This is a two part study of the drug MK-8669 (ridaforolimus) given with MK-2206 or MK-0752. In Part A of the study, the preliminary maximum tolerated dose (MTD) of the drug combinations will be found by giving sequentially higher doses of the study drugs. An expansion cohort of participants may be enrolled to confirm the MTD. New cohorts at other dose levels may be enrolled, depending on the rate of dose limiting toxicities (DLTs) in the planned cohorts. In Part B, an assessment of the efficacy of the drug combinations against selected advanced cancers will be made so that a recommended dose to be used in Phase 2 studies (RPTD) can be found. As of 19 July 2012 the MK-0752 arms of the study were fully enrolled and closed to further recruitment. As of 30 November 2012, no additional participants with prostate cancer will be enrolled.
Study Type
INTERVENTIONAL
Allocation
NON_RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
65
10 mg enteric-coated tablets, orally, starting dose 2 tablets and escalating to 4 tablets each day for 5 days per week.
300 mg capsule, orally, 6 capsules per dose, once each week.
Tablets (5 mg, 25 mg, and 200 mg) to equal starting dose of 90 mg and escalating to 200 mg per dose, orally, once each week.
Number of participants receiving ridaforolimus + MK-2206 who experience dose-limiting toxicities (DLTs).
Time frame: Cycle 1 (28 days)
Number of participants receiving ridaforolimus + MK-0752 who experience DLTs.
Time frame: Cycle 1 (28 days)
Number of participants whose best response is partial response (PR) or complete response (CR).
Time frame: Day 22-29, every other month.
Area under the plasma concentration curve (AUC) for ridaforolimus.
Time frame: Part A, Cycle 0, Day 1 (pre-dose)
Area under the plasma concentration curve (AUC) for ridaforolimus.
Time frame: Part A, Cycle 0, Day 5 (pre- and post-dose)
AUC for the ridaforolimus + MK-0752 doublet
Time frame: Part A, Cycle 1, Day 1 (pre-dose)
AUC for the ridaforolimus + MK-0752 doublet
Time frame: Part A, Cycle 1, Day 12 (pre- and post-dose)
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