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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
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Population Description
Explanation of how the number of participants for analysis was determined. Includes whether analysis was per protocol, intention to treat, or another method. Also provides relevant details such as imputation technique, as appropriate.
No text entered.

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.

Baseline Measures
    MK-0752 and Docetaxel  
Number of Participants  
[units: participants]
  30  
Age  
[units: years]
 
<=18 years     0  
Between 18 and 65 years     25  
>=65 years     5  
Gender  
[units: participants]
 
Female     30  
Male     0  
Region of Enrollment  
[units: participants]
 
United States     30  
Metastatic sites (multiple sites possible) [1]
[units: Participants]
 
Bone     12  
Lung/Pleura     16  
Liver     13  
Lymph Nodes     11  
Skin     5  
Other     7  
Number of Metastatic Sites  
[units: participants]
 
0     4  
1     6  
2     6  
>=3     14  
Tumor Hormone Receptor Status  
[units: Participants]
 
ER positive/or PgR positive     18  
ER negative and PgR negative     12  
HER-2/neu status  
[units: Participants]
 
Negative     28  
Positive     2  
Prior Therapy For Metastatic Disease [2]
[units: Participants]
 
None     7  
Chemotherapy     7  
Hormonal Therapy     0  
Chemotherapy and Hormonal Therapy     16  
Number of Prior Metastatic Chemotherapy Regimens [3]
[units: Participants]
 
0     7  
1     2  
2+     21  
[1] Metastatic sites at baseline. Patients may have more than one metastatic site at baseline and therefore the total numbers for all categories (all metastatic sites) may be greater than the overall number of baseline participants.
[2] Prior therapy for metastatic disease. Patients may have had more than one prior therapy and therefore the total numbers for all categories (all prior therapies) may be greater than the overall number of baseline participants.
[3] Number of prior metastatic chemotherapy regimens. Patients may have more than one prior metastatic chemotherapy regimen and therefore the total numbers for all categories (all prior metastatic chemotherapy regimens) may be greater than the overall number of baseline participants.



  Outcome Measures
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1.  Primary:   Dose Limiting Toxicity (DLT)   [ Time Frame: first 21 days ]
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Measure Type Primary
Measure Title Dose Limiting Toxicity (DLT)
Measure Description

The number of DLTs experienced by participants within the first 21 days.

DLTs were defined as toxicities possibly, probably, or definitely related to the study drug observed during the first 2 cycles (first 42 days) as follows:

  1. Non-hematologic toxicity Grade ≥3 by the NCI CTCAE version 3.0.
  2. ANC<1000 for more than 7 days despite use of pegfilgrastim.
  3. Platelet count <25,000 for more than 7 days, or associated with bleeding, or less than 10,000 at any time.
Time Frame first 21 days  
Safety Issue Yes  

Population Description
Explanation of how the number of participants for analysis was determined. Includes whether analysis was per protocol, intention to treat, or another method. Also provides relevant details such as imputation technique, as appropriate.
No text entered.

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.

Measured Values
    MK-0752 and Docetaxel  
Number of Participants Analyzed  
[units: participants]
  30  
Dose Limiting Toxicity (DLT)  
[units: Dose┬áLimiting┬áToxicities]
  5  

No statistical analysis provided for Dose Limiting Toxicity (DLT)



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
No text entered.


  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