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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


Phase 2
18 Years
N/A
Not Enrolling
Both
Cancer Cachexia

Thank you

Trial Information

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


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 virture 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.


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.

Type of Study:

Interventional

Study Design:

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator), Primary Purpose: Treatment

Outcome Measure:

Body weight; Lean body mass; Functional performance

Outcome Time Frame:

4 weeks

Safety Issue:

No

Principal Investigator

William Polvino, MD

Investigator Role:

Study Director

Investigator Affiliation:

Helsinn Therapeutics (U.S.), Inc

Authority:

United States: Food and Drug Administration

Study ID:

RC-1291-206

NCT ID:

NCT00378131

Start Date:

September 2006

Completion Date:

April 2007

Related Keywords:

  • Cancer Cachexia
  • Anorexia
  • Cachexia

Name

Location

University of Texas Medical BranchGalveston, Texas  77555-1329
South Carolina Oncology Associates, PAColumbia, South Carolina  29210
Charleston Cancer CenterCharleston, South Carolina  29406
Virginia Cancer InstituteRichmond, Virginia  23230
Beth Israel Cancer CenterNew York, New York  10003
Southwest Oncology AssociatesLafayette, Louisiana  70503
Northwest Medical SpecialtiesTacoma, Washington  98405
Center for Cancer and Blood DisordersBethesda, Maryland  20817
Multicare Health SystemTacoma, Washington  98415
South Carolina Cancer SpecialistsHilton Head Island, South Carolina  29925
Cancer Outreach AssociatesAbingdon, Virginia  24211
Melbourne Internal Medicine AssociatesMelbourne, Florida  32901
Palo Verde Hematology Oncology, Ltd.Glendale, Arizona  85304
San Diego Pacific Oncology & Hematology AssociatesEncinitas, California  92024
Sant P. Chawla, MDSanta Monica, California  90403
Chesapeake Oncology Hematology Associates, PAGlen Burnie, Maryland  21061
Michael E. DeBakey VA Medical CenterHouston, Texas  77030