NCT00895726

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
13

participants targeted

Target at below P25 for phase_2

Timeline
Completed

Started Mar 2009

Typical duration for phase_2

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

March 1, 2009

Completed
2 months until next milestone

First Submitted

Initial submission to the registry

May 7, 2009

Completed
1 day until next milestone

First Posted

Study publicly available on registry

May 8, 2009

Completed
2.5 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

November 1, 2011

Completed
2 months until next milestone

Study Completion

Last participant's last visit for all outcomes

January 1, 2012

Completed
Last Updated

January 13, 2012

Status Verified

January 1, 2012

Enrollment Period

2.7 years

First QC Date

May 7, 2009

Last Update Submit

January 12, 2012

Conditions

Cancer-related Cachexia

Keywords

cachexianeoplasms

Outcome Measures

Primary Outcomes (1)

  • Muscle size and function

    8 weeks

Study Arms (1)

APD209

EXPERIMENTAL
Drug: APD209

Interventions

APD209DRUG

Oral tablets twice per day for 56 days

APD209

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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).

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Royal Infirmary Edinburgh

Edinburgh, United Kingdom

Location

MeSH Terms

Conditions

CachexiaNeoplasms

Condition Hierarchy (Ancestors)

Weight LossBody Weight ChangesBody WeightSigns and SymptomsPathological Conditions, Signs and SymptomsThinness

Study Officials

  • Gabriel Fox, MB BChir

    Acacia Pharma Ltd

    STUDY DIRECTOR

Study Design

Study Type
interventional
Phase
phase 2
Allocation
NA
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

May 7, 2009

First Posted

May 8, 2009

Study Start

March 1, 2009

Primary Completion

November 1, 2011

Study Completion

January 1, 2012

Last Updated

January 13, 2012

Record last verified: 2012-01

Locations

GB(1)