We are updating the design of this site. Learn more.
Show more
ClinicalTrials.gov
ClinicalTrials.gov Menu

Efficacy of XL184 (Cabozantinib) in Advanced Medullary Thyroid Cancer (EXAM)

The recruitment status of this study is unknown. The completion date has passed and the status has not been verified in more than two years.
Verified August 2015 by Exelixis.
Recruitment status was:  Active, not recruiting
Sponsor:
ClinicalTrials.gov Identifier:
NCT00704730
First Posted: June 25, 2008
Last Update Posted: August 27, 2015
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.
Information provided by (Responsible Party):
Exelixis
Results First Submitted: April 8, 2014  
Study Type: Interventional
Study Design: Allocation: Randomized;   Intervention Model: Parallel Assignment;   Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor);   Primary Purpose: Treatment
Condition: Thyroid Cancer
Interventions: Drug: XL184
Drug: Placebo

  Participant Flow
  Hide Participant Flow

Recruitment Details
Key information relevant to the recruitment process for the overall study, such as dates of the recruitment period and locations
First patient enrolled 10 September 2008, last patient enrolled 27 February 2011. Data cut off date 15 June 2011.

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
XL184 (Cabozantinib) XL184 175 mg L-malate salt weight; 138 mg freebase equivalent weight, oral capsules once daily
Placebo oral capsules once daily

Participant Flow:   Overall Study
    XL184 (Cabozantinib)   Placebo
STARTED   219 [1]   111 [1] 
COMPLETED   98 [2]   15 [2] 
NOT COMPLETED   121   96 
Adverse Event                35                9 
Death                11                5 
Physician Decision                2                0 
Did not receive drug                5                2 
Disease progression per PI                58                67 
data unavailable                1                0 
Withdrawal by Subject                9                13 
[1] Randomized
[2] Continuing study treatment at the time of data cut-off.



  Baseline Characteristics
  Hide 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
XL184 (Cabozantinib) XL184 175 mg L-malate salt weight; 138 mg freebase equivalent weight, oral capsules once daily
Placebo oral capsules once daily
Total Total of all reporting groups

Baseline Measures
   XL184 (Cabozantinib)   Placebo   Total 
Overall Participants Analyzed 
[Units: Participants]
 219   111   330 
Age 
[Units: Participants]
     
<=18 years   0   0   0 
Between 18 and 65 years   172   86   258 
>=65 years   47   25   72 
Age 
[Units: Years]
Mean (Standard Deviation)
 54.4  (13.33)   53.8  (13.39)   54.2  (13.33) 
Gender 
[Units: Participants]
     
Female   68   41   109 
Male   151   70   221 
Region of Enrollment 
[Units: Participants]
     
Austria   8   1   9 
Belgium   7   5   12 
Brazil   4   3   7 
Canada   6   2   8 
Chile   0   1   1 
Denmark   1   0   1 
France   25   5   30 
Germany   15   10   25 
Greece   1   2   3 
Portugal   0   1   1 
India   5   1   6 
Israel   5   4   9 
Italy   28   14   42 
Korea, Republic of   3   4   7 
Netherlands   5   3   8 
Peru   1   0   1 
Poland   12   3   15 
Russian Federation   8   5   13 
Spain   5   3   8 
Switzerland   1   0   1 
Sweden   6   4   10 
United Kingdom   10   9   19 
United States   63   31   94 


  Outcome Measures
  Show All Outcome Measures

1.  Primary:   Progression-Free Survival (PFS)   [ Time Frame: Treatment period consisted of 4-week cycles with radiologic tumor assessment every 12 weeks from date of randomization until date of first documented PD or date of death from any cause, whichever came first, assessed up to 34 months. ]

2.  Secondary:   Overall Survival (OS) With XL184 Compared With Placebo   [ Time Frame: The pre-specified interim analysis of Overall Survival (OS) was assessed at 44% of required events. Includes data up to 15June2011. As of this date, the number of deaths required to conduct the primary analysis had not been reached. ]

3.  Secondary:   Objective Response Rate (ORR)   [ Time Frame: Assessed at the same time as primary analysis of Progression Free Survival (PFS) data. Assessed at baseline and every 12 weeks until Progressive Disease (PD) up to 34 months. ]

4.  Secondary:   Duration of Objective Response (OR): Independent Radiology Committee (IRC) Determined   [ Time Frame: From time of first documentation of Objective Response (OR), confirmed at a later visit ≥28 days later as Progressive Disease (PD) as defined by mRECIST or death due to any cause, assessed up to 34 months. ]

5.  Secondary:   Biochemical Response Calcitonin (CTN) %   [ Time Frame: Serum tumor markers CTN evaluated from blood samples collected at screening and every 12 weeks (±5 days from randomization) until date of first documented progression or date of death from any cause, whichever came first, assessed for up to 34 months. ]

6.  Secondary:   Biochemical Response Carcinoembryonic Antigen (CEA) %   [ Time Frame: Serum tumor markers CEA evaluated from blood samples collected at screening and every 12 weeks (± 5 days from randomization) until date of first documented progression or date of death from any cause, whichever came first, assessed for up to 34 months. ]


  Serious Adverse Events


  Other Adverse Events


  Limitations and Caveats
  Hide 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
  Hide 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 less than or equal to 60 days. The sponsor cannot require changes to the communication and cannot extend the embargo.
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.


Results Point of Contact:  
Name/Title: Yifah Yaron, MD Senior Director, Clinical Research, Clinical Development
Organization: Exelixis, Inc
phone: 650-837-7678
e-mail: yyaron@exelixis.com


Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

Responsible Party: Exelixis
ClinicalTrials.gov Identifier: NCT00704730     History of Changes
Other Study ID Numbers: XL184-301
First Submitted: June 23, 2008
First Posted: June 25, 2008
Results First Submitted: April 8, 2014
Results First Posted: September 9, 2014
Last Update Posted: August 27, 2015