Pilot Study of APD209 in Cancer Cachexia

Phase 2

Completed

• Conditions: Cancer-related Cachexia
• Interventions: Drug: APD209

• Registration Number: NCT00895726
• Lead Sponsor: Acacia Pharma Ltd

Brief Summary

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2009-03
• Study First Submitted: 2009-05-07
• Study First Submitted QC: 2009-05-07
• Study First Posted: 2009-05-08
• Primary Completion: 2011-11
• Status Verified: 2012-01
• Study Completion: 2012-01
• Last Update Submitted: 2012-01-12
• Last Update Posted: 2012-01-13

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 13

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).

Exclusion Criteria

Not provided

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
APD209	APD209	-

Primary Outcome Measures

Name	Time	Method
Muscle size and function	8 weeks

Trial Locations

Locations (1)

Royal Infirmary Edinburgh; 🇬🇧 Edinburgh, United Kingdom