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

This study has been terminated.
Sponsor:
Information provided by (Responsible Party):
Merck Sharp & Dohme Corp.
ClinicalTrials.gov Identifier:
NCT00359671
First received: August 1, 2006
Last updated: May 21, 2014
Last verified: May 2014
  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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

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: Merck Sharp & Dohme Corp.
ClinicalTrials.gov Identifier: NCT00359671     History of Changes
Other Study ID Numbers: 6592-001, MK6592-001, 2006_508
Study First Received: August 1, 2006
Last Updated: May 21, 2014
Health Authority: United States: Food and Drug Administration

Additional relevant MeSH terms:
Neoplasms
Docetaxel
Antimitotic Agents
Antineoplastic Agents
Mitosis Modulators
Molecular Mechanisms of Pharmacological Action
Pharmacologic Actions
Therapeutic Uses
Tubulin Modulators

ClinicalTrials.gov processed this record on October 29, 2014