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

• Status: Completed
• Trial end date: 2011-04-04
• Target enrollment: 0
• Participant gender: All

Summary

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).

• Phase: Phase 1
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Merck Sharp & Dohme Corp.
• Treatments: Docetaxel

Criteria

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