search
Back to results

Dabrafenib and/or Trametinib Rollover Study

Primary Purpose

Melanoma, Non Small Cell Lung Cancer, Solid Tumor

Status
Recruiting
Phase
Phase 4
Locations
International
Study Type
Interventional
Intervention
dabrafenib
trametinib
Sponsored by
Novartis Pharmaceuticals
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Melanoma focused on measuring Tafinlar, Mekinist, Dabrafenib, Trametinib, Adult, Melanoma, Melanoma Stage IV, Metastatic Melanoma, Advanced Melanoma, Lung Cancer, NSLC, Non Small Cell Lung Cancer, BRAF V600 Mutation, BRAF Gene Mutation, Solid tumor, Rare cancers, High Grade Glioma

Eligibility Criteria

18 Years - 100 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  • Patient is currently receiving treatment with dabrafenib/trametinib monotherapy or combination within a Novartis or former GSK sponsored study which has fulfilled the requirements for the primary objective.
  • In the opinion of the Investigator would benefit from continued treatment.

Exclusion Criteria:

  • Patient has been previously permanently discontinued from study treatment in the parent protocol.
  • Patient's indication is commercially available and reimbursed in the local country.
  • Patient currently has unresolved toxicities for which dabrafenib and/or trametinib dosing has been interrupted in the parent study.

Sites / Locations

  • Honor Health Research InstituteRecruiting
  • National Institute of HealthRecruiting
  • James Cancer Hospital and Solove Research Institute Ohio State
  • Mary Crowley Cancer Research
  • Novartis Investigative Site
  • Novartis Investigative Site
  • Novartis Investigative Site
  • Novartis Investigative Site
  • Novartis Investigative Site
  • Novartis Investigative Site
  • Novartis Investigative Site
  • Novartis Investigative Site
  • Novartis Investigative Site
  • Novartis Investigative Site
  • Novartis Investigative Site
  • Novartis Investigative Site
  • Novartis Investigative Site
  • Novartis Investigative Site
  • Novartis Investigative Site
  • Novartis Investigative Site
  • Novartis Investigative Site
  • Novartis Investigative Site
  • Novartis Investigative SiteRecruiting
  • Novartis Investigative SiteRecruiting
  • Novartis Investigative Site
  • Novartis Investigative SiteRecruiting
  • Novartis Investigative SiteRecruiting

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm Type

Experimental

Experimental

Experimental

Arm Label

dabrafenib monotherapy

trametinib monotherapy

Combination therapy (dabrafenib & trametinib)

Arm Description

Patients in this study may receive: - monotherapy of dabrafenib

Patients in this study may receive: - monotherapy of trametinib

Patients in this study may receive: - the combination of dabrafenib and trametinib

Outcomes

Primary Outcome Measures

Occurences of adverse events to evaluate long term safety and tolerability of dabrafenib, trametinib or combination
Clinical and laboratory assessments should be completed based on the local standard of care and physician practice for routine safety monitoring. More frequent examinations may be performed at the Investigator's discretion if medically indicated. Any abnormalities considered clinically significant, induce clinical signs or symptoms, or require changes in treatment constitute an adverse event.

Secondary Outcome Measures

Clinical Benefit Assessment by investigator
To evaluate clinical benefit as assessed by the Investigator

Full Information

First Posted
November 8, 2017
Last Updated
July 14, 2023
Sponsor
Novartis Pharmaceuticals
search

1. Study Identification

Unique Protocol Identification Number
NCT03340506
Brief Title
Dabrafenib and/or Trametinib Rollover Study
Official Title
Open Label, Multi-center Roll-over Study to Assess Long Term Safety in Patients Who Have Completed a Global Novartis or GSK Sponsored Dabrafenib and/or Trametinib Study
Study Type
Interventional

2. Study Status

Record Verification Date
July 2023
Overall Recruitment Status
Recruiting
Study Start Date
December 28, 2017 (Actual)
Primary Completion Date
December 20, 2027 (Anticipated)
Study Completion Date
December 21, 2027 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Novartis Pharmaceuticals

4. Oversight

Studies a U.S. FDA-regulated Drug Product
Yes
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

