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

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. Identifier: NCT00645333
Recruitment Status : Completed
First Posted : March 27, 2008
Results First Posted : April 4, 2014
Last Update Posted : April 4, 2014
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

Study Type: Interventional
Study Design: Intervention Model: Single Group Assignment;   Masking: None (Open Label);   Primary Purpose: Treatment
Condition: Metastatic Breast Cancer
Intervention: Drug: MK-0752, Docetaxel, Pegfilgrastim

  Participant Flow

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
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

  Baseline Characteristics

  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

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

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

Publications of Results:

Responsible Party: Ann Schott, MD, University of Michigan Cancer Center Identifier: NCT00645333     History of Changes
Other Study ID Numbers: UMCC 2006.119
First Submitted: March 24, 2008
First Posted: March 27, 2008
Results First Submitted: August 9, 2013
Results First Posted: April 4, 2014
Last Update Posted: April 4, 2014