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Placebo Controlled, Randomized Safety and Efficacy Study of RC-1291 in Cancer Anorexia/Cachexia.

NCT ID: NCT00267358

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

Study Classification

INTERVENTIONAL

Study Start Date

2005-11-30

Study Completion Date

2006-10-31

Brief Summary

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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.

Detailed Description

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Conditions

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Cancer Cachexia

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Blinding Strategy

DOUBLE

Study Groups

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RC-1291 HCl

50 mg

Group Type ACTIVE_COMPARATOR

RC-1291 HCl

Intervention Type DRUG

Placebo

Group Type PLACEBO_COMPARATOR

Placebo

Intervention Type DRUG

Interventions

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RC-1291 HCl

Intervention Type DRUG

Placebo

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

Helsinn Therapeutics (U.S.), Inc

Locations

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Palo Verde Hematology Oncology Ltd.

Glendale, Arizona, United States

Site Status

Comprehensive Blood & Cancer Center

Bakersfield, California, United States

Site Status

Pacific Oncology & Hematology Associates

Encinitas, California, United States

Site Status

Pacific Oncology and Hematology Associates

Encinitas, California, United States

Site Status

Advanced Medical Research Institute

Fresno, California, United States

Site Status

Kenmar Clinical Research

Los Angeles, California, United States

Site Status

Kenmar Research Institute

Los Angeles, California, United States

Site Status

Sant Chawla, Inc.

Santa Monica, California, United States

Site Status

PAB Clinical Research

Brandon, Florida, United States

Site Status

Melbourne Internal Medicine Associates

Melbourne, Florida, United States

Site Status

Osler Medical, Inc./ Osler Clinical Research

Melbourne, Florida, United States

Site Status

Bay Area Oncology

Tampa, Florida, United States

Site Status

Center for Cancer and Blood Disorders

Bethesda, Maryland, United States

Site Status

Hematology Oncology Consultants, Inc.

Columbus, Ohio, United States

Site Status

Charleston Cancer Center

Charleston, South Carolina, United States

Site Status

South Carolina Oncology Associates

Columbia, South Carolina, United States

Site Status

South Carolina Cancer Specialists

Hilton Head Island, South Carolina, United States

Site Status

University of Texas Medical Texas

Galveston, Texas, United States

Site Status

Multicare Health System

Tacoma, Washington, 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-1291-205

Identifier Type: -

Identifier Source: org_study_id