Brief Summary
This study is to provide access for patients who are receiving treatment with dabrafenib and/or trametinib in a Novartis-sponsored Oncology Global Development, Global Medical Affairs or a former GSK-sponsored study who have fulfilled the requirements for the primary objective, and who are judged by the investigator as benefiting from continued treatment in the parent study as judged by the Investigator at the completion of the parent study.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Melanoma, Non Small Cell Lung Cancer, Solid Tumor, Rare Cancers, High Grade Glioma
Keywords
Tafinlar, Mekinist, Dabrafenib, Trametinib, Adult, Melanoma, Melanoma Stage IV, Metastatic Melanoma, Advanced Melanoma, Lung Cancer, NSLC, Non Small Cell Lung Cancer, BRAF V600 Mutation, BRAF Gene Mutation, Solid tumor, Rare cancers, High Grade Glioma

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 4
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
Non-Randomized
Enrollment
100 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
dabrafenib monotherapy
Arm Type
Experimental
Arm Description
Patients in this study may receive: - monotherapy of dabrafenib
Arm Title
trametinib monotherapy
Arm Type
Experimental
Arm Description
Patients in this study may receive: - monotherapy of trametinib
Arm Title
Combination therapy (dabrafenib & trametinib)
Arm Type
Experimental
Arm Description
Patients in this study may receive: - the combination of dabrafenib and trametinib
Intervention Type
Drug
Intervention Name(s)
dabrafenib
Intervention Description
dabrafenib is available in capsules (50mg and 75mg) taken twice a day
Intervention Type
Drug
Intervention Name(s)
trametinib
Intervention Description
trametinib is available in tablets (0.5mg, 2mg dose)
Primary Outcome Measure Information:
Title
Occurences of adverse events to evaluate long term safety and tolerability of dabrafenib, trametinib or combination
Description
Clinical and laboratory assessments should be completed based on the local standard of care and physician practice for routine safety monitoring. More frequent examinations may be performed at the Investigator's discretion if medically indicated. Any abnormalities considered clinically significant, induce clinical signs or symptoms, or require changes in treatment constitute an adverse event.
Time Frame
Baseline up to approximately 10 years after the first subject's first visit, or will remain open until treatment becomes commercially available and reimbursed, or another access program becomes available, whichever comes first.
Secondary Outcome Measure Information:
Title
Clinical Benefit Assessment by investigator
Description
To evaluate clinical benefit as assessed by the Investigator
Time Frame
Baseline up to approximately 10 years after the first subject's first visit, or will remain open until treatment becomes commercially available and reimbursed, or another access program becomes available, whichever comes first.

