Treatment of Participants With Advanced and/or Refractory Solid Tumors (MK-5108-001)

A Phase I Investigation of MK-5108 and MK-5108 With Docetaxel in Patients With Advanced Solid Tumors

This study will investigate the safety, side effects and how well the body tolerates MK-5108 as well as determine different doses of MK-5108 in participants with advanced and/or refractory solid tumors. The corresponding primary hypotheses of this study are that 1) administration of oral MK-5108 (twice daily for 2 out of 14-21 days) to participants with advanced and/or refractory solid tumors will be safe and tolerable, and that 2) the spectrum of side effects observed in these participants after administration of oral MK-5108 alone and in combination with docetaxel will be dose-dependent and allow for definition of a maximum tolerated dose (MTD).

Inclusion Criteria:

- Participant has a histologically-confirmed metastatic or locally advanced solid tumor that has failed to respond to standard therapy or progressed with standard therapy

Exclusion Criteria:

• Participant has had chemotherapy, radiotherapy or biological therapy within 4 weeks prior to study start or has not recovered from adverse events caused by therapy more than 4 weeks earlier
• Participant is currently participating or has participated in a study with an investigational compound or device within 4 weeks prior to signing informed consent
• Participant has received more than 2 courses of chemotherapy for metastatic disease
• Participant has had prolonged neutropenia or neutropenia with fever from previous chemotherapy treatment
• Participant has a primary central nervous system tumor
• Participant is a regular or recreational user of any illicit drugs or has a recent history within the last year of drug or alcohol abuse
• Participant is pregnant, breastfeeding or planning to have children during the study
• Participant is Human Immunodeficiency Virus (HIV) positive
• Participant has a history of Hepatitis B or C