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Safety and Efficacy of RC-1291 HCl in Patients With Cancer Related Anorexia and Weight Loss

NCT ID: NCT00219817

Last Updated: 2013-09-02

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE2

Total Enrollment

80 participants

Study Classification

INTERVENTIONAL

Study Start Date

2005-06-30

Study Completion Date

2006-10-31

Brief Summary

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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.

Detailed Description

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Conditions

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Cancer Cachexia

Keywords

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Anorexia Cachexia

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

DOUBLE

Interventions

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RC-1291 HCl

Intervention Type DRUG

Eligibility Criteria

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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.
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Helsinn Therapeutics (U.S.), Inc

INDUSTRY

Sponsor Role lead

Principal Investigators

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William Polvino, MD

Role: STUDY_DIRECTOR

Sapphire Therapeutics

Locations

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California Cancer Care Center

Greenbrae, California, United States

Site Status

Massachusetts General Hospital

Boston, Massachusetts, United States

Site Status

Columbia University Medical Center

New York, New York, United States

Site Status

University of Texas Medical Branch at Galveston

Galveston, Texas, United States

Site Status

Michael E. DeBakey Veterans Affairs Medical Center

Houston, Texas, United States

Site Status

Fletcher Allen Health Care

Burlington, Vermont, United States

Site Status

Cancer Outreach Associates

Abingdon, Virginia, United States

Site Status

Countries

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United States

References

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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.

Reference Type DERIVED
PMID: 25524795 (View on PubMed)

Other Identifiers

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RC-1291-203

Identifier Type: -

Identifier Source: org_study_id