug: RC-1291 HCl | Phase 2 |
Study Type : | Interventional (Clinical Trial) |
Enrollment : | 80 participants |
Allocation: | Randomized |
Intervention Model: | Parallel Assignment |
Masking: | Double |
Primary Purpose: | Treatment |
Study Start Date : | June 2005 |
Actual Primary Completion Date : | October 2006 |
Actual Study Completion Date : | October 2006 |
- Body Weight
- Lean Body Mass
- Functional Performance
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.
Ages Eligible for Study: | 18 Years and older (Adult, Older Adult) |
Sexes Eligible for Study: | All |
Accepts Healthy Volunteers: | No |
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.
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00219817
United States, California | |
California Cancer Care Center | |
Greenbrae, California, United States, 94904 | |
United States, Massachusetts | |
Massachusetts General Hospital | |
Boston, Massachusetts, United States, 02114 | |
United States, New York | |
Columbia University Medical Center | |
New York, New York, United States, 10032 | |
United States, Texas | |
University of Texas Medical Branch at Galveston | |
Galveston, Texas, United States, 77555 | |
Michael E. DeBakey Veterans Affairs Medical Center | |
Houston, Texas, United States, 77030 | |
United States, Vermont | |
Fletcher Allen Health Care | |
Burlington, Vermont, United States, 05401 | |
United States, Virginia | |
Cancer Outreach Associates | |
Abingdon, Virginia, United States, 24211 |
Study Director: | William Polvino, MD | Sapphire Therapeutics |
ClinicalTrials.gov Identifier: | NCT00219817 |
Other Study ID Numbers: |
RC-1291-203 |
First Posted: | September 22, 2005 Key Record Dates |
Last Update Posted: | September 2, 2013 |
Last Verified: | August 2013 |
Anorexia Cachexia |
Wasting Syndrome Cachexia Weight Loss Body Weight Changes |
Body Weight Thinness Metabolic Diseases Nutrition Disorders |