Recruiting PHASE4 Melanoma

New treatment option for Melanoma

Official title Dabrafenib and/or Trametinib Rollover Study

ClinicalTrials.gov ID: NCT03340506

What this study is testing

What is dabrafenib?

dabrafenib is an investigational medicine, given as a twice-daily pill taken by mouth, being studied as a potential treatment for melanoma.

Plain-language explanation of the investigational treatment - it is being studied and is not an approved or proven therapy. The study team can confirm the details.

What it's testing
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.
  • Phase 4: studies an already-approved treatment

A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.

Who can take part

Ages 18 to 100

You may be able to join if

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

You likely can't join if

  • 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.

The study team makes the final eligibility decision.

Where it's taking place

  • Scottsdale, Arizona, United States
  • Bethesda, Maryland, United States
  • Columbus, Ohio, United States
  • Dallas, Texas, United States
  • Caba, Buenos Aires, Argentina
  • Innsbruck, Tyrol, Austria
  • Beijing, China
  • Copenhagen, Denmark
  • Lyon, France
  • Nantes, France
  • Paris, France
  • Villejuif, France
  • Mannheim, Baden-Wurttemberg, Germany
  • Berlin, Germany
  • Essen, Germany
  • Hamburg, Germany
  • Heidelberg, Germany
  • Debrecen, Hajdu Bihar Megye, Hungary
  • Budapest, Hungary
  • Kashiwa, Chiba, Japan

+ 7 more site(s).

Compensation & support

Compensation mentioned.

ClinicalTrials.gov doesn't provide a reliable structured field for payment or travel support - confirm details with the study team.

Questions & answers

Do participants get paid in this trial?

This study's listing includes signals that participants may be compensated or receive a stipend. Amounts vary and are set by the study team - confirm the details with them.

Is it free to join, and do I need insurance?

Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.

How long does this study last?

The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.

Who can join this trial?

This study is enrolling all sexes, 18 years to 100 years. The study team makes the final eligibility decision.

Where is this trial taking place?

Study sites include Scottsdale, Arizona, United States; Bethesda, Maryland, United States; Columbus, Ohio, United States; Dallas, Texas, United States; Caba, Buenos Aires, Argentina; Innsbruck, Tyrol, Austria and 21 more location(s). Enter your location above to see the nearest site and check your eligibility.

Explore other conditions

BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.