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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
Must not have
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.
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

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.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:
Select...
My treatment is approved and covered by insurance in my country.
Select...
I had side effects from dabrafenib/trametinib that stopped my treatment.

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

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
2018
Completed Phase 2
~260

Find a Location

Who is running the clinical trial?

Novartis PharmaceuticalsLead Sponsor
2,874 Previous Clinical Trials
4,199,891 Total Patients Enrolled
51 Trials studying Melanoma
30,775 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
~34 spots leftby Dec 2027
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