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

Phase 1

Terminated

• Conditions: Advanced Solid Tumors
• Interventions: Drug: MK6592

• Registration Number: NCT00359671
• Lead Sponsor: Merck Sharp & Dohme LLC

Brief Summary

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

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2006-08-01
• Study First Submitted QC: 2006-08-01
• Study First Posted: 2006-08-02
• Study Start: 2006-12
• Primary Completion: 2007-07
• Study Completion: 2007-07
• Status Verified: 2016-11
• Last Update Submitted: 2016-11-28
• Last Update Posted: 2016-11-29

Recruitment & Eligibility

• Status: TERMINATED
• Sex: All
• Target Recruitment: 38

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
1	MK6592	Arm 1: study drug
2	MK6592	Arm 2: study drug + comparator

Primary Outcome Measures

Name	Time	Method
Safety and tolerability of MK6592 alone and in combination with docetaxel	6 Months

Secondary Outcome Measures

Name	Time	Method
Observance of objective tumor responses in patients treated with MK6592 combined with docetaxel	6 Months