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

Helsinn Healthcare

Status and phase: Completed; Phase 2

Conditions: Cancer Cachexia

Treatments: Drug: placebo; Drug: RC-1291

Study type: Interventional

Funder types: Industry

Identifiers

NCT00378131

RC-1291-206

Details and patient eligibility

About

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.

Full 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.

Enrollment: 51 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Triple Blind

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51 participants in 3 patient groups, including a placebo group

1

Placebo Comparator group

Treatment:

Drug: placebo

2

Experimental group

Description:

RC-1291 50mg

Treatment:

Drug: RC-1291

3

Experimental group

Description:

RC-1291 100mg

Treatment:

Drug: RC-1291