Treatment With MK6592 and an Anti-cancer Drug in Patients With Advanced Solid Tumors (6592-001)

• Status: Terminated
• Trial end date: 2007-07-01
• Target enrollment: 0
• Participant gender: All

Summary

A study to evaluate safety and tolerability of MK6592 in combination with an anti-cancer drug in adult patients with advanced solid tumors.

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

Details

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

Criteria

Inclusion Criteria:

• Patients with advanced solid tumors (metastatic or local) unresponsive to standard therapy, progressed on standard therapy, or no standard therapy exists. No limit to the number of prior treatment regimens

• Patients may be fully active without physical restrictions, ambulatory with restrictions on strenuous physical activity, or ambulatory and capable of self-care but not work activities (i.e., Eastern Cooperative Oncology Group performance status of greater than or equal to 2)

• Demonstrates adequate organ function (liver, kidneys, hematologic)

Exclusion Criteria:

• Chemotherapy or radiation therapy within 2 weeks of dosing; or unresolved side effects(s) from prior treatment regimen

• Participation in an investigational study within 14 days of dosing

• Primary central nervous system tumor

• Active brain or spinal cord metastases. Patients who completed a course of therapy for CNS metastases may be eligible if considered clinically stable for 3 months prior to study entry

• Symptoms from fluid in the abdomen or around the lungs

• Requires certain drugs or other products known to be metabolized by the liver enzyme CYP3A4