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

Primary Purpose

Cancer Cachexia

Status
Completed
Phase
Phase 2
Locations
United States
Study Type
Interventional
Intervention
RC-1291 HCl
Sponsored by
Helsinn Therapeutics (U.S.), Inc
About
Eligibility
Locations
Outcomes
Full info

About this trial

This is an interventional treatment trial for Cancer Cachexia focused on measuring Anorexia, Cachexia

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

  • California Cancer Care Center
  • Massachusetts General Hospital
  • Columbia University Medical Center
  • University of Texas Medical Branch at Galveston
  • Michael E. DeBakey Veterans Affairs Medical Center
  • Fletcher Allen Health Care
  • Cancer Outreach Associates

Outcomes

Primary Outcome Measures

Body Weight
Lean Body Mass
Functional Performance

Secondary Outcome Measures

Full Information

First Posted
September 12, 2005
Last Updated
August 30, 2013
Sponsor
Helsinn Therapeutics (U.S.), Inc
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1. Study Identification

Unique Protocol Identification Number
NCT00219817
Brief Title
Safety and Efficacy of RC-1291 HCl in Patients With Cancer Related Anorexia and Weight Loss
Study Type
Interventional

2. Study Status

Record Verification Date
August 2013
Overall Recruitment Status
Completed
Study Start Date
June 2005 (undefined)
Primary Completion Date
October 2006 (Actual)
Study Completion Date
October 2006 (Actual)

3. Sponsor/Collaborators

Name of the Sponsor
Helsinn Therapeutics (U.S.), Inc

4. Oversight

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Cancer Cachexia
Keywords
Anorexia, Cachexia

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Parallel Assignment
Masking
Double
Allocation
Randomized
Enrollment
80 (false)

8. Arms, Groups, and Interventions

Intervention Type
Drug
Intervention Name(s)
RC-1291 HCl
Primary Outcome Measure Information:
Title
Body Weight
Title
Lean Body Mass
Title
Functional Performance

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
William Polvino, MD
Organizational Affiliation
Sapphire Therapeutics
Official's Role
Study Director
Facility Information:
Facility Name
California Cancer Care Center
City
Greenbrae
State/Province
California
ZIP/Postal Code
94904
Country
United States
Facility Name
Massachusetts General Hospital
City
Boston
State/Province
Massachusetts
ZIP/Postal Code
02114
Country
United States
Facility Name
Columbia University Medical Center
City
New York
State/Province
New York
ZIP/Postal Code
10032
Country
United States
Facility Name
University of Texas Medical Branch at Galveston
City
Galveston
State/Province
Texas
ZIP/Postal Code
77555
Country
United States
Facility Name
Michael E. DeBakey Veterans Affairs Medical Center
City
Houston
State/Province
Texas
ZIP/Postal Code
77030
Country
United States
Facility Name
Fletcher Allen Health Care
City
Burlington
State/Province
Vermont
ZIP/Postal Code
05401
Country
United States
Facility Name
Cancer Outreach Associates
City
Abingdon
State/Province
Virginia
ZIP/Postal Code
24211
Country
United States

12. IPD Sharing Statement

Citations:
PubMed Identifier
25524795
Citation
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.
Results Reference
derived

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

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