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

NCT ID: NCT00378131

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

51 participants

Study Classification

INTERVENTIONAL

Study Start Date

2006-09-30

Study Completion Date

2007-04-30

Brief Summary

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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 cachexia.

Detailed Description

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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.

Conditions

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Cancer Cachexia

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

TRIPLE

Participants Caregivers Investigators

Study Groups

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1

Group Type PLACEBO_COMPARATOR

placebo

Intervention Type DRUG

2

RC-1291 50mg

Group Type EXPERIMENTAL

RC-1291

Intervention Type DRUG

3

RC-1291 100mg

Group Type EXPERIMENTAL

RC-1291

Intervention Type DRUG

Interventions

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RC-1291

Intervention Type DRUG

placebo

Intervention Type DRUG

Eligibility Criteria

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Inclusion Criteria

* Community-dwelling patients greater than 18 years of age with incurable, histologically diagnosed cancer.
* Involuntary loss of body weight greater than 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

San Diego Pacific Oncology & Hematology Associates

Encinitas, California, United States

Site Status

Sant P. Chawla, MD

Santa Monica, California, United States

Site Status

Melbourne Internal Medicine Associates

Melbourne, Florida, United States

Site Status

Southwest Oncology Associates

Lafayette, Louisiana, United States

Site Status

Center for Cancer and Blood Disorders

Bethesda, Maryland, United States

Site Status

Chesapeake Oncology Hematology Associates, PA

Glen Burnie, Maryland, United States

Site Status

Beth Israel Cancer Center

New York, New York, United States

Site Status

Charleston Cancer Center

Charleston, South Carolina, United States

Site Status

South Carolina Oncology Associates, PA

Columbia, South Carolina, United States

Site Status

South Carolina Cancer Specialists

Hilton Head Island, South Carolina, United States

Site Status

University of Texas Medical Branch

Galveston, Texas, United States

Site Status

Michael E. DeBakey VA Medical Center

Houston, Texas, United States

Site Status

Cancer Outreach Associates

Abingdon, Virginia, United States

Site Status

Virginia Cancer Institute

Richmond, Virginia, United States

Site Status

Multicare Health System

Tacoma, Washington, United States

Site Status

Northwest Medical Specialties

Tacoma, Washington, United States

Site Status

Countries

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United States

Other Identifiers

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RC-1291-206

Identifier Type: -

Identifier Source: org_study_id