Extension Trial of Deforolimus in Patients With Advanced Cancer (8669-038)

This study is ongoing, but not recruiting participants.

Sponsor:

Collaborator:

Ariad Pharmaceuticals

Information provided by:

Merck

ClinicalTrials.gov Identifier:

NCT00836927

First received: February 3, 2009

Last updated: November 7, 2012

Last verified: November 2012

History of Changes

Tracking Information
First Received Date ^ICMJE	February 3, 2009
Last Updated Date	November 7, 2012
Start Date ^ICMJE	February 2009
Estimated Primary Completion Date	October 2013 (final data collection date for primary outcome measure)
Current Primary Outcome Measures ^ICMJE (submitted: February 3, 2009)	Safety and tolerability of long-term deforolimus [ Time Frame: Duration of the study ] [ Designated as safety issue: Yes ]
Original Primary Outcome Measures ^ICMJE	Same as current
Change History	Complete list of historical versions of study NCT00836927 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures ^ICMJE (submitted: February 3, 2009)	Progression free survival [ Time Frame: Duration of the study ] [ Designated as safety issue: No ] Overall Survival [ Time Frame: Duration of the study ] [ Designated as safety issue: No ]
Original Secondary Outcome Measures ^ICMJE	Same as current
Current Other Outcome Measures ^ICMJE	Not Provided
Original Other Outcome Measures ^ICMJE	Not Provided

Descriptive Information
Brief Title ^ICMJE	Extension Trial of Deforolimus in Patients With Advanced Cancer (8669-038)
Official Title ^ICMJE	An Extension Trial of Deforolimus (AP23573; MK-8669), an mTOR Inhibitor, for Patients With Advanced Cancer
Brief 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.
Detailed Description	Not Provided
Study Type ^ICMJE	Interventional
Study Phase	Not Provided
Study Design ^ICMJE	Endpoint Classification: Safety Study Intervention Model: Single Group Assignment Masking: Open Label Primary Purpose: Treatment
Condition ^ICMJE	Advanced Cancers
Intervention ^ICMJE	Drug: ridaforolimus 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. Other Names: deforolimus AP23573 MK-8669 ridaforolimus was also known as deforolimus until May 2009
Study Arm (s)	Experimental: 1 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. Intervention: Drug: ridaforolimus
Publications *	Not Provided
* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.

Recruitment Information
Recruitment Status ^ICMJE	Active, not recruiting
Enrollment ^ICMJE	7
Estimated Completion Date	October 2013
Estimated Primary Completion Date	October 2013 (final data collection date for primary outcome measure)
Eligibility Criteria ^ICMJE	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
Gender	Both
Ages	Not Provided
Accepts Healthy Volunteers	No
Contacts ^ICMJE	Contact information is only displayed when the study is recruiting subjects
Location Countries ^ICMJE	Not Provided

Administrative Information
NCT Number ^ICMJE	NCT00836927
Other Study ID Numbers ^ICMJE	AP23573-08-901
Has Data Monitoring Committee	No
Responsible Party	Vice President, Late Stage Development Group Leader, Merck Sharp & Dohme Corp
Study Sponsor ^ICMJE	Merck
Collaborators ^ICMJE	Ariad Pharmaceuticals
Investigators ^ICMJE	Not Provided
Information Provided By	Merck
Verification Date	November 2012
^ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP

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