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Cabozantinib (XL184) in Patients With Relapsed or Refractory Myeloma

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT01866293
First Posted: May 31, 2013
Last Update Posted: August 30, 2017
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.
Collaborator:
Exelixis
Information provided by (Responsible Party):
Memorial Sloan Kettering Cancer Center
Results First Submitted: August 1, 2017  
Study Type: Interventional
Study Design: Intervention Model: Single Group Assignment;   Masking: None (Open Label);   Primary Purpose: Treatment
Condition: Relapsed or Refractory Multiple Myeloma
Intervention: Drug: Cabozantinib (XL184)

  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
Protocol Open to Accrual 05/28/2013 Protocol Closed to Accrual 09/16/2015 Primary Completion Date 08/18/2016 Recruitment Location is the medical clinic

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
Cabozantinib (XL184)

Eligible patients will receive cabozantinib as a tablet, orally daily. One cycle is defined as 28 days. Myeloma response will be assessed by IMWG criteria after each cycle. The DLT evaluation period will be six weeks. This trial will be a standard 3 by 3 dose escalation design, where three daily dose levels (20mg, 40mg, and 60mg) will be investigated.

Cabozantinib (XL184)


Participant Flow:   Overall Study
    Cabozantinib (XL184)
STARTED   11 
COMPLETED   9 
NOT COMPLETED   2 
Adverse Event                2 



  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
Cabozantinib (XL184)

Eligible patients will receive cabozantinib as a tablet, orally daily. One cycle is defined as 28 days. Myeloma response will be assessed by IMWG criteria after each cycle. The DLT evaluation period will be six weeks. This trial will be a standard 3 by 3 dose escalation design, where three daily dose levels (20mg, 40mg, and 60mg) will be investigated.

Cabozantinib (XL184)


Baseline Measures
   Cabozantinib (XL184) 
Overall Participants Analyzed 
[Units: Participants]
 11 
Age 
[Units: Years]
Median (Full Range)
 63 
 (53 to 75) 
Sex: Female, Male 
[Units: Participants]
Count of Participants
 
Female      5  45.5% 
Male      6  54.5% 
Ethnicity (NIH/OMB) 
[Units: Participants]
Count of Participants
 
Hispanic or Latino      2  18.2% 
Not Hispanic or Latino      9  81.8% 
Unknown or Not Reported      0   0.0% 
Race (NIH/OMB) 
[Units: Participants]
Count of Participants
 
American Indian or Alaska Native      0   0.0% 
Asian      0   0.0% 
Native Hawaiian or Other Pacific Islander      0   0.0% 
Black or African American      3  27.3% 
White      7  63.6% 
More than one race      0   0.0% 
Unknown or Not Reported      1   9.1% 
Region of Enrollment 
[Units: Participants]
 
United States   11 


  Outcome Measures
  Show All Outcome Measures

1.  Primary:   Maximally Tolerated Dose   [ Time Frame: 1 year ]

2.  Secondary:   Overall Response Rate   [ Time Frame: 1 year ]

3.  Secondary:   Safety and Toxicity in This Patient Population   [ Time Frame: 1 year ]

4.  Secondary:   Time to Progression (TTP)   [ Time Frame: 1 year ]

5.  Secondary:   Duration of Response (DOR)   [ Time Frame: 1 year ]


  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:  
All Principal Investigators ARE employed by the organization sponsoring the study.


Results Point of Contact:  
Name/Title: Sergio Giralt, MD
Organization: Memorial Sloan Kettering Cancer Center
phone: 212-639-6009
e-mail: GiraltS@mskcc.org



Responsible Party: Memorial Sloan Kettering Cancer Center
ClinicalTrials.gov Identifier: NCT01866293     History of Changes
Other Study ID Numbers: 12-240
First Submitted: May 28, 2013
First Posted: May 31, 2013
Results First Submitted: August 1, 2017
Results First Posted: August 30, 2017
Last Update Posted: August 30, 2017