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Protein Kinase Inhibitor

Dabrafenib + Trametinib Access for Cancer

Phase 4
Recruiting
Research Sponsored by Novartis Pharmaceuticals
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
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.
Be older than 18 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 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.
Awards & highlights
No Placebo-Only Group
Drug Has Already Been Approved
Pivotal Trial

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.

Who is the study for?
This trial is for patients already taking dabrafenib and/or trametinib in a Novartis or former GSK study, who have met the main goals of that study and are seen by their doctor as benefiting from ongoing treatment. It's not open to those who've had to stop these drugs due to side effects or if the drugs are available commercially with reimbursement in their country.Check my eligibility
What is being tested?
The trial provides continued access to dabrafenib and/or trametinib for patients with certain cancers like lung cancer, melanoma, solid tumors, rare cancers, or brain tumors. These medications were part of previous studies by Novartis/GSK where participants showed benefits.See study design
What are the potential side effects?
While specific side effects aren't listed here, any unresolved toxicities from prior use of dabrafenib/trametinib that led to treatment interruption would exclude someone from this trial. Typically such meds may cause skin reactions, fever, fatigue among other possible side effects.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
Select...
I am currently on dabrafenib/trametinib treatment in a Novartis or GSK study.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~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.
This trial's timeline: 3 weeks for screening, Varies for treatment, and 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. for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
Occurences of adverse events to evaluate long term safety and tolerability of dabrafenib, trametinib or combination
Secondary outcome measures
Clinical Benefit Assessment by investigator

Awards & Highlights

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.

Trial Design

3Treatment groups
Experimental Treatment
Group I: trametinib monotherapyExperimental Treatment1 Intervention
Patients in this study may receive: - monotherapy of trametinib
Group II: dabrafenib monotherapyExperimental Treatment1 Intervention
Patients in this study may receive: - monotherapy of dabrafenib
Group III: Combination therapy (dabrafenib & trametinib)Experimental Treatment2 Interventions
Patients in this study may receive: - the combination of dabrafenib and trametinib
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
dabrafenib
2016
Completed Phase 2
~60
trametinib
2012
Completed Phase 2
~200

Find a Location

Who is running the clinical trial?

Novartis PharmaceuticalsLead Sponsor
2,844 Previous Clinical Trials
4,193,392 Total Patients Enrolled
50 Trials studying Melanoma
30,758 Patients Enrolled for Melanoma

Media Library

Dabrafenib (Protein Kinase Inhibitor) Clinical Trial Eligibility Overview. Trial Name: NCT03340506 — Phase 4
Melanoma Research Study Groups: trametinib monotherapy, Combination therapy (dabrafenib & trametinib), dabrafenib monotherapy
Melanoma Clinical Trial 2023: Dabrafenib Highlights & Side Effects. Trial Name: NCT03340506 — Phase 4
Dabrafenib (Protein Kinase Inhibitor) 2023 Treatment Timeline for Medical Study. Trial Name: NCT03340506 — Phase 4

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

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."

Answered by AI

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."

Answered by AI

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."

Answered by AI

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."

Answered by AI

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."

Answered by AI

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."

Answered by AI
~38 spots leftby Dec 2027