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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 (Responsible Party):
Merck Sharp & Dohme Corp.
ClinicalTrials.gov Identifier:
NCT00836927
First received: February 3, 2009
Last updated: July 15, 2014
Last verified: July 2014

February 3, 2009
July 15, 2014
February 2009
October 2014   (final data collection date for primary outcome measure)
Safety and tolerability of long-term deforolimus [ Time Frame: Duration of the study ] [ Designated as safety issue: Yes ]
Same as current
Complete list of historical versions of study NCT00836927 on ClinicalTrials.gov Archive Site
  • 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 ]
Same as current
Not Provided
Not Provided
 
Extension Trial of Deforolimus in Patients With Advanced Cancer (8669-038)
An Extension Trial of Deforolimus (AP23573; MK-8669), an mTOR Inhibitor, for Patients With Advanced Cancer

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.

Not Provided
Interventional
Not Provided
Endpoint Classification: Safety Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Advanced Cancers
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
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
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Active, not recruiting
7
October 2014
October 2014   (final data collection date for primary outcome measure)

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
Both
Not Provided
No
Contact information is only displayed when the study is recruiting subjects
Not Provided
 
NCT00836927
8669-038, AP23573-08-901
No
Merck Sharp & Dohme Corp.
Merck Sharp & Dohme Corp.
Ariad Pharmaceuticals
Not Provided
Merck Sharp & Dohme Corp.
July 2014

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP