Treatment With MK6592 and an Anti-Cancer Drug in Patients With Advanced Solid Tumors - Full Text View

Sponsored by:	Merck
Information provided by:	Merck
ClinicalTrials.gov Identifier:	NCT00359671

Purpose

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

Condition	Intervention	Phase
Advanced Solid Tumors	Drug: MK6592 Drug: comparator: docetaxel	Phase I

MedlinePlus related topics: Cancer

Drug Information available for: Docetaxel

Study Type:	Interventional
Study Design:	Treatment, Non-Randomized, Open Label, Uncontrolled, Single Group Assignment, Safety Study
Official Title:	Phase I Study Evaluating MK6592 in Combination With Docetaxel in Adult Patients With Relapsed or Refractory Advanced Solid Tumors

Further study details as provided by Merck:

Primary Outcome Measures:

Safety and tolerability of MK6592 alone and in combination with docetaxel [ Time Frame: 6 Months ] [ Designated as safety issue: Yes ]

Secondary Outcome Measures:

Observance of objective tumor responses in patients treated with MK6592 combined with docetaxel [ Time Frame: 6 Months ] [ Designated as safety issue: No ]

Arms	Assigned Interventions
1: Experimental Arm 1: study drug	Drug: MK6592 MK6592 delivered as a 48-hour CIV as monotherapy in Cycle 1; 48-hour CIV of MK6592 in Cycle 2 and subsequent cycles.
2 Arm 2: study drug + comparator	Drug: MK6592 MK6592 delivered as a 48-hour CIV as monotherapy in Cycle 1; 48-hour CIV of MK6592 in Cycle 2 and subsequent cycles. Drug: comparator: docetaxel docetaxel, delivered as a standard IV infusion.

Eligibility

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

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00359671

Sponsors and Collaborators

Merck

Investigators

Study Director:

Medical Monitor

Merck

More Information

Responsible Party:	Merck & Co., Inc. ( Executive Vice President, Clinical and Quantitative Sciences )
Study ID Numbers:	2006_508, MK6592-001
Study First Received:	August 1, 2006
Last Updated:	February 12, 2008
ClinicalTrials.gov Identifier:	NCT00359671
Health Authority:	United States: Food and Drug Administration

Study placed in the following topic categories:

Docetaxel

Additional relevant MeSH terms:

Antineoplastic Agents
Therapeutic Uses
Pharmacologic Actions

ClinicalTrials.gov processed this record on January 16, 2009