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Completed

NCT Number: NCT00378131

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

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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Key information

Conditions

Cancer Cachexia

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 2

Primary location

Palo Verde Hematology Oncology, Ltd., Glendale, Arizona, United States

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About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

RC-1291

Drug

Placebo

Drug

Primary outcomes

  1. Body weight; Lean body mass; Functional performance

    Time frame: 4 weeks

Sponsors and collaborators

Lead sponsor

Helsinn Therapeutics (U.S.), Inc

Industry

Registry information

Official study title

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

Important dates

Study start
2006
Primary completion
2007
Study completion
2007
First posted
Sep 19, 2006
Registry last updated
Sep 2, 2013

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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