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Cabozantinib (XL-184) Monotherapy for Advanced Cholangiocarcinoma

This study has been completed.
Sponsor:
Collaborator:
Exelixis
Information provided by (Responsible Party):
Goyal, Lipika, Massachusetts General Hospital
ClinicalTrials.gov Identifier:
NCT01954745
First received: September 24, 2013
Last updated: December 12, 2016
Last verified: December 2016
Results First Received: December 12, 2016  
Study Type: Interventional
Study Design: Intervention Model: Single Group Assignment;   Masking: Open Label;   Primary Purpose: Treatment
Conditions: Bile Duct Cancer
Intrahepatic Cholangiocarcinoma
Cholangiocarcinoma of the Extrahepatic Bile Duct
Intervention: Drug: Cabozantinib

  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
Cabozantinib

Patients will be treated with cabozantinib 60 mg daily administered orally continuously for 28-day cycles. Tumor assessments will be performed every 8 weeks until documented disease progression by RECIST criteria or drug intolerance.

Cabozantinib: Cabozantinib 60 mg (free base weight) per day will be administered daily and continuously for a cycle length of 28 days. Subjects will be provided with a sufficient supply of study treatment and instructions for taking the study treatment on days without scheduled clinic visits. After fasting (with exception of water) for 2 hours, subjects will take study treatment daily with a full glass of water (minimum of 8 oz/ 240 mL) and continue to fast for 1 hour after each dose of study treatment.


Participant Flow:   Overall Study
    Cabozantinib
STARTED   19 
COMPLETED   0 
NOT COMPLETED   19 
Radiological Progression                11 
Clinical Progression                5 
Adverse Event                2 
Death                1 



  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

Patients will be treated with cabozantinib 60 mg daily administered orally continuously for 28-day cycles. Tumor assessments will be performed every 8 weeks until documented disease progression by RECIST criteria or drug intolerance.

Cabozantinib: Cabozantinib 60 mg (free base weight) per day will be administered daily and continuously for a cycle length of 28 days. Subjects will be provided with a sufficient supply of study treatment and instructions for taking the study treatment on days without scheduled clinic visits. After fasting (with exception of water) for 2 hours, subjects will take study treatment daily with a full glass of water (minimum of 8 oz/ 240 mL) and continue to fast for 1 hour after each dose of study treatment.


Baseline Measures
   Cabozantinib 
Overall Participants Analyzed 
[Units: Participants]
 19 
Age 
[Units: Participants]
Count of Participants
 
<=18 years      0   0.0% 
Between 18 and 65 years      5  26.3% 
>=65 years      14  73.7% 
Age 
[Units: Years]
Median (Full Range)
 67 
 (45 to 74) 
Gender 
[Units: Participants]
Count of Participants
 
Female      13  68.4% 
Male      6  31.6% 
Region of Enrollment 
[Units: Participants]
 
United States   19 


  Outcome Measures
  Show All Outcome Measures

1.  Primary:   Median Progression Free Survival (PFS)   [ Time Frame: 2 Years ]

2.  Secondary:   Number of Patients With Adverse Events   [ Time Frame: 2 Years ]

3.  Secondary:   Objective Response Rate (ORR)   [ Time Frame: 2 Years ]

4.  Secondary:   Median Overall Survival (OS)   [ Time Frame: 2 years ]


  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
After 12 patients failed to be progression-free at 16 weeks, the study was terminated as it was determined that the criterion for proceeding to stage 2 could not be met. (i.e. 9 of 20 patients needed to be progression free at 4 months.)


  More Information
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Certain Agreements:  
Principal Investigators are NOT employed by the organization sponsoring the study.
There is NOT 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.


Results Point of Contact:  
Name/Title: Dr. Lipika Goyal
Organization: Massachusetts General Hospital Cancer Center
phone: 617-724-4000
e-mail: Lgoyal@partners.org



Responsible Party: Goyal, Lipika, Massachusetts General Hospital
ClinicalTrials.gov Identifier: NCT01954745     History of Changes
Other Study ID Numbers: 13-221
XL184-IST26 ( Other Identifier: Exelixis )
Study First Received: September 24, 2013
Results First Received: December 12, 2016
Last Updated: December 12, 2016