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Dabrafenib and/or Trametinib Rollover Study

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ClinicalTrials.gov Identifier: NCT03340506
Recruitment Status : Recruiting
First Posted : November 13, 2017
Last Update Posted : July 17, 2018
Sponsor:
Information provided by (Responsible Party):
Novartis ( Novartis Pharmaceuticals )

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 n the parent study as judged by the Investigator at the completion of the parent study.

Condition or disease Intervention/treatment Phase
Melanoma Non Small Cell Lung Cancer Solid Tumor Rare Cancers High Grade Glioma Drug: dabrafenib Drug: trametinib Phase 4

Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 100 participants
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
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
Actual Study Start Date : December 28, 2017
Estimated Primary Completion Date : July 17, 2023
Estimated Study Completion Date : July 17, 2023


Arm Intervention/treatment
Experimental: dabrafenib and/or trametinib

Patients in this study may receive one of the following treatments received in the parent study which are:

  • Patients who received monotherapy of either of dabrafenib or trametinib solid dose forms
  • Patients who received combination of dabrafenib and trametinib solid dose forms
  • Patients who received suspensions of dabrafenib and/or trametinib
Drug: dabrafenib
dabrafenib is available in capsules (50mg and 75mg) as well as in powder form for Oral Suspension (10 mg/mL dose) and taken twice a day

Drug: trametinib
trametinib is available in tablet (0.125mg, 0.5mg, 2mg dose) as well as in powder form for Oral Solution (0.05mg/mL dose




Primary Outcome Measures :
  1. Occurences of adverse events to evaluate long term safety and tolerability of dabrafenib, trametinib or combination [ Time Frame: Baseline up to approximately 5 years ]
    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, require concomitant therapy or require changes in treatment constitute an adverse event.


Secondary Outcome Measures :
  1. Clinical Benefit Assessment by investigator [ Time Frame: Baseline up to approximately 5 years ]
    To evaluate clinical benefit as assessed by the Investigator



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Ages Eligible for Study:   Child, Adult, Older Adult
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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 has participated in a combination trial where dabrafenib and/or trametinib was dispensed in combination with another study medication.
  • Patient currently has unresolved toxicities for which dabrafenib and/or trametinib dosing has been interrupted in the parent study.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03340506


Contacts
Contact: Novartis Pharmaceuticals 1-888-669-6682 Novartis.email@novartis.com
Contact: Novartis Pharmaceuticals +41613241111

Locations
United States, Arizona
Honor Health Research Institute Recruiting
Scottsdale, Arizona, United States, 85258
Contact: Kristina Will    623-238-7671    Kristina.Will@honorhealth.com   
Principal Investigator: Michael Gordon         
United States, Ohio
James Cancer Hospital & Solove Research Institute-Ohio State Recruiting
Columbus, Ohio, United States, 43210
Contact: Tomasina Wall    614-366-7421    Tomasina.Wall@osumc.edu   
Principal Investigator: Kari L. Kendra         
United States, Texas
Mary Crowley Research Center Recruiting
Dallas, Texas, United States, 75251
Contact: Christy Lacy    214-658-1941    clacy@marycrowley.org   
Principal Investigator: Minal Barve         
France
Novartis Investigative Site Recruiting
Paris, France, 75970
Spain
Novartis Investigative Site Recruiting
Barcelona, Catalunya, Spain, 08035
Novartis Investigative Site Recruiting
Madrid, Spain, 28040
Novartis Investigative Site Recruiting
Madrid, Spain, 28050
Sponsors and Collaborators
Novartis Pharmaceuticals

Responsible Party: Novartis Pharmaceuticals
ClinicalTrials.gov Identifier: NCT03340506     History of Changes
Other Study ID Numbers: CDRB436X2X02B
First Posted: November 13, 2017    Key Record Dates
Last Update Posted: July 17, 2018
Last Verified: July 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided

Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No

Keywords provided by Novartis ( Novartis Pharmaceuticals ):
Solid tumor
Tafinlar
Mekinist
Dabrafenib
Trametinib
Adult
Pediatric
Melanoma
Melanoma Stage IV
Metastatic Melanoma
Advanced Melanoma
Lung Cancer
NSLC
Non Small Cell Lung Cancer
BRAF V600 Mutation
BRAF Gene Mutation
Rare cancers
High Grade Glioma

Additional relevant MeSH terms:
Lung Neoplasms
Carcinoma, Non-Small-Cell Lung
Melanoma
Glioma
Respiratory Tract Neoplasms
Thoracic Neoplasms
Neoplasms by Site
Neoplasms
Lung Diseases
Respiratory Tract Diseases
Carcinoma, Bronchogenic
Bronchial Neoplasms
Neuroendocrine Tumors
Neuroectodermal Tumors
Neoplasms, Germ Cell and Embryonal
Neoplasms by Histologic Type
Neoplasms, Nerve Tissue
Nevi and Melanomas
Neoplasms, Neuroepithelial
Neoplasms, Glandular and Epithelial
Trametinib
Dabrafenib
Antineoplastic Agents
Protein Kinase Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action