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Pilot Study of APD209 in Cancer Cachexia

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT00895726
First Posted: May 8, 2009
Last Update Posted: January 13, 2012
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.
Information provided by (Responsible Party):
Acacia Pharma Ltd
  Purpose

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: 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

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

  Eligibility

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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
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 ClinicalTrials.gov identifier (NCT number): NCT00895726


Locations
United Kingdom
Royal Infirmary Edinburgh
Edinburgh, United Kingdom
Sponsors and Collaborators
Acacia Pharma Ltd
Investigators
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
First Submitted: May 7, 2009
First Posted: May 8, 2009
Last Update Posted: January 13, 2012
Last Verified: January 2012

Keywords provided by Acacia Pharma Ltd:
cachexia
neoplasms

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