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

Merck Sharp & Dohme (MSD)

Status and phase

Terminated

Phase 1

Conditions

Advanced Solid Tumors

Treatments

Drug: comparator: docetaxel

Drug: MK6592

Study type

Interventional

Funder types

Industry

Identifiers

6592-001

MK6592-001

2006_508

Details and patient eligibility

About

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

Enrollment

38 estimated patients

Sex

All

Ages

18+ years old

Volunteers

No Healthy Volunteers

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