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

Drug Has Already Been Approved

Pivotal Trial

No Placebo-Only Group

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.

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.

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

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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:

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My treatment is approved and covered by insurance in my country.

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I had side effects from dabrafenib/trametinib that stopped my treatment.

Timeline

Screening ~ 3 weeks3 visits

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.

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.