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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT00359671
Recruitment Status : Terminated
First Posted : August 2, 2006
Last Update Posted : November 29, 2016
Sponsor:
Information provided by (Responsible Party):
Merck Sharp & Dohme Corp.

Tracking Information
First Submitted Date  ICMJE August 1, 2006
First Posted Date  ICMJE August 2, 2006
Last Update Posted Date November 29, 2016
Study Start Date  ICMJE December 2006
Actual Primary Completion Date July 2007   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: December 23, 2007)
Safety and tolerability of MK6592 alone and in combination with docetaxel [ Time Frame: 6 Months ]
Original Primary Outcome Measures  ICMJE
 (submitted: August 1, 2006)
Proprietary Information - Exploratory (Non-Confirmatory) Trial
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: December 23, 2007)
Observance of objective tumor responses in patients treated with MK6592 combined with docetaxel [ Time Frame: 6 Months ]
Original Secondary Outcome Measures  ICMJE
 (submitted: August 1, 2006)
Proprietary Information - Exploratory (Non-Confirmatory) Trial
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Treatment With MK6592 and an Anti-cancer Drug in Patients With Advanced Solid Tumors (6592-001)
Official Title  ICMJE Phase I Study Evaluating MK6592 in Combination With Docetaxel in Adult Patients With Relapsed or Refractory Advanced Solid Tumors
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 Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 1
Study Design  ICMJE Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Condition  ICMJE Advanced Solid Tumors
Intervention  ICMJE
  • 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.
Study Arms  ICMJE
  • Experimental: 1
    Arm 1: study drug
    Intervention: Drug: MK6592
  • 2
    Arm 2: study drug + comparator
    Interventions:
    • Drug: MK6592
    • Drug: comparator: docetaxel
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Terminated
Estimated Enrollment  ICMJE
 (submitted: August 1, 2006)
38
Original Enrollment  ICMJE Same as current
Actual Study Completion Date  ICMJE July 2007
Actual Primary Completion Date July 2007   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE Not Provided
Removed Location Countries United States
 
Administrative Information
NCT Number  ICMJE NCT00359671
Other Study ID Numbers  ICMJE 6592-001
MK6592-001
2006_508
Has Data Monitoring Committee Not Provided
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Merck Sharp & Dohme Corp.
Study Sponsor  ICMJE Merck Sharp & Dohme Corp.
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Study Director: Medical Monitor Merck Sharp & Dohme Corp.
PRS Account Merck Sharp & Dohme Corp.
Verification Date November 2016

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP