This site became the new ClinicalTrials.gov on June 19th. Learn more.
Show more
ClinicalTrials.gov Menu IMPORTANT: Listing of a study on this site does not reflect endorsement by the National Institutes of Health. Talk with a trusted healthcare professional before volunteering for a study. Read more...
ClinicalTrials.gov Menu IMPORTANT: Talk with a trusted healthcare professional before volunteering for a study. Read more...
ClinicalTrials.gov Menu
Give us feedback

Dabrafenib Alone and in Combination With Trametinib Before Surgery in Treating Patients With Locally or Regionally Advanced Melanoma That Can Be Removed By Surgery

This study has been terminated.
(PI leaving VICC, low future accrual predicted, continued funding improbable,)
Sponsor:
Collaborators:
National Cancer Institute (NCI)
National Comprehensive Cancer Network
Information provided by (Responsible Party):
Mark Kelley, MD, Vanderbilt-Ingram Cancer Center
ClinicalTrials.gov Identifier:
NCT01701037
First received: September 21, 2012
Last updated: June 20, 2017
Last verified: June 2017
Results First Received: March 10, 2017  
Study Type: Interventional
Study Design: Intervention Model: Single Group Assignment;   Masking: None (Open Label);   Primary Purpose: Other
Conditions: Recurrent Melanoma
Stage IIB Melanoma (Locally Advanced)
Stage IIC Melanoma (Locally Advanced)
Stage IIIA Melanoma
Stage IIIB Melanoma
Stage IIIC Melanoma
Stage IV Melanoma (Limited, Resectable)
Interventions: Drug: dabrafenib
Drug: trametinib
Other: laboratory biomarker analysis

  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
This study opened to accrual at Vanderbilt-Ingram Cancer Center (VICC) in January 2013 and ran through March 2015 when it closed prematurely due to PI's departure.

Pre-Assignment Details
Significant events and approaches for the overall study following participant enrollment, but prior to group assignment
Thirteen patients participated in this study, all completed the study as defined by protocol.

Reporting Groups
  Description
Basic Science (Dabrafenib, Trametinib)

Patients receive dabrafenib PO BID on days 1-28 adding trametinib on days 15-28 followed by surgery on days 28-30. Treatment continues in the absence of unacceptable toxicity.

dabrafenib: 150 mg given PO

trametinib: 2 mg given PO

laboratory biomarker analysis: Correlative studies


Participant Flow:   Overall Study
    Basic Science (Dabrafenib, Trametinib)
STARTED   13 
COMPLETED   13 
NOT COMPLETED   0 



  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
Basic Science (Dabrafenib, Trametinib)

Patients receive dabrafenib PO BID on days 1-28 adding trametinib on days 15-28 followed by surgery on days 28-30. Treatment continues in the absence of unacceptable toxicity.

dabrafenib: 150 mg given PO

trametinib: 2 mg given PO

laboratory biomarker analysis: Correlative studies


Baseline Measures
   Basic Science (Dabrafenib, Trametinib) 
Overall Participants Analyzed 
[Units: Participants]
 13 
Age, Customized 
[Units: Participants]
Count of Participants
 
20-29   1 
30-39   2 
40-49   2 
50-59   3 
60-69   3 
70-79   2 
Sex: Female, Male 
[Units: Participants]
Count of Participants
 
Female      7  53.8% 
Male      6  46.2% 
Ethnicity (NIH/OMB) 
[Units: Participants]
Count of Participants
 
Hispanic or Latino      0   0.0% 
Not Hispanic or Latino      13 100.0% 
Unknown or Not Reported      0   0.0% 
Race (NIH/OMB) 
[Units: Participants]
Count of Participants
 
American Indian or Alaska Native      0   0.0% 
Asian      0   0.0% 
Native Hawaiian or Other Pacific Islander      0   0.0% 
Black or African American      0   0.0% 
White      13 100.0% 
More than one race      0   0.0% 
Unknown or Not Reported      0   0.0% 
Region of Enrollment 
[Units: Participants]
Count of Participants
 
United States   13 


  Outcome Measures
  Show All Outcome Measures

1.  Primary:   Clinical Tumor Response Rate (Response is Based on Greater Than 30% Reduction From Baseline in Tumor Volume by RECIST Criteria) at Day 14.   [ Time Frame: day 14 ]

2.  Secondary:   Change in Tumor Volume Reduction in Participants With Intrinsic Resistance to B-RAF Targeted Therapy From Day 14 to Day 28.   [ Time Frame: Day 14 and day 28 ]

3.  Secondary:   Number of Patients With Worst Grade Toxicities by Grade According to National Cancer Institute (NCI) CTCAE Version 4.0   [ Time Frame: Up to 3 months ]

4.  Secondary:   Investigational Agent Taken   [ Time Frame: Up to 3 months ]

5.  Secondary:   Percent of Patients Completing Second and Third (Surgical) Biopsies   [ Time Frame: Up to 3 months ]

6.  Secondary:   Percentage of Biopsies With Adequate Tissue for Biomarker Analysis   [ Time Frame: Up to 3 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:  
All Principal Investigators ARE employed by the organization sponsoring the study.


Results Point of Contact:  
Name/Title: Mark C. Kelley
Organization: Vanderbilt-Ingram Cancer Center
phone: 615-936-7423
e-mail: mark.kelley@vanderbilt.edu


Publications of Results:

Responsible Party: Mark Kelley, MD, Vanderbilt-Ingram Cancer Center
ClinicalTrials.gov Identifier: NCT01701037     History of Changes
Other Study ID Numbers: VICC MEL 1263
NCI-2012-01699 ( Registry Identifier: CTRP (Clinical Trial Reporting Program) )
Study First Received: September 21, 2012
Results First Received: March 10, 2017
Last Updated: June 20, 2017