Overview

This trial is active, not recruiting.

Condition advanced cancers
Treatment ridaforolimus
Phase phase 2
Sponsor Merck Sharp & Dohme Corp.
Collaborator Ariad Pharmaceuticals
Start date February 2009
End date March 2017
Trial size 7 participants
Trial identifier NCT00836927, 8669-038, AP23573-08-901

Summary

To describe the long-term safety of deforolimus in patients for whom a clinical benefit has been established in a prior parent trial with deforolimus and/or in those who remain in long-term follow-up.

United States No locations recruiting
Other Countries No locations recruiting

Study Design

Endpoint classification safety study
Intervention model single group assignment
Masking open label
Primary purpose treatment
Arm
(Experimental)
Oral or IV deforolimus, as described in the parent protocol. If the parent protocol involves a combination of deforolimus with one or several other drugs, the additional drug(s) may be continued as described in the parent protocol.
ridaforolimus deforolimus
Oral or IV deforolimus, as described in the parent protocol. If the parent protocol involves a combination of deforolimus with one or several other drugs, the additional drug(s) may be continued as described in the parent protocol.

Primary Outcomes

Measure
Safety and tolerability of long-term deforolimus
time frame: Duration of the study

Secondary Outcomes

Measure
Progression free survival
time frame: Duration of the study
Overall Survival
time frame: Duration of the study

Eligibility Criteria

Male or female participants of any age.

Inclusion Criteria: - Patient must have participated on a deforolimus parent trial - Patients must have derived a clinical benefit from the parent trial - Patient is not on any other anti-cancer treatment(s) unless the therapy was allowed on the parent protocol - ECOG performance status less than or equal to 2 if the patient is scheduled to receive treatment with deforolimus; no requirement if the patient is included for follow-up purposes only - Patients of childbearing potential must have a negative pregnancy test within 7 days prior to screening and must use approved contraceptive from screening until 30 days after the last dose of study drug - Signed informed consent Exclusion Criteria: - Has not participated on a parent trial - Women who are to receive study drug who are pregnant or lactating - Any condition in the Investigator's judgment that renders the patient unable to fully understand and provide informed consent and/or comply with the protocol

Additional Information

Official title An Extension Trial of Deforolimus (AP23573; MK-8669), an mTOR Inhibitor, for Patients With Advanced Cancer
Trial information was received from ClinicalTrials.gov and was last updated in November 2016.
Information provided to ClinicalTrials.gov by Merck Sharp & Dohme Corp..