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

Status

Completed

Phases

Phase 2

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT00267358

Enrollment

Unknown

Registered

2005-12-20

Start date

2005-11-30

Completion date

2006-10-31

Last updated

2013-09-02

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Cancer Cachexia

Brief 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.

Interventions

DRUGRC-1291 HCl

DRUGPlacebo

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Masking

DOUBLE

Eligibility

Sex/Gender

ALL

Age

18 Years to No maximum

Healthy volunteers

Inclusion criteria

* Community-dwelling patients ≥ 18 years of age with incurable,histologically diagnosed cancer. * Involuntary loss of body weight of ≥ 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.

Design outcomes

Primary

Measure	Time frame
Body weight	—
Lean body mass	—
Functional performance	—

Countries

United States

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Mar 18, 2026