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Trial record 1 of 1 for:    NCT01811212
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Cabozantinib-S-Malate in Treating Patients With Refractory Thyroid Cancer

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ClinicalTrials.gov Identifier: NCT01811212
Recruitment Status : Completed
First Posted : March 14, 2013
Results First Posted : April 3, 2018
Last Update Posted : April 3, 2018
Sponsor:
Collaborator:
Exelixis
Information provided by (Responsible Party):
National Cancer Institute (NCI)

Study Type: Interventional
Study Design: Intervention Model: Single Group Assignment;   Masking: None (Open Label);   Primary Purpose: Treatment
Conditions: Poorly Differentiated Thyroid Gland Carcinoma
Recurrent Thyroid Gland Carcinoma
Stage I Thyroid Gland Follicular Carcinoma
Stage I Thyroid Gland Papillary Carcinoma
Stage II Thyroid Gland Follicular Carcinoma
Stage II Thyroid Gland Papillary Carcinoma
Stage III Thyroid Gland Follicular Carcinoma
Stage III Thyroid Gland Papillary Carcinoma
Stage IVA Thyroid Gland Follicular Carcinoma
Stage IVA Thyroid Gland Papillary Carcinoma
Stage IVB Thyroid Gland Follicular Carcinoma
Stage IVB Thyroid Gland Papillary Carcinoma
Stage IVC Thyroid Gland Follicular Carcinoma
Stage IVC Thyroid Gland Papillary Carcinoma
Tall Cell Variant Thyroid Gland Papillary Carcinoma
Thyroid Gland Oncocytic Follicular Carcinoma
Interventions: Drug: Cabozantinib S-malate
Other: Laboratory Biomarker Analysis

  Participant Flow

Recruitment Details
Key information relevant to the recruitment process for the overall study, such as dates of the recruitment period and locations
Between September 2013 and January 2015 patients were enrolled by ITOG investigators at six centers in the United States.

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 (Cabozantinib-s-malate) Patients receive Cabozantinib 60mg PO QD with dose escalation to 80mg QD or dose reduction to 40mg daily or 20mg. Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity.

Participant Flow:   Overall Study
    Treatment (Cabozantinib-s-malate)
STARTED   25 
COMPLETED   25 
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
Treatment (Cabozantinib-s-malate) Patients receive Cabozantinib 60mg PO QD with dose escalation to 80mg QD or dose reduction to 40mg daily or 20mg. Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity.

Baseline Measures
   Treatment (Cabozantinib-s-malate) 
Overall Participants Analyzed 
[Units: Participants]
 25 
Age 
[Units: Years]
Median (Full Range)
 64 
 (41 to 81) 
Sex: Female, Male 
[Units: Participants]
Count of Participants
 
Female      9  36.0% 
Male      16  64.0% 
Race (NIH/OMB) 
[Units: Participants]
Count of Participants
 
American Indian or Alaska Native      0   0.0% 
Asian      3  12.0% 
Native Hawaiian or Other Pacific Islander      0   0.0% 
Black or African American      1   4.0% 
White      21  84.0% 
More than one race      0   0.0% 
Unknown or Not Reported      0   0.0% 
Region of Enrollment 
[Units: Participants]
Count of Participants
 
United States   25 


  Outcome Measures

1.  Primary:   Objective Response Rate, Defined as the Proportion of Patients Who Have Had a PR or CR as Assessed by the RECIST Version (v)1.1   [ Time Frame: Up to 6 months ]

2.  Secondary:   Bone Turnover, as Measured by Serum and Urinary Markers of Bone Turnover   [ Time Frame: Up to 2 months ]

3.  Secondary:   Duration of Objective Response as Assessed by the RECIST v1.1   [ Time Frame: From date of documentation of response to the date of progression or death, assessed up to 1 year ]

4.  Secondary:   Expression Levels of Predictive Biomarkers of Response by Immunohistochemistry in Archived Tumor Tissue   [ Time Frame: Baseline ]

5.  Secondary:   Genotype of Biomarkers Potentially Predictive of Response   [ Time Frame: Baseline ]

6.  Secondary:   Incidence of Severe (Grade 3+) Adverse Events, Graded According to the National Cancer Institute CTCAE v4.0   [ Time Frame: Up to 1 year ]

7.  Secondary:   Overall Survival   [ Time Frame: Time from start of treatment to time of death, assessed up to 1 year ]

8.  Secondary:   Percent Change in Serum Tumor Marker Thyroglobulin Levels   [ Time Frame: Baseline to 6 months ]

9.  Secondary:   Progression-free Survival   [ Time Frame: Time from start of treatment to time of progression or death, whichever occurs first, assessed up to 1 year ]

10.  Secondary:   Response of Cabozantinib-s-malate in Bone Metastasis (Bone Metastasis-specific Progression Free Survival) as Evaluated by Functional Imaging   [ Time Frame: Up to 2 months ]


  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:  
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: Manisha Shah, MD
Organization: The Ohio State University Compreshive Cancer Center
phone: 614-366-6994
e-mail: manisha.shah@osumc.edu


Publications of Results:

Responsible Party: National Cancer Institute (NCI)
ClinicalTrials.gov Identifier: NCT01811212     History of Changes
Other Study ID Numbers: NCI-2013-00554
NCI-2013-00554 ( Registry Identifier: CTRP (Clinical Trial Reporting Program) )
2012C0101
RU241210I
OSU 12154
9312 ( Other Identifier: Ohio State University Comprehensive Cancer Center )
9312 ( Other Identifier: CTEP )
N01CM00039 ( U.S. NIH Grant/Contract )
N01CM00070 ( U.S. NIH Grant/Contract )
N01CM00071 ( U.S. NIH Grant/Contract )
N01CM00099 ( U.S. NIH Grant/Contract )
P30CA016058 ( U.S. NIH Grant/Contract )
UM1CA186705 ( U.S. NIH Grant/Contract )
First Submitted: March 12, 2013
First Posted: March 14, 2013
Results First Submitted: December 11, 2017
Results First Posted: April 3, 2018
Last Update Posted: April 3, 2018