Pilot Study of APD209 in Cancer Cachexia

Cancer-related Cachexia Clinical Trial

Official title:

Open-Label, Pilot Phase I/II Study of the Efficacy and Safety of APD209 in Patients With Cachexia and Advanced Malignancy

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00895726
• Other study ID #: DC10004
• Status: Completed
• Phase: Phase 2
• First received: May 7, 2009
• Last updated: January 12, 2012
• Start date: March 2009
• Est. completion date: January 2012

Study information

• Verified date: January 2012
• Source: Acacia Pharma Ltd
• Contact: n/a
• Is FDA regulated: No
• Health authority: United Kingdom: Medicines and Healthcare Products Regulatory Agency
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 13
• Est. completion date: January 2012
• Est. primary completion date: November 2011
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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).

Study Design

Endpoint Classification: Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Cachexia
• Cancer-related Cachexia

Intervention

Drug:
• APD209
Oral tablets twice per day for 56 days

Locations

Country	Name	City	State
United Kingdom	Royal Infirmary Edinburgh	Edinburgh

Sponsors (1)

Lead Sponsor	Collaborator
Acacia Pharma Ltd

Country where clinical trial is conducted

United Kingdom, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Muscle size and function		8 weeks	No