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

This study has been terminated.
Sponsor:
Information provided by:
Merck Sharp & Dohme Corp.
ClinicalTrials.gov Identifier:
NCT00359671
First received: August 1, 2006
Last updated: February 12, 2008
Last verified: February 2008
  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 1

Study Type: Interventional
Study Design: Allocation: Non-Randomized
Endpoint Classification: Safety Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: Phase I Study Evaluating MK6592 in Combination With Docetaxel in Adult Patients With Relapsed or Refractory Advanced Solid Tumors

Resource links provided by NLM:


Further study details as provided by Merck Sharp & Dohme Corp.:

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 ]

Estimated Enrollment: 38
Study Start Date: March 2007
Study Completion Date: July 2007
Arms Assigned Interventions
Experimental: 1
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

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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 Sharp & Dohme Corp.
Investigators
Study Director: Medical Monitor Merck Sharp & Dohme Corp.
  More Information

No publications provided

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

Additional relevant MeSH terms:
Neoplasms
Docetaxel
Antineoplastic Agents
Therapeutic Uses
Pharmacologic Actions

ClinicalTrials.gov processed this record on April 17, 2014