Phase I/II Study of MK-0752 Followed by Docetaxel in Advanced or Metastatic Breast Cancer

This study has been completed.
Sponsor:
Collaborators:
Baylor College of Medicine
Ohio State University
Dana-Farber Cancer Institute
Weill Medical College of Cornell University
Merck Sharp & Dohme Corp.
Information provided by (Responsible Party):
Ann Schott, MD, University of Michigan Cancer Center
ClinicalTrials.gov Identifier:
NCT00645333
First received: March 24, 2008
Last updated: February 24, 2014
Last verified: February 2014
Results First Received: August 9, 2013  
Study Type: Interventional
Study Design: Endpoint Classification: Safety Study;   Intervention Model: Single Group Assignment;   Masking: Open Label;   Primary Purpose: Treatment
Condition: Metastatic Breast Cancer
Intervention: Drug: MK-0752, Docetaxel, Pegfilgrastim

  Participant Flow
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Recruitment Details
Key information relevant to the recruitment process for the overall study, such as dates of the recruitment period and locations
Eligible subjects included men or women with metastatic (Stage IV)breast cancer, or with locally advanced breast cancer (Stages IIIA> 10cm, or stages IIIB and IIIC) that did not respond to first-line anthracycline-based chemotherapy.

Pre-Assignment Details
Significant events and approaches for the overall study following participant enrollment, but prior to group assignment
There must b at least a 6 month interval since prior taxane therapy.

Reporting Groups
  Description
MK-0752 and Docetaxel MK-0752 in escalating doses, orally days 1-3, followed by docetaxel 80 mg/m2 IV on day 8, and pegfilgrastim 6mg SQ day 9. Cycle repeated every 21 days.

Participant Flow:   Overall Study
    MK-0752 and Docetaxel  
STARTED     30  
COMPLETED     30  
NOT COMPLETED     0  



  Baseline Characteristics


  Outcome Measures
  Show All Outcome Measures

1.  Primary:   Dose Limiting Toxicity (DLT)   [ Time Frame: first 21 days ]

2.  Primary:   Maximum Tolerated Dose (MTD)   [ Time Frame: Up to 3 years ]


  Serious Adverse Events


  Other Adverse Events


  Limitations and Caveats
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Limitations of the study, such as early termination leading to small numbers of participants analyzed and technical problems with measurement leading to unreliable or uninterpretable data
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  More Information
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Certain Agreements:  
Principal Investigators are NOT employed by the organization sponsoring the study.
There is NOT an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.


Results Point of Contact:  
Name/Title: Anne F. Schott, MD
Organization: University of Michigan
phone: 1-800-865-1125
e-mail: canceranswerline@umich.edu


Publications of Results:

Responsible Party: Ann Schott, MD, University of Michigan Cancer Center
ClinicalTrials.gov Identifier: NCT00645333     History of Changes
Other Study ID Numbers: UMCC 2006.119
Study First Received: March 24, 2008
Results First Received: August 9, 2013
Last Updated: February 24, 2014
Health Authority: United States: Institutional Review Board
United States: Food and Drug Administration