Pilot Study of APD209 in Cancer Cachexia

Acacia Pharma

Status and phase: Completed; Phase 2

Conditions: Cancer-related Cachexia

Treatments: Drug: APD209

Study type: Interventional

Funder types: Industry

Identifiers

NCT00895726

DC10004

Details and patient eligibility

About

Primary Objective:

To assess the efficacy of APD209 in adult patients with active cachexia associated with advanced malignancy and not caused by simple starvation.

Secondary Objective:

To assess the safety of APD209 in patients with advanced malignancy and active cachexia.

Enrollment: 13 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion and exclusion criteria

Inclusion Criteria:

• Involuntary loss of weight of >= 2% in 2 months or >= 5% in 6 months, and ongoing in recent weeks, without (or with successfully treated) secondary causes of impaired oral nutritional intake (simple starvation).

Trial design

Primary purpose: Treatment

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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13 participants in 1 patient group

APD209

Experimental group

Treatment:

Drug: APD209