Pilot Study of APD209 in Cancer Cachexia

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

Status

Completed

Phases

Phase 2

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT00895726

Enrollment

Registered

2009-05-08

Start date

2009-03-31

Completion date

2012-01-31

Last updated

2012-01-13

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Cancer-related Cachexia

Keywords

cachexia, neoplasms

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.

Interventions

DRUGAPD209

Oral tablets twice per day for 56 days

Study design

Allocation

Intervention model

SINGLE_GROUP

Primary purpose

TREATMENT

Masking

NONE

Eligibility

Sex/Gender

ALL

Age

18 Years to No maximum

Healthy volunteers

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).

Design outcomes

Primary

Measure	Time frame
Muscle size and function	8 weeks

Countries

United Kingdom

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026