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Pilot Study of APD209 in Cancer Cachexia

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT00895726
Recruitment Status : Completed
First Posted : May 8, 2009
Last Update Posted : January 13, 2012
Information provided by (Responsible Party):
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.

Condition or disease Intervention/treatment Phase
Cancer-related Cachexia Drug: APD209 Phase 2

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 13 participants
Intervention Model: Single Group Assignment
Masking: None (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
Study Start Date : March 2009
Actual Primary Completion Date : November 2011
Actual Study Completion Date : January 2012

Arm Intervention/treatment
Experimental: APD209 Drug: APD209
Oral tablets twice per day for 56 days

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

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
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).

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT00895726

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

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Responsible Party: Acacia Pharma Ltd Identifier: NCT00895726     History of Changes
Other Study ID Numbers: DC10004
First Posted: May 8, 2009    Key Record Dates
Last Update Posted: January 13, 2012
Last Verified: January 2012

Keywords provided by Acacia Pharma Ltd:

Additional relevant MeSH terms:
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Wasting Syndrome
Weight Loss
Body Weight Changes
Body Weight
Signs and Symptoms
Metabolic Diseases
Nutrition Disorders