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An Extension Trial of Deforolimus (AP23573; MK-8669), an mTOR Inhibitor, for Patients With Advanced Cancer


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Open (Enrolling)
Both
Advanced Cancers

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Trial Information

An Extension Trial of Deforolimus (AP23573; MK-8669), an mTOR Inhibitor, for Patients With Advanced Cancer


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

Type of Study:

Interventional

Study Design:

Endpoint Classification: Safety Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Outcome Measure:

Safety and tolerability of long-term deforolimus

Outcome Time Frame:

Duration of the study

Safety Issue:

Yes

Authority:

United States: Food and Drug Administration

Study ID:

AP23573-08-901

NCT ID:

NCT00836927

Start Date:

February 2009

Completion Date:

October 2013

Related Keywords:

  • Advanced Cancers
  • Neoplasms

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