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Dabrafenib + Trametinib Access for Cancer
Study Summary
This trial is to provide access for patients who have completed a Novartis or former GSK-sponsored study and are judged by the investigator as benefiting from continued treatment.
Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowTimeline
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Trial Design
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Who is running the clinical trial?
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- I had side effects from dabrafenib/trametinib that stopped my treatment.I am currently on dabrafenib/trametinib treatment in a Novartis or GSK study.My treatment is approved and covered by insurance in my country.
- Group 1: trametinib monotherapy
- Group 2: Combination therapy (dabrafenib & trametinib)
- Group 3: dabrafenib monotherapy
- No Placebo-Only Group - All patients enrolled in this study will receive some form of active treatment.
- Drug Has Already Been Approved - The FDA has already approved this drug, and is just seeking more data.
- Pivotal Trial - The final step before approval, pivotal trials feature drugs that have already shown basic safety & efficacy.
- Screening: It may take up to 3 Weeks to process to see if you qualify in this trial.
- Treatment: The duration you will receive the treatment varies.
- Follow Ups: You may be asked to continue sharing information regarding the trial for 6 Months after you stop receiving the treatment.
Frequently Asked Questions
Could I qualify to participate in this scientific experiment?
"A maximum of 100 people aged 18 to 65 who currently have melanoma, and are receiving treatment with the drugs dabrafenib/trametinib in a Novartis or former GSK sponsored study that has achieved its primary objective may be accepted into this clinical trial. Furthermore, it is necessary for patients to demonstrate potential benefit from continuing their current course of treatment."
Is enrollment for this research still available to eligible participants?
"Affirmative. Data provided on clinicaltrials.gov indicates that, as of October 21st 2022, the medical trial is actively recruiting prospective patients for enrollment - with a total requirement of 100 individuals across 3 locations since its initial posting on December 28th 2017."
Is the age limit for this experiment higher than 20 years old?
"This medical trial is recruiting individuals aged 18 and above but below 100 years of age."
How many participants is the research team recruiting for this clinical trial?
"Affirmative. Clinicaltrials.gov data confirms that this experiment, which went live on December 28th 2017, is actively enrolling volunteers. The protocol requires the recruitment of 100 patients from 3 different clinical locations."
Have there been any other investigations into the efficacy of trametinib?
"In 2012, the University of Chicago Medical Centre initiated a clinical trial to investigate trametinib. Since then, 86 studies have reached completion and 95 are currently active; with many being conducted in Bethesda, Maryland."
Are there any known risks associated with the use of trametinib?
"As this is a Phase 4 trial, meaning there are already approved treatments available on the market, our team at Power estimates trametinib's safety to be 3."
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