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

NCT00359671 | Terminated Phase 1

• 3 other identifiers: 6592-001MK6592-0012006_508
• Study Type: interventional
• Target: 38
• Locations: 0 countries
• Sites: N/A

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.

Conditions

Advanced Solid Tumors

Outcome Measures

Primary Outcomes (1)

• Safety and tolerability of MK6592 alone and in combination with docetaxel

  6 Months

Secondary Outcomes (1)

• Observance of objective tumor responses in patients treated with MK6592 combined with docetaxel

  6 Months

Study Arms (2)

1

EXPERIMENTAL

Arm 1: study drug

Drug: MK6592

2

OTHER

Arm 2: study drug + comparator

Drug: MK6592; Drug: comparator: docetaxel

Interventions

MK6592 DRUG

MK6592 delivered as a 48-hour CIV as monotherapy in Cycle 1; 48-hour CIV of MK6592 in Cycle 2 and subsequent cycles.

1; 2

comparator: docetaxel DRUG

docetaxel, delivered as a standard IV infusion.

2

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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)

You may not qualify if:

• 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

Sponsors & Collaborators

• Merck Sharp & Dohme LLC: lead

Study Officials

• Medical Monitor

  Merck Sharp & Dohme LLC

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: August 1, 2006
• First Posted: August 2, 2006
• Study Start: December 1, 2006
• Primary Completion: July 1, 2007
• Study Completion: July 1, 2007
• Last Updated: November 29, 2016

Record last verified: 2016-11