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

Primary Purpose

Cancer Cachexia

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

About this trial

This is an interventional treatment trial for Cancer Cachexia

Eligibility Criteria

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

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.

Sites / Locations

  • Palo Verde Hematology Oncology, Ltd.
  • San Diego Pacific Oncology & Hematology Associates
  • Sant P. Chawla, MD
  • Melbourne Internal Medicine Associates
  • Southwest Oncology Associates
  • Center for Cancer and Blood Disorders
  • Chesapeake Oncology Hematology Associates, PA
  • Beth Israel Cancer Center
  • Charleston Cancer Center
  • South Carolina Oncology Associates, PA
  • South Carolina Cancer Specialists
  • University of Texas Medical Branch
  • Michael E. DeBakey VA Medical Center
  • Cancer Outreach Associates
  • Virginia Cancer Institute
  • Multicare Health System
  • Northwest Medical Specialties

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm Type

Placebo Comparator

Experimental

Experimental

Arm Label

1

2

3

Arm Description

RC-1291 50mg

RC-1291 100mg

Outcomes

Primary Outcome Measures

Body weight; Lean body mass; Functional performance

Secondary Outcome Measures

Full Information

First Posted
September 18, 2006
Last Updated
August 30, 2013
Sponsor
Helsinn Therapeutics (U.S.), Inc
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1. Study Identification

Unique Protocol Identification Number
NCT00378131
Brief Title
Placebo Controlled, Randomized Safety and Efficacy Study of RC-1291 in Cancer Anorexia/Cachexia
Official Title
A 12-Week, Double-Blind, Randomized, Placebo-Controlled, Parallel Group Phase II Study Comparing the Safety, Tolerability and Beneficial Effects of Daily Doses of RC-1291 and Placebo in Patients With Cancer Anorexia/Cachexia
Study Type
Interventional

2. Study Status

Record Verification Date
August 2013
Overall Recruitment Status
Completed
Study Start Date
September 2006 (undefined)
Primary Completion Date
April 2007 (Actual)
Study Completion Date
April 2007 (Actual)

3. Sponsor/Collaborators

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

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

Brief Summary
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
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.

6. Conditions and Keywords

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

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderInvestigator
Allocation
Randomized
Enrollment
51 (Actual)

8. Arms, Groups, and Interventions

Arm Title
1
Arm Type
Placebo Comparator
Arm Title
2
Arm Type
Experimental
Arm Description
RC-1291 50mg
Arm Title
3
Arm Type
Experimental
Arm Description
RC-1291 100mg
Intervention Type
Drug
Intervention Name(s)
RC-1291
Intervention Type
Drug
Intervention Name(s)
placebo
Primary Outcome Measure Information:
Title
Body weight; Lean body mass; Functional performance
Time Frame
4 weeks

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
William Polvino, MD
Organizational Affiliation
Helsinn Therapeutics (U.S.), Inc
Official's Role
Study Director
Facility Information:
Facility Name
Palo Verde Hematology Oncology, Ltd.
City
Glendale
State/Province
Arizona
ZIP/Postal Code
85304
Country
United States
Facility Name
San Diego Pacific Oncology & Hematology Associates
City
Encinitas
State/Province
California
ZIP/Postal Code
92024
Country
United States
Facility Name
Sant P. Chawla, MD
City
Santa Monica
State/Province
California
ZIP/Postal Code
90403
Country
United States
Facility Name
Melbourne Internal Medicine Associates
City
Melbourne
State/Province
Florida
ZIP/Postal Code
32901
Country
United States
Facility Name
Southwest Oncology Associates
City
Lafayette
State/Province
Louisiana
ZIP/Postal Code
70503
Country
United States
Facility Name
Center for Cancer and Blood Disorders
City
Bethesda
State/Province
Maryland
ZIP/Postal Code
20817
Country
United States
Facility Name
Chesapeake Oncology Hematology Associates, PA
City
Glen Burnie
State/Province
Maryland
ZIP/Postal Code
21061
Country
United States
Facility Name
Beth Israel Cancer Center
City
New York
State/Province
New York
ZIP/Postal Code
10003
Country
United States
Facility Name
Charleston Cancer Center
City
Charleston
State/Province
South Carolina
ZIP/Postal Code
29406
Country
United States
Facility Name
South Carolina Oncology Associates, PA
City
Columbia
State/Province
South Carolina
ZIP/Postal Code
29210
Country
United States
Facility Name
South Carolina Cancer Specialists
City
Hilton Head Island
State/Province
South Carolina
ZIP/Postal Code
29926
Country
United States
Facility Name
University of Texas Medical Branch
City
Galveston
State/Province
Texas
ZIP/Postal Code
77555
Country
United States
Facility Name
Michael E. DeBakey VA Medical Center
City
Houston
State/Province
Texas
ZIP/Postal Code
77030
Country
United States
Facility Name
Cancer Outreach Associates
City
Abingdon
State/Province
Virginia
ZIP/Postal Code
24211
Country
United States
Facility Name
Virginia Cancer Institute
City
Richmond
State/Province
Virginia
ZIP/Postal Code
23230
Country
United States
Facility Name
Multicare Health System
City
Tacoma
State/Province
Washington
ZIP/Postal Code
98405
Country
United States
Facility Name
Northwest Medical Specialties
City
Tacoma
State/Province
Washington
ZIP/Postal Code
98405
Country
United States

12. IPD Sharing Statement

Learn more about this trial

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

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