MedTrace Logo

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

NCT00267358 · Status: COMPLETED · Phase: PHASE2 · Type: INTERVENTIONAL

Last updated 2013-09-02

No results posted yet for this study

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.

Conditions

  • Cancer Cachexia

Interventions

DRUG

RC-1291 HCl

DRUG

Placebo

Sponsors & Collaborators

  • Helsinn Therapeutics (U.S.), Inc

    lead INDUSTRY

Principal Investigators

  • William Polvino, MD · Helsinn Therapeutics (U.S.), Inc

Study Design

Allocation
RANDOMIZED
Masking
DOUBLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2005-11-30
Primary Completion
2006-10-31
Completion
2006-10-31

Countries

  • United States

Study Locations

More Related Trials

Entities

Drugs

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT00267358 on ClinicalTrials.gov