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Pilot Study of APD209 in Cancer Cachexia

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Acacia Pharma Ltd
ClinicalTrials.gov Identifier:
NCT00895726
First received: May 7, 2009
Last updated: January 12, 2012
Last verified: January 2012
  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: 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

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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: 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
Study First Received: May 7, 2009
Last Updated: January 12, 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

ClinicalTrials.gov processed this record on July 27, 2017