Tivantinib in Treating Patients With Relapsed, or Relapsed and Refractory Multiple Myeloma

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
National Cancer Institute (NCI)
ClinicalTrials.gov Identifier:
NCT01447914
First received: October 4, 2011
Last updated: March 12, 2015
Last verified: March 2014
Results First Received: January 26, 2015  
Study Type: Interventional
Study Design: Endpoint Classification: Safety/Efficacy Study;   Intervention Model: Single Group Assignment;   Masking: Open Label;   Primary Purpose: Treatment
Condition: Refractory Multiple Myeloma
Interventions: Drug: Tivantinib
Other: Diagnostic laboratory biomarker analysis
Other: Questionnaire administration
Procedure: Quality-of-life assessment

  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
Total Recruitment Period: November 30, 2011 to August 1, 2013. All recruitment done at University of Texas (UT) MD Anderson Cancer Center.

Pre-Assignment Details
Significant events and approaches for the overall study following participant enrollment, but prior to group assignment
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Reporting Groups
  Description
Tivantinib Treatment Oral Tivantinib 360 mg twice daily continuously for each day of every 28 day treatment cycle (taken as three tablets of 120 mg each)

Participant Flow:   Overall Study
    Tivantinib Treatment  
STARTED     16  
COMPLETED     16  
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
Tivantinib Treatment Oral Tivantinib 360 mg twice daily continuously for each day of every 28 day treatment cycle (taken as three tablets of 120 mg each)

Baseline Measures
    Tivantinib Treatment  
Number of Participants  
[units: participants]
  16  
Age  
[units: years]
Mean (Full Range)
  66.3   (49 to 76)  
Gender  
[units: participants]
 
Female     7  
Male     9  
Ethnicity (NIH/OMB)  
[units: participants]
 
Hispanic or Latino     3  
Not Hispanic or Latino     13  
Unknown or Not Reported     0  
Race (NIH/OMB)  
[units: participants]
 
American Indian or Alaska Native     0  
Asian     1  
Native Hawaiian or Other Pacific Islander     0  
Black or African American     2  
White     13  
More than one race     0  
Unknown or Not Reported     0  
Region of Enrollment  
[units: participants]
 
United States     16  
Prior Stem Cell Transplantation (SCT) [1]
[units: participants]
 
Prior SCT     10  
No Prior SCT     6  
[1] Number of participants who had or did not have SCT procedures prior beginning study.



  Outcome Measures
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1.  Primary:   Overall Response Rate (ORR)   [ Time Frame: Up to 30 days ]

2.  Post-Hoc:   Cycles of Tivantinib Treatment Administered   [ Time Frame: From start of participant treatment to completion or disease progression; Data collected for overall study period January 2012 to February 2014. ]

3.  Primary:   Toxicities of Single Agent Tivantinib: Grade 3 Nonhematologic or Grade 4 Hematologic Toxicities According to the Common Terminology Criteria for Adverse Events (CTCAE), Version 4   [ Time Frame: Up to 30 days ]
Results not yet reported.   Anticipated Reporting Date:   No text entered.   Safety Issue:   Yes

4.  Secondary:   Progression-free Survival (PFS)   [ Time Frame: From start of the treatment to disease progression or death (regardless of cause of death), whichever comes first, assessed up to 30 days ]
Results not yet reported.   Anticipated Reporting Date:   No text entered.   Safety Issue:   No

5.  Secondary:   Duration of Response   [ Time Frame: From first observation of partial response to the time of disease progression, assessed up to 30 days ]
Results not yet reported.   Anticipated Reporting Date:   No text entered.   Safety Issue:   No

6.  Secondary:   Time to Next Treatment (TTNT)   [ Time Frame: From registration on trial to next treatment or death due to any cause, whichever comes first, assessed up to 30 days ]
Results not yet reported.   Anticipated Reporting Date:   No text entered.   Safety Issue:   No


  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: Robert Orlowski, MD, PhD / Professor, Department of Lymphoma/Myeloma
Organization: University of Texas (UT) MD Anderson Cancer Center
phone: 713-792-2860
e-mail: CR_Study_Registration@mdanderson.org


No publications provided


Responsible Party: National Cancer Institute (NCI)
ClinicalTrials.gov Identifier: NCT01447914     History of Changes
Other Study ID Numbers: NCI-2011-03470, NCI-2011-03470, CDR0000712984, 2011-0197, 8984, U01CA062461, P30CA016672, N01CM00039
Study First Received: October 4, 2011
Results First Received: January 26, 2015
Last Updated: March 12, 2015
Health Authority: United States: Food and Drug Administration