Study to allow access to dabrafenib and/or trametinib for subjects that are benefiting from dabrafenib and/or trametinib treatment in a Novartis or GSK sponsored study.
- Conditions
- Multiple indicationsMedDRA version: 20.0Level: SOCClassification code: 10029104Term: Neoplasms benign malignant and unspecified (incl cysts and polyps) Class: 2MedDRA version: 27.0Level: LLTClassification code: 10027481Term: Metastatic melanoma Class: 10029104MedDRA version: 21.1Level: PTClassification code: 10061873Term: Non-small cell lung cancer Class: 100000004864Therapeutic area: Diseases [C] - Neoplasms [C04]
- Registration Number
- CTIS2023-509318-13-00
- Lead Sponsor
- ovartis Pharma AG
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Recruiting
- Sex
- All
- Target Recruitment
- 36
Subject is currently receiving treatment with dabrafenib and/or trametinib monotherapy or combination within a Novartis or former GSK sponsored study which has fulfilled the requirements for the primary objective., In the opinion of the Investigator would benefit from continued treatment., Subject has demonstrated compliance, as assessed by the Investigator, within the parent study protocol requirement(s)., Willingness and ability to comply with scheduled visits, treatment plans and any other study procedures., Written informed consent obtained prior to enrolling in the roll-over study and receiving study medication. If consent cannot be expressed in writing, it must be formally documented and witnessed, ideally via an independent trusted witness., Does not require treatment with prohibited concomitant medications.
Subject has been previously permanently discontinued from study treatment in the parent protocol., Subject’s indication is commercially available and reimbursed in the local country., Subject currently has unresolved toxicities for which dabrafenib and/or trametinib dosing has been interrupted in the parent study., Female subjects who are lactating, unless they are willing discontinue nursing prior to first dose of study treatment, and willing to refrain from nursing throughout the treatment period and for 4 months following the last dose of study treatment., Women of childbearing potential, defined as all women physiologically capable of becoming pregnant, unless they are using highly effective methods of contraception whilst taking study treatment and for 16 weeks after stopping treatment with trametinib (for trametinib monotherapy trials); 2 weeks after stopping treatment with dabrafenib (for dabrafenib monotherapy trials); 16 weeks after stopping treatment with trametinib or 2 weeks after stopping treatment with dabrafenib, whichever is longer (for trials of dabrafenib in combination with trametinib)., Sexually active males unwilling to use a condom during intercourse whilst taking study treatment and for: 16 weeks after stopping study treatment with dabrafenib in combination with trametinib 2 weeks after stopping study treatment with dabrafenib monotherapy 16 weeks after stopping study treatment with trametinib monotherapy A condom is required for all sexually active male participants to prevent them from fathering a child AND to prevent delivery of study treatment via seminal fluid to their partner. In addition, male participants must not donate sperm for the time period specified above.
Study & Design
- Study Type
- Interventional clinical trial of medicinal product
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Main Objective: The primary objective is to evaluate long-term safety as assessed by occurrence of AEs/SAEs.;Secondary Objective: To evaluate clinical benefit as assessed by the Investigator.;Primary end point(s): Frequency and severity of AEs/SAEs.
- Secondary Outcome Measures
Name Time Method Secondary end point(s):Proportion of subjects with clinical benefit as assessed by the Investigator at scheduled visits.