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Recruiting NCT03340506

Dabrafenib and/or Trametinib Rollover Study

Phase IV Interventional Melanoma Non Small Cell Lung Cancer Solid Tumor Rare Cancers

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: dabrafenib, trametinib.
Who it may be relevant to
Registry conditions: Melanoma, Non Small Cell Lung Cancer, Solid Tumor, Rare Cancers. Basic parameters: 18 years — 100 years · All.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
United States, Argentina, Austria, China, Denmark +7
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →

Unsure about the terms? Read our patient guide →

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

Overview

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.

Interventions

  • Drug dabrafenib
    dabrafenib is available in capsules (50mg and 75mg) taken twice a day
  • Drug trametinib
    trametinib is available in tablets (0.5mg, 2mg dose)

Primary outcome measures

  • Occurences of adverse events to evaluate long term safety and tolerability of dabrafenib, trametinib or combination [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 measures (1)
  • Clinical Benefit Assessment by 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.]

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.

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Allocation
Non-randomized
Model
Single group
Masking
Open label
Primary purpose
Treatment

Study locations

Germany · 6 centers
  • Novartis Investigative Site — Mannheim
  • Novartis Investigative Site — Berlin
  • Novartis Investigative Site — Essen
  • Novartis Investigative Site — Hamburg
  • Novartis Investigative Site — Hamburg
  • Novartis Investigative Site — Heidelberg
Spain · 6 centers
  • Novartis Investigative Site — Barcelona
  • Novartis Investigative Site — Madrid
  • Novartis Investigative Site — Madrid
  • Novartis Investigative Site — Madrid
  • Novartis Investigative Site — Madrid
  • Novartis Investigative Site — Valencia
France · 5 centers
  • Novartis Investigative Site — Lyon
  • Novartis Investigative Site — Nantes
  • Novartis Investigative Site — Paris
  • Novartis Investigative Site — Paris
  • Novartis Investigative Site — Villejuif
United States · 4 centers
  • Honor Health Research Institute — Scottsdale
  • National Institute Of Health — Bethesda
  • James Cancer Hospital and Solove Research Institute Ohio State — Columbus
  • Mary Crowley Cancer Research — Dallas
Hungary · 2 centers
  • Novartis Investigative Site — Debrecen
  • Novartis Investigative Site — Budapest
Japan · 2 centers
  • Novartis Investigative Site — Kashiwa
  • Novartis Investigative Site — Chuo Ku
Netherlands · 2 centers
  • Novartis Investigative Site — Rotterdam
  • Novartis Investigative Site — Utrecht
Argentina · 1 center
  • Novartis Investigative Site — Caba
Austria · 1 center
  • Novartis Investigative Site — Innsbruck
China · 1 center
  • Novartis Investigative Site — Beijing
Denmark · 1 center
  • Novartis Investigative Site — Copenhagen
Thailand · 1 center
  • Novartis Investigative Site — Songkhla

Identifiers

NCT: NCT03340506 · CDRB436X2X02B · 2023-509318-13-00

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