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A Study of Vemurafenib (RO5185426) in Participants With Metastatic or Unresectable Papillary Thyroid Cancer Positive for the BRAF V600 Mutation

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Hoffmann-La Roche
ClinicalTrials.gov Identifier:
NCT01286753
First received: January 28, 2011
Last updated: July 22, 2016
Last verified: July 2016
Results First Received: July 22, 2016  
Study Type: Interventional
Study Design: Allocation: Non-Randomized;   Endpoint Classification: Safety/Efficacy Study;   Intervention Model: Parallel Assignment;   Masking: Open Label;   Primary Purpose: Treatment
Condition: Neoplasms
Intervention: Drug: Vemurafenib

  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
Written informed consent for participation in the study was obtained before performing any study-specific screening tests or evaluations.

Reporting Groups
  Description
Tyrosine Kinase Inhibitor (TKI) Naive Vemurafenib 960 milligrams (mg) orally twice daily in participants naive to any prior systemic TKI therapy.
TKI Experienced Vemurafenib 960 mg orally twice daily in participants previously treated with TKI therapy active against vascular endothelial growth factor receptor 2 (VEGFR).

Participant Flow:   Overall Study
    Tyrosine Kinase Inhibitor (TKI) Naive   TKI Experienced
STARTED   26   25 
COMPLETED   0   0 
NOT COMPLETED   26   25 
Adverse Event                7                6 
Progression                11                13 
Refused Treatment                1                0 
Withdrawal of Consent                0                2 
Discontinued to Join Extension Study                6                4 
Participant to Receive Radiotherapy                1                0 



  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.
Intent-to-Treat population, defined as all enrolled participants.

Reporting Groups
  Description
TKI Naive Vemurafenib 960 mg orally twice daily in participants naive to any prior systemic TKI therapy.
TKI Experienced Vemurafenib 960 mg orally twice daily in participants previously treated with TKI therapy active against VEGFR.
Total Total of all reporting groups

Baseline Measures
   TKI Naive   TKI Experienced   Total 
Overall Participants Analyzed 
[Units: Participants]
 26   25   51 
Age 
[Units: Years]
Mean (Standard Deviation)
 62.9  (13.5)   65.2  (9.1)   64.0  (11.5) 
Gender 
[Units: Participants]
     
Female   11   12   23 
Male   15   13   28 


  Outcome Measures
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1.  Primary:   Best Overall Response Rate in TKI-Naive Participants   [ Time Frame: Up to approximately 4 years ]

2.  Secondary:   Best Overall Response Rate in TKI-Experienced Participants   [ Time Frame: Up to approximately 4 years ]

3.  Secondary:   Clinical Benefit Rate   [ Time Frame: Up to approximately 4 years ]

4.  Secondary:   Duration of Response   [ Time Frame: From the date of first qualifying response to the date of PD or death for any cause (up to approximately 4 years) ]

5.  Secondary:   Progression-Free Survival   [ Time Frame: From the day of first treatment until the first documented PD or death (up to approximately 4 years) ]

6.  Secondary:   Overall Survival   [ Time Frame: From the date of first treatment to the date of death for any cause (up to approximately 4 years) ]

7.  Secondary:   Percentage of Participants With Adverse Events   [ Time Frame: Baseline until 28 days after the last dose of study treatment or until initiation of another anti-cancer therapy, whichever occurred first (up to approximately 4 years) ]

8.  Secondary:   Pharmacokinetics of Vemurafenib: Area Under the Concentration-Time Curve (AUC)   [ Time Frame: Up to approximately 4 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
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  More Information
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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: Medical Communications
Organization: Hoffmann-La Roche
phone: 800 821-8590
e-mail: genentech@druginfo.com



Responsible Party: Hoffmann-La Roche
ClinicalTrials.gov Identifier: NCT01286753     History of Changes
Other Study ID Numbers: NO25530
2010-024133-23
Study First Received: January 28, 2011
Results First Received: July 22, 2016
Last Updated: July 22, 2016
Health Authority: United States: Food and Drug Administration