NCT00267358

Brief Summary

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Timeline
Completed

Started Nov 2005

Shorter than P25 for phase_2

Geographic Reach
1 country

19 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

November 1, 2005

Completed
2 months until next milestone

First Submitted

Initial submission to the registry

December 19, 2005

Completed
1 day until next milestone

First Posted

Study publicly available on registry

December 20, 2005

Completed
10 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

October 1, 2006

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

October 1, 2006

Completed
Last Updated

September 2, 2013

Status Verified

August 1, 2013

Enrollment Period

11 months

First QC Date

December 19, 2005

Last Update Submit

August 30, 2013

Conditions

Cancer Cachexia

Outcome Measures

Primary Outcomes (3)

  • Body weight

  • Lean body mass

  • Functional performance

Study Arms (2)

RC-1291 HCl

ACTIVE COMPARATOR

50 mg

Drug: RC-1291 HCl

Placebo

PLACEBO COMPARATOR
Drug: Placebo

Interventions

RC-1291 HClDRUG
RC-1291 HCl
PlaceboDRUG
Placebo

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Community-dwelling patients ≥ 18 years of age with incurable,histologically diagnosed cancer.
  • Involuntary loss of body weight of ≥ 5 % within the past 6 months

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (19)

Palo Verde Hematology Oncology Ltd.

Glendale, Arizona, 85304, United States

Location

Comprehensive Blood & Cancer Center

Bakersfield, California, 93309, United States

Location

Pacific Oncology & Hematology Associates

Encinitas, California, 92024, United States

Location

Pacific Oncology and Hematology Associates

Encinitas, California, 92024, United States

Location

Advanced Medical Research Institute

Fresno, California, 93710, United States

Location

Kenmar Clinical Research

Los Angeles, California, 90057, United States

Location

Kenmar Research Institute

Los Angeles, California, 90057, United States

Location

Sant Chawla, Inc.

Santa Monica, California, 90403, United States

Location

PAB Clinical Research

Brandon, Florida, 33511, United States

Location

Melbourne Internal Medicine Associates

Melbourne, Florida, 32901, United States

Location

Osler Medical, Inc./ Osler Clinical Research

Melbourne, Florida, 32901, United States

Location

Bay Area Oncology

Tampa, Florida, 33607, United States

Location

Center for Cancer and Blood Disorders

Bethesda, Maryland, 20817, United States

Location

Hematology Oncology Consultants, Inc.

Columbus, Ohio, 43235, United States

Location

Charleston Cancer Center

Charleston, South Carolina, 29406, United States

Location

South Carolina Oncology Associates

Columbia, South Carolina, 29210, United States

Location

South Carolina Cancer Specialists

Hilton Head Island, South Carolina, 29926, United States

Location

University of Texas Medical Texas

Galveston, Texas, 77555, United States

Location

Multicare Health System

Tacoma, Washington, 98405, United States

Location

Related Publications (1)

  • 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.

    PMID: 25524795DERIVED

Study Officials

  • William Polvino, MD

    Helsinn Therapeutics (U.S.), Inc

    STUDY DIRECTOR

Study Design

Study Type
interventional
Phase
phase 2
Allocation
RANDOMIZED
Masking
DOUBLE
Intervention Model
PARALLEL
Sponsor Type
INDUSTRY

Study Record Dates

First Submitted

December 19, 2005

First Posted

December 20, 2005

Study Start

November 1, 2005

Primary Completion

October 1, 2006

Study Completion

October 1, 2006

Last Updated

September 2, 2013

Record last verified: 2013-08

Locations

US(19)