Pilot Study of APD209 in Cancer Cachexia

This study has been completed.
Information provided by (Responsible Party):
Acacia Pharma Ltd
ClinicalTrials.gov Identifier:
First received: May 7, 2009
Last updated: January 12, 2012
Last verified: January 2012

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.

Condition Intervention Phase
Cancer-related Cachexia
Drug: APD209
Phase 2

Study Type: Interventional
Study Design: Endpoint Classification: Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: Open-Label, Pilot Phase I/II Study of the Efficacy and Safety of APD209 in Patients With Cachexia and Advanced Malignancy

Resource links provided by NLM:

Further study details as provided by Acacia Pharma Ltd:

Primary Outcome Measures:
  • Muscle size and function [ Time Frame: 8 weeks ] [ Designated as safety issue: No ]

Enrollment: 13
Study Start Date: March 2009
Study Completion Date: January 2012
Primary Completion Date: November 2011 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: APD209 Drug: APD209
Oral tablets twice per day for 56 days


Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No

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).
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Please refer to this study by its ClinicalTrials.gov identifier: NCT00895726

United Kingdom
Royal Infirmary Edinburgh
Edinburgh, United Kingdom
Sponsors and Collaborators
Acacia Pharma Ltd
Study Director: Gabriel Fox, MB BChir Acacia Pharma Ltd
  More Information

Responsible Party: Acacia Pharma Ltd
ClinicalTrials.gov Identifier: NCT00895726     History of Changes
Other Study ID Numbers: DC10004 
Study First Received: May 7, 2009
Last Updated: January 12, 2012
Health Authority: United Kingdom: Medicines and Healthcare Products Regulatory Agency

Keywords provided by Acacia Pharma Ltd:

Additional relevant MeSH terms:
Body Weight
Body Weight Changes
Signs and Symptoms
Weight Loss

ClinicalTrials.gov processed this record on May 23, 2016