Open-Label, Pilot Phase I/II Study of the Efficacy and Safety of APD209 in Patients With Cachexia and Advanced Malignancy
Phase 2
18 Years
N/A
18 Years
N/A
Not Enrolling
Both
Cancer-related Cachexia
Both
Cancer-related Cachexia
Trial Information
Open-Label, Pilot Phase I/II Study of the Efficacy and Safety of APD209 in Patients With Cachexia and Advanced Malignancy
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).
Type of Study:
Interventional
Study Design:
Endpoint Classification: Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
Outcome Measure:
Muscle size and function
Outcome Time Frame:
8 weeks
Safety Issue:
No
Principal Investigator
Gabriel Fox, MB BChir
Investigator Role:
Study Director
Investigator Affiliation:
Acacia Pharma Ltd
Authority:
United Kingdom: Medicines and Healthcare Products Regulatory Agency
Study ID:
DC10004
NCT ID:
NCT00895726
Start Date:
March 2009
Completion Date:
January 2012
Related Keywords:
- Cancer-related Cachexia
- cachexia
- neoplasms
- Cachexia
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