NCT00378131

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.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
51

participants targeted

Target at P25-P50 for phase_2

Timeline
Completed

Started Sep 2006

Shorter than P25 for phase_2

Geographic Reach
1 country

17 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

September 1, 2006

Completed
17 days until next milestone

First Submitted

Initial submission to the registry

September 18, 2006

Completed
1 day until next milestone

First Posted

Study publicly available on registry

September 19, 2006

Completed
6 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

April 1, 2007

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

April 1, 2007

Completed
Last Updated

September 2, 2013

Status Verified

August 1, 2013

Enrollment Period

7 months

First QC Date

September 18, 2006

Last Update Submit

August 30, 2013

Conditions

Cancer Cachexia

Outcome Measures

Primary Outcomes (1)

  • Body weight; Lean body mass; Functional performance

    4 weeks

Study Arms (3)

1

PLACEBO COMPARATOR
Drug: placebo

2

EXPERIMENTAL

RC-1291 50mg

Drug: RC-1291

3

EXPERIMENTAL

RC-1291 100mg

Drug: RC-1291

Interventions

RC-1291DRUG
23
placeboDRUG
1

Eligibility Criteria

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

You may qualify if:

  • 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

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 (17)

Palo Verde Hematology Oncology, Ltd.

Glendale, Arizona, 85304, United States

Location

San Diego Pacific Oncology & Hematology Associates

Encinitas, California, 92024, United States

Location

Sant P. Chawla, MD

Santa Monica, California, 90403, United States

Location

Melbourne Internal Medicine Associates

Melbourne, Florida, 32901, United States

Location

Southwest Oncology Associates

Lafayette, Louisiana, 70503, United States

Location

Center for Cancer and Blood Disorders

Bethesda, Maryland, 20817, United States

Location

Chesapeake Oncology Hematology Associates, PA

Glen Burnie, Maryland, 21061, United States

Location

Beth Israel Cancer Center

New York, New York, 10003, United States

Location

Charleston Cancer Center

Charleston, South Carolina, 29406, United States

Location

South Carolina Oncology Associates, PA

Columbia, South Carolina, 29210, United States

Location

South Carolina Cancer Specialists

Hilton Head Island, South Carolina, 29926, United States

Location

University of Texas Medical Branch

Galveston, Texas, 77555, United States

Location

Michael E. DeBakey VA Medical Center

Houston, Texas, 77030, United States

Location

Cancer Outreach Associates

Abingdon, Virginia, 24211, United States

Location

Virginia Cancer Institute

Richmond, Virginia, 23230, United States

Location

Multicare Health System

Tacoma, Washington, 98405, United States

Location

Northwest Medical Specialties

Tacoma, Washington, 98405, United States

Location

MeSH Terms

Interventions

RC-1291

Study Officials

  • William Polvino, MD

    Helsinn Therapeutics (U.S.), Inc

    STUDY DIRECTOR

Study Design

Study Type
interventional
Phase
phase 2
Allocation
RANDOMIZED
Masking
TRIPLE
Who Masked
PARTICIPANT, CARE PROVIDER, INVESTIGATOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
INDUSTRY

Study Record Dates

First Submitted

September 18, 2006

First Posted

September 19, 2006

Study Start

September 1, 2006

Primary Completion

April 1, 2007

Study Completion

April 1, 2007

Last Updated

September 2, 2013

Record last verified: 2013-08

Locations

US(17)