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

NCT00378131 — Phase 2, Completed, 51 participants, Helsinn Therapeutics (U.S.), Inc
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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

RegistryNCT00378131
StatusCompleted
PhasePhase 2
Study typeInterventional; randomized, parallel, masking: triple, treatment
Enrollment51 (Actual)
SponsorHelsinn Therapeutics (U.S.), Inc (Industry)
ConditionsCancer Cachexia
InterventionsRC-1291, placebo (Drug)
Datesstart 2006-09-01, primary completion 2007-04-01, completion 2007-04-01, first posted 2006-09-19, last updated 2013-09-02
Locations17 sites in United States

Related Papers Related Patents Related Grants Related Experts
All trials for Cancer Cachexia All trials of RC-1291 All trials of placebo

-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.

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+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.

+Arms and interventions

ArmTypeInterventionsDescription
1Placebo comparatorDrug: placebo
2ExperimentalDrug: RC-1291RC-1291 50mg
3ExperimentalDrug: RC-1291RC-1291 100mg
  • RC-1291 (Drug)
  • placebo (Drug)

+Outcome measures

Primary outcomes

  • Body weight; Lean body mass; Functional performance [4 weeks]

+Eligibility

Sex: All, ages: 18 Years to any

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.

+Locations (17)

FacilityCityCountryStatus
Palo Verde Hematology Oncology, Ltd.Glendale, ArizonaUnited States
San Diego Pacific Oncology & Hematology AssociatesEncinitas, CaliforniaUnited States
Sant P. Chawla, MDSanta Monica, CaliforniaUnited States
Melbourne Internal Medicine AssociatesMelbourne, FloridaUnited States
Southwest Oncology AssociatesLafayette, LouisianaUnited States
Center for Cancer and Blood DisordersBethesda, MarylandUnited States
Chesapeake Oncology Hematology Associates, PAGlen Burnie, MarylandUnited States
Beth Israel Cancer CenterNew York, New YorkUnited States
Charleston Cancer CenterCharleston, South CarolinaUnited States
South Carolina Oncology Associates, PAColumbia, South CarolinaUnited States
South Carolina Cancer SpecialistsHilton Head Island, South CarolinaUnited States
University of Texas Medical BranchGalveston, TexasUnited States
Michael E. DeBakey VA Medical CenterHouston, TexasUnited States
Cancer Outreach AssociatesAbingdon, VirginiaUnited States
Virginia Cancer InstituteRichmond, VirginiaUnited States
Multicare Health SystemTacoma, WashingtonUnited States
Northwest Medical SpecialtiesTacoma, WashingtonUnited States

+Investigators