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Cabozantinib in Advanced Solid Malignancies

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.
ClinicalTrials.gov Identifier: NCT01588821
Recruitment Status : Active, not recruiting
First Posted : May 1, 2012
Results First Posted : January 10, 2018
Last Update Posted : January 10, 2018
Sponsor:
Information provided by (Responsible Party):
Rebecca Suk Heist, MD, Massachusetts General Hospital

Study Type: Interventional
Study Design: Intervention Model: Single Group Assignment;   Masking: None (Open Label);   Primary Purpose: Treatment
Conditions: Lung Cancer
Solid Tumor (Not Breast or Prostate Cancers)
Intervention: Drug: Cabozantinib

  Participant Flow

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
Cabozantinib Cabozantinib: 60 mg daily by mouth

Participant Flow:   Overall Study
    Cabozantinib
STARTED   37 
COMPLETED   37 
NOT COMPLETED   0 



  Baseline Characteristics

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 Cabozantinib: 60 mg daily by mouth

Baseline Measures
   Cabozantinib 
Overall Participants Analyzed 
[Units: Participants]
 37 
Age 
[Units: Years]
Mean (Full Range)
 
Participants Analyzed 
[Units: Participants]
 37 
   54.4 
 (18 to 83) 
Sex: Female, Male 
[Units: Participants]
Count of Participants
 
Participants Analyzed 
[Units: Participants]
 37 
Female      14  37.8% 
Male      23  62.2% 
Race and Ethnicity Not Collected [1] 
[Units: Participants]
Count of Participants
  
[1] Race and Ethnicity were not collected from any participant.
Region of Enrollment 
[Units: Participants]
 
United States   
Participants Analyzed 
[Units: Participants]
 37 
United States   37 
Diagnosis 
[Units: Participants]
Count of Participants
 
Sarcoma   
Participants Analyzed 
[Units: Participants]
 37 
Sarcoma   14 
Renal Cell Carcinoma   
Participants Analyzed 
[Units: Participants]
 37 
Renal Cell Carcinoma   7 
Non-Small cell lung cancer   
Participants Analyzed 
[Units: Participants]
 37 
Non-Small cell lung cancer   5 
Head and neck carcinoma   
Participants Analyzed 
[Units: Participants]
 37 
Head and neck carcinoma   4 
Thyroid Cancer   
Participants Analyzed 
[Units: Participants]
 37 
Thyroid Cancer   2 
Melanoma   
Participants Analyzed 
[Units: Participants]
 37 
Melanoma   2 
Adenoid Cystic Carcinoma   
Participants Analyzed 
[Units: Participants]
 37 
Adenoid Cystic Carcinoma   1 
Metastatic chondroblastoma   
Participants Analyzed 
[Units: Participants]
 37 
Metastatic chondroblastoma   1 
Chordoma   
Participants Analyzed 
[Units: Participants]
 37 
Chordoma   1 


  Outcome Measures

1.  Primary:   Number of Participants With Bone Bio-marker Response   [ Time Frame: 8 Weeks ]

2.  Secondary:   Overall Tumor Response Rate   [ Time Frame: 2 years ]

3.  Secondary:   Rate of Skeletal-related Event (SRE)   [ Time Frame: 2 years ]
Results not yet reported.   Anticipated Reporting Date:   01/2019  

4.  Secondary:   Quality of Life   [ Time Frame: 2 years ]
Results not yet reported.   Anticipated Reporting Date:   01/2019  

5.  Secondary:   MET Amplification in Tumor Sample   [ Time Frame: 2 years ]
Results not yet reported.   Anticipated Reporting Date:   01/2019  

6.  Secondary:   Response to Cabozantinib in Bone Metastatic Disease   [ Time Frame: 2 years ]
Results not yet reported.   Anticipated Reporting Date:   01/2019  

7.  Secondary:   Time to SRE   [ Time Frame: 2 years ]
Results not yet reported.   Anticipated Reporting Date:   01/2019  


  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
No text entered.


  More Information

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


Results Point of Contact:  
Name/Title: Rebecca Suk Heist, MD
Organization: Massachusetts General Hospital
phone: 617-724-4000
e-mail: rheist@partners.org



Responsible Party: Rebecca Suk Heist, MD, Massachusetts General Hospital
ClinicalTrials.gov Identifier: NCT01588821     History of Changes
Other Study ID Numbers: 12-091
First Submitted: April 26, 2012
First Posted: May 1, 2012
Results First Submitted: December 11, 2017
Results First Posted: January 10, 2018
Last Update Posted: January 10, 2018