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Pilot Study of APD209 in Cancer Cachexia

This study has been completed.
Information provided by (Responsible Party):
Acacia Pharma Ltd 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: 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

Further study details as provided by Acacia Pharma Ltd:

Primary Outcome Measures:
  • Muscle size and function [ Time Frame: 8 weeks ]

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   (Adult, Senior)
Sexes Eligible for Study:   All
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).
  Contacts and Locations
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Please refer to this study by its 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 Identifier: NCT00895726     History of Changes
Other Study ID Numbers: DC10004
Study First Received: May 7, 2009
Last Updated: January 12, 2012

Keywords provided by Acacia Pharma Ltd:

Additional relevant MeSH terms:
Wasting Syndrome
Weight Loss
Body Weight Changes
Body Weight
Signs and Symptoms
Metabolic Diseases
Nutrition Disorders processed this record on July 27, 2017