Safety and Tolerability of Different Dose Combinations of Ridaforolimus With MK-2206 or MK-0752 for Participants With Advanced Cancer (MK-8669-049)

Summary

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.

Timeline

Start

2011-02

Primary completion

2013-12

Completion

2015-08

Publications

• Background Piha-Paul SA, Munster PN, Hollebecque A, Argiles G, Dajani O, Cheng JD, Wang R, Swift A, Tosolini A, Gupta S. Results of a phase 1 trial combining ridaforolimus and MK-0752 in patients with advanced solid tumours. Eur J Cancer. 2015 Sep;51(14):1865-73. doi: 10.1016/j.ejca.2015.06.115. Epub 2015 Jul 18.
• Background Gupta S, Argiles G, Munster PN, Hollebecque A, Dajani O, Cheng JD, Wang R, Swift A, Tosolini A, Piha-Paul SA. A Phase I Trial of Combined Ridaforolimus and MK-2206 in Patients with Advanced Malignancies. Clin Cancer Res. 2015 Dec 1;21(23):5235-44. doi: 10.1158/1078-0432.CCR-15-0180. Epub 2015 Jul 17.

Drugs

Indications