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Dabrafenib and Trametinib With Radiosurgery in Melanoma Brain Mets

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ClinicalTrials.gov Identifier: NCT01721603
Recruitment Status : Terminated (Low accrual)
First Posted : November 6, 2012
Results First Posted : January 23, 2018
Last Update Posted : January 23, 2018
Sponsor:
Collaborator:
GlaxoSmithKline
Information provided by (Responsible Party):
Alain Algazi, University of California, San Francisco

Study Type: Interventional
Study Design: Intervention Model: Single Group Assignment;   Masking: None (Open Label);   Primary Purpose: Treatment
Condition: BRAFV600E Melanoma Patients
Interventions: Drug: Dabrafenib
Procedure: Gamma Knife Radiosurgery
Drug: Trametinib

  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
Dabrafenib + Trametinib + Gamma Knife Radiosurgery

1 cycle = 28 days

  • Dabrafenib: 150mg capsule by mouth (PO), twice daily, continuous
  • Trametinib: 2 mg PO, once daily from beginning of cycle 3 Day 1,until progression of disease, withdrawal of consent, or the development of intolerable treatment associated toxicity.

For patients with stable disease or partial tumor responses in the brain, Gamma Knife radiosurgery will be performed on treatment cycle 2, day 1 (+/- 3 days) using a stereotactic head frame and MRI imaging in accordance with FDA-approved procedures.


Participant Flow:   Overall Study
    Dabrafenib + Trametinib + Gamma Knife Radiosurgery
STARTED   2 
COMPLETED   2 
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.
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Reporting Groups
  Description
Dabrafenib Given in Combination With Gamma Knife Radiosurgery

All patients will receive continuous, oral dosing of dabrafenib at a starting dose of 150 mg twice daily until progression of disease, withdrawal of consent, or the development of intolerable treatment associated toxicity

Dabrafenib: 150mg capsule by mouth twice daily

Gamma Knife Radiosurgery: This will be delivered using Gamma Knife technology. Patients will be fitted with a stereotactic head-frame for stereotactic localization of brain metastases.


Baseline Measures
   Dabrafenib Given in Combination With Gamma Knife Radiosurgery 
Overall Participants Analyzed 
[Units: Participants]
 2 
Age 
[Units: Participants]
Count of Participants
 
<=18 years      0   0.0% 
Between 18 and 65 years      2 100.0% 
>=65 years      0   0.0% 
Sex: Female, Male 
[Units: Participants]
Count of Participants
 
Female      1  50.0% 
Male      1  50.0% 
Region of Enrollment 
[Units: Participants]
 
United States   2 


  Outcome Measures

1.  Primary:   Patients Reaching 6 Month Distant Brain Metastasis-free Survival (DBMFS)   [ Time Frame: Up to 6 months after surgery ]

2.  Secondary:   Patients Displaying 6-month Local Control Rate   [ Time Frame: From surgery up to 6 months ]

3.  Secondary:   Best Overall Response Rate (by RECIST v1.1 )   [ Time Frame: From surgery up to 12 months ]

4.  Secondary:   Median Duration of Freedom From New Brain Metastases( by RECIST v1.1 )   [ Time Frame: From surgery up to 12 months ]

5.  Secondary:   Median Time to Progression   [ Time Frame: From surgery up to 12 months ]

6.  Secondary:   Systemic Overall Response Rate   [ Time Frame: From surgery up to 12 months ]

7.  Secondary:   Median Progression-free Survival   [ Time Frame: From surgery up to 12 months ]

8.  Secondary:   Median Overall Survival   [ Time Frame: From surgery up to 12 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
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  More Information

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


Results Point of Contact:  
Name/Title: Alain Algazi, MD
Organization: University of California, San Francisco
phone: (415) 353-7552
e-mail: Alain.Algazi@ucsf.edu


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

Responsible Party: Alain Algazi, University of California, San Francisco
ClinicalTrials.gov Identifier: NCT01721603     History of Changes
Other Study ID Numbers: 12857
First Submitted: November 1, 2012
First Posted: November 6, 2012
Results First Submitted: December 19, 2017
Results First Posted: January 23, 2018
Last Update Posted: January 23, 2018