Dabrafenib and/or Trametinib Rollover Study

  • STATUS
    Recruiting
  • End date
    Dec 21, 2027
  • participants needed
    100
  • sponsor
    Novartis Pharmaceuticals
Updated on 28 October 2021
trametinib
dabrafenib

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.

Details
Condition Non-Small Cell Lung Cancer, melanoma, skin cancer, Metastatic Melanoma, Solid Tumors, Solid Tumor, High Grade Glioma, Solid Neoplasm, Solid Tumour, Rare Cancers, Malignant Melanoma, malignant glioma, nsclc
Treatment Dabrafenib, Trametinib
Clinical Study IdentifierNCT03340506
SponsorNovartis Pharmaceuticals
Last Modified on28 October 2021

Eligibility

Yes No Not Sure

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
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How to participate?

Step 1 Connect with a study center
What happens next?
  • You can expect the study team to contact you via email or phone in the next few days.
  • Sign up as volunteer to help accelerate the development of new treatments and to get notified about similar trials.

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Additional screening procedures may be conducted by the study team before you can be confirmed eligible to participate.

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If you are confirmed eligible after full screening, you will be required to understand and sign the informed consent if you decide to enroll in the study. Once enrolled you may be asked to make scheduled visits over a period of time.

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Complete your scheduled study participation activities and then you are done. You may receive summary of study results if provided by the sponsor.

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