Title
Pilot Study of APD209 in Cancer Cachexia
Open-Label, Pilot Phase I/II Study of the Efficacy and Safety of APD209 in Patients With Cachexia and Advanced Malignancy
Phase
Phase 2Lead Sponsor
Acacia Pharma LtdStudy Type
InterventionalStatus
Completed No Results PostedIndication/Condition
Cancer-related CachexiaIntervention/Treatment
megestrol formoterol ...Study Participants
13Primary 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.
Oral tablets twice per day for 56 days
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).