Back to resultsPilot Study of APD209 in Cancer Cachexia
Primary Purpose
Cancer-related Cachexia
Status
Completed
Phase
Phase 2
Locations
United Kingdom
Study Type
Interventional
Intervention
APD209
Sponsored by
About this trial
This is an interventional treatment trial for Cancer-related Cachexia focused on measuring cachexia, neoplasms
Eligibility 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).
Sites / Locations
- Royal Infirmary Edinburgh
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
APD209
Arm Description
Outcomes
Primary Outcome Measures
Muscle size and function
Secondary Outcome Measures
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT00895726
Brief Title
Pilot Study of APD209 in Cancer Cachexia
Official Title
Open-Label, Pilot Phase I/II Study of the Efficacy and Safety of APD209 in Patients With Cachexia and Advanced Malignancy
Study Type
Interventional
2. Study Status
Record Verification Date
January 2012
Overall Recruitment Status
Completed
Study Start Date
March 2009 (undefined)
Primary Completion Date
November 2011 (Actual)
Study Completion Date
January 2012 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Acacia Pharma Ltd
4. Oversight
Data Monitoring Committee
No
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Cancer-related Cachexia
Keywords
cachexia, neoplasms
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
13 (Actual)
8. Arms, Groups, and Interventions
Arm Title
APD209
Arm Type
Experimental
Intervention Type
Drug
Intervention Name(s)
APD209
Intervention Description
Oral tablets twice per day for 56 days
Primary Outcome Measure Information:
Title
Muscle size and function
Time Frame
8 weeks
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility 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).
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Gabriel Fox, MB BChir
Organizational Affiliation
Acacia Pharma Ltd
Official's Role
Study Director
Facility Information:
Facility Name
Royal Infirmary Edinburgh
City
Edinburgh
Country
United Kingdom
12. IPD Sharing Statement
Learn more about this trial
Pilot Study of APD209 in Cancer Cachexia
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