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
100 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Patient is currently receiving treatment with dabrafenib/trametinib monotherapy or combination within a Novartis or former GSK sponsored study which has fulfilled the requirements for the primary objective. In the opinion of the Investigator would benefit from continued treatment. Exclusion Criteria: Patient has been previously permanently discontinued from study treatment in the parent protocol. Patient's indication is commercially available and reimbursed in the local country. Patient currently has unresolved toxicities for which dabrafenib and/or trametinib dosing has been interrupted in the parent study.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Novartis Pharmaceuticals
Phone
1-888-669-6682
Email
Novartis.email@novartis.com
First Name & Middle Initial & Last Name or Official Title & Degree
Novartis Pharmaceuticals
Phone
+41613241111
Facility Information:
Facility Name
Honor Health Research Institute
City
Scottsdale
State/Province
Arizona
ZIP/Postal Code
85258
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Angela Neuckranz
Phone
480-323-3990
Email
Angela.Neuckranz@HonorHealth.com
First Name & Middle Initial & Last Name & Degree
Michael Gordon
Facility Name
National Institute of Health
City
Bethesda
State/Province
Maryland
ZIP/Postal Code
20892
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Michelle Capozzoli
Phone
9999
Email
michelle.capozzoli@nih.gov
First Name & Middle Initial & Last Name & Degree
Robert Kreitman
Facility Name
James Cancer Hospital and Solove Research Institute Ohio State
City
Columbus
State/Province
Ohio
ZIP/Postal Code
43210
Country
United States
Individual Site Status
Completed
Facility Name
Mary Crowley Cancer Research
City
Dallas
State/Province
Texas
ZIP/Postal Code
75251
Country
United States
Individual Site Status
Completed
Facility Name
Novartis Investigative Site
City
Buenos Aires
ZIP/Postal Code
C1125ABE
Country
Argentina
Individual Site Status
Completed
Facility Name
Novartis Investigative Site
City
Innsbruck
ZIP/Postal Code
A-6020
Country
Austria
Individual Site Status
Active, not recruiting
Facility Name
Novartis Investigative Site
City
Beijing
ZIP/Postal Code
100036
Country
China
Individual Site Status
Active, not recruiting
Facility Name
Novartis Investigative Site
City
Copenhagen
ZIP/Postal Code
DK-2100
Country
Denmark
Individual Site Status
Active, not recruiting
Facility Name
Novartis Investigative Site
City
Lyon
ZIP/Postal Code
69373
Country
France
Individual Site Status
Active, not recruiting
Facility Name
Novartis Investigative Site
City
Nantes Cedex 1
ZIP/Postal Code
44093
Country
France
Individual Site Status
Active, not recruiting
Facility Name
Novartis Investigative Site
City
Paris
ZIP/Postal Code
75970
Country
France
Individual Site Status
Completed
Facility Name
Novartis Investigative Site
City
Villejuif Cedex
ZIP/Postal Code
94800
Country
France
Individual Site Status
Active, not recruiting
Facility Name
Novartis Investigative Site
City
Mannheim
State/Province
Baden-Wuerttemberg
ZIP/Postal Code
68305
Country
Germany
Individual Site Status
Active, not recruiting
Facility Name
Novartis Investigative Site
City
Berlin
ZIP/Postal Code
13353
Country
Germany
Individual Site Status
Completed
Facility Name
Novartis Investigative Site
City
Hamburg
ZIP/Postal Code
20246
Country
Germany
Individual Site Status
Active, not recruiting
Facility Name
Novartis Investigative Site
City
Heidelberg
ZIP/Postal Code
69120
Country
Germany
Individual Site Status
Active, not recruiting
Facility Name
Novartis Investigative Site
City
Budapest
ZIP/Postal Code
H 1122
Country
Hungary
Individual Site Status
Completed
Facility Name
Novartis Investigative Site
City
Debrecen
ZIP/Postal Code
4032
Country
Hungary
Individual Site Status
Active, not recruiting
Facility Name
Novartis Investigative Site
City
Kashiwa
State/Province
Chiba
ZIP/Postal Code
277 8577
Country
Japan
Individual Site Status
Active, not recruiting
Facility Name
Novartis Investigative Site
City
Chuo ku
State/Province
Tokyo
ZIP/Postal Code
104 0045
Country
Japan
Individual Site Status
Active, not recruiting
Facility Name
Novartis Investigative Site
City
Rotterdam
ZIP/Postal Code
3075 EA
Country
Netherlands
Individual Site Status
Active, not recruiting
Facility Name
Novartis Investigative Site
City
Utrecht
ZIP/Postal Code
3584CX
Country
Netherlands
Individual Site Status
Active, not recruiting
Facility Name
Novartis Investigative Site
City
Barcelona
State/Province
Catalunya
ZIP/Postal Code
08035
Country
Spain
Individual Site Status
Recruiting
Facility Name
Novartis Investigative Site
City
Madrid
ZIP/Postal Code
28040
Country
Spain
Individual Site Status
Recruiting
Facility Name
Novartis Investigative Site
City
Madrid
ZIP/Postal Code
28041
Country
Spain
Individual Site Status
Completed
Facility Name
Novartis Investigative Site
City
Madrid
ZIP/Postal Code
28050
Country
Spain
Individual Site Status
Recruiting
Facility Name
Novartis Investigative Site
City
Songkla
ZIP/Postal Code
90110
Country
Thailand
Individual Site Status
Recruiting

12. IPD Sharing Statement

Plan to Share IPD
Undecided

Learn more about this trial

Dabrafenib and/or Trametinib Rollover Study

We'll reach out to this number within 24 hrs