Tivantinib in Treating Patients With Recurrent or Metastatic Breast Cancer

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
National Cancer Institute (NCI)
ClinicalTrials.gov Identifier:
NCT01575522
First received: April 10, 2012
Last updated: February 23, 2016
Last verified: October 2015
Results First Received: November 12, 2015  
Study Type: Interventional
Study Design: Endpoint Classification: Efficacy Study;   Intervention Model: Single Group Assignment;   Masking: Open Label;   Primary Purpose: Treatment
Conditions: Estrogen Receptor Negative
HER2/Neu Negative
Progesterone Receptor Negative
Recurrent Breast Carcinoma
Stage IV Breast Cancer
Triple-Negative Breast Carcinoma
Interventions: Other: Laboratory Biomarker Analysis
Drug: Tivantinib

  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
No text entered.

Pre-Assignment Details
Significant events and approaches for the overall study following participant enrollment, but prior to group assignment
No text entered.

Reporting Groups
  Description
Treatment (Tivantinib)

Patients receive tivantinib 360 mg PO BID on days 1-21. Courses repeat every 21 days in the absence of disease progression or unacceptable toxicity. Patients undergo blood sample collection at baseline and periodically during study for c-Met expression, relevant markers (HGF and VEGF), PTEN loss, and PI3K mutation analysis by FISH and IHC. Archived tumor tissue samples are also analyzed.

Laboratory Biomarker Analysis: Correlative studies

Tivantinib: Given PO


Participant Flow:   Overall Study
    Treatment (Tivantinib)  
STARTED     22  
COMPLETED     22  
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
Treatment (Tivantinib)

Patients receive tivantinib PO BID on days 1-21. Courses repeat every 21 days in the absence of disease progression or unacceptable toxicity. Patients undergo blood sample collection at baseline and periodically during study for c-Met expression, relevant markers (HGF and VEGF), PTEN loss, and PI3K mutation analysis by FISH and IHC. Archived tumor tissue samples are also analyzed.

Laboratory Biomarker Analysis: Correlative studies

Tivantinib: Given PO


Baseline Measures
    Treatment (Tivantinib)  
Number of Participants  
[units: participants]
  22  
Age  
[units: years]
Mean (Standard Deviation)
  55  (10)  
Gender  
[units: participants]
 
Female     22  
Male     0  
Race/Ethnicity, Customized  
[units: participants]
 
White     20  
Black or African American     2  



  Outcome Measures
  Show All Outcome Measures

1.  Primary:   PFS Status   [ Time Frame: Time from start of treatment to time of progression or death, assessed up to 6 months ]

2.  Secondary:   Overall Response Using RECIST v1.1   [ Time Frame: Up to 1 year ]

3.  Secondary:   To Evaluate c-Met Expression in Archival Tumor Tissue.   [ Time Frame: Baseline ]

4.  Secondary:   To Evaluate Phospho c-Met Expression in Archival Tumor Tissue.   [ Time Frame: Baseline ]

5.  Secondary:   To Evaluate the Incidence of c-Met Positive Circulating Tumor Cells.   [ Time Frame: Baseline ]


  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 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.
The agreement is:
unchecked The only disclosure restriction on the PI is that the sponsor can review results communications prior to public release and can embargo communications regarding trial results for a period that is more than 60 days but less than or equal to 180 days. The sponsor cannot require changes to the communication and cannot extend the embargo.
unchecked Other disclosure agreement that restricts the right of the PI to discuss or publish trial results after the trial is completed.


Results Point of Contact:  
Name/Title: Sara M. Tolaney, MD, MPH
Organization: Dana-Farber Cancer Institute
phone: 617.632.5743
e-mail: Sara_Tolaney@dfci.harvard.edu


Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

Responsible Party: National Cancer Institute (NCI)
ClinicalTrials.gov Identifier: NCT01575522     History of Changes
Obsolete Identifiers: NCT01542996
Other Study ID Numbers: NCI-2012-00722
NCI-2012-00722 ( Registry Identifier: CTRP (Clinical Trial Reporting Program) )
DFCI-12-017
CDR0000730102
12-017 ( Other Identifier: Dana-Farber Cancer Institute )
8985 ( Other Identifier: CTEP )
P30CA006516 ( US NIH Grant/Contract Award Number )
U01CA062490 ( US NIH Grant/Contract Award Number )
Study First Received: April 10, 2012
Results First Received: November 12, 2015
Last Updated: February 23, 2016
Health Authority: United States: Food and Drug Administration
United States: Federal Government