Clinical trial • Phase IV • Oncology
TRAMETINIB for Metastatic melanoma | Non-small cell lung cancer
Phase IV trial of TRAMETINIB for Metastatic melanoma | Non-small cell lung cancer. open-label, none/not specified-controlled. 82 participants.
Overview
- Trial Therapeutic Area
- Oncology
- Trial Disease
- Metastatic melanoma | Non-small cell lung cancer
- Trial Stage
- Phase IV
- Drug Modality
- Small molecule
- Paediatric Trial
- Yes
- Orphan Drug
- Yes
Key dates
- Initial CTIS Submission Date
- 10-07-2024
- First CTIS Authorization Date
- 01-08-2024
Trial design
open-label, none/not specified-controlled Phase IV trial across 19 sites in Austria, France, Netherlands and others.
- Open Label
- Yes
- Comparator
- None/Not specified
- Target Sample Size
- 82
Eligibility
Recruits 82 paediatric patients.
- Pregnancy Exclusion
- 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).
- Vulnerable Population
- Vulnerable populations selected (isVulnerablePopulationSelected = true). Informed consent: written informed consent is required prior to enrolment and prior to receiving study medication; if consent cannot be expressed in writing it must be formally documented and witnessed (ideally via an independent trusted witness). Country-specific informed consent materials include Parent/Legal Guardian forms and Adolescent Assent documents (e.g. Spanish submissions include 'Parent Legal Guardian' and 'Adolescent Assent' documents), indicating procedures for assent and guardian consent for minors.
Inclusion criteria
- {"criterion_text":"- 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.\n- In the opinion of the Investigator would benefit from continued treatment.\n- Subject has demonstrated compliance, as assessed by the Investigator, within the parent study protocol requirement(s).\n- Willingness and ability to comply with scheduled visits, treatment plans and any other study procedures.\n- 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.\n- Does not require treatment with prohibited concomitant medications."}
Exclusion criteria
- {"criterion_text":"- Subject has been previously permanently discontinued from study treatment in the parent protocol.\n- Subject’s indication is commercially available and reimbursed in the local country.\n- Subject currently has unresolved toxicities for which dabrafenib and/or trametinib dosing has been interrupted in the parent study. If the patient, in the opinion of the investigator and as per parent protocol, can resume treatment then the patient will be allowed to enroll in CDRB436X2X02B study.\n- 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.\n- 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).\n- 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."}
Endpoints
Primary endpoints
- {"endpoint_text":"- Frequency and severity of AEs/SAEs.","definition_or_measurement_approach":"As stated in the main objective: evaluate long-term safety as assessed by occurrence of AEs/SAEs."}
Secondary endpoints
- {"endpoint_text":"- Proportion of subjects with clinical benefit as assessed by the Investigator at scheduled visits.","definition_or_measurement_approach":"Clinical benefit assessed by the Investigator at scheduled visits as described in the secondary objectives."}
Recruitment
- Planned Sample Size
- 82
- Recruitment Window Months
- 155
- Consent Approach
- 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. Adolescent assent and Parent/Legal Guardian consent procedures are provided (country-specific ICFs include Adolescent Assent and Parent Legal Guardian forms). ICFs available in multiple country/languages (examples in dossier: German, French, Dutch, Spanish, Hungarian, Danish, English).
Geography
- Total Number Of Sites
- 19
- Total Number Of Participants
- 19
Austria
- Earliest CTIS Part Ii Submission Date
- 24-07-2024
- Latest Decision Or Authorization Date
- 17-02-2025
- Processing Time Days
- 208
- Number Of Sites
- 1
- Number Of Participants
- 1
Sites
- Site Name
- Medizinische Universitaet Innsbruck
- Department Name
- #3050:Haematology Oncology
- Principal Investigator Name
- Wolfgang Willenbacher
- Principal Investigator Email
- wolfgang.willenbacher@tirol-kliniken.at
- Contact Person Name
- Wolfgang Willenbacher
- Contact Person Email
- wolfgang.willenbacher@tirol-kliniken.at
France
- Earliest CTIS Part Ii Submission Date
- 24-07-2024
- Latest Decision Or Authorization Date
- 30-01-2025
- Processing Time Days
- 190
- Number Of Sites
- 4
- Number Of Participants
- 4
Sites
- Site Name
- Hopital Tenon
- Department Name
- #1701:Service de Pneumologie
- Principal Investigator Name
- Jacques CADRANEL
- Principal Investigator Email
- jacques.cadranel@aphp.fr
- Contact Person Name
- Jacques CADRANEL
- Contact Person Email
- jacques.cadranel@aphp.fr
- Site Name
- Centre Leon Berard
- Department Name
- #1703:Service Oncologie Médicale
- Principal Investigator Name
- Jean-Yves BLAY
- Principal Investigator Email
- jean-yves.blay@lyon.unicancer.fr
- Contact Person Name
- Jean-Yves BLAY
- Contact Person Email
- jean-yves.blay@lyon.unicancer.fr
- Site Name
- Centre Hospitalier Universitaire De Nantes
- Department Name
- #1704:Hématologie Clinique
- Principal Investigator Name
- Philippe MOREAU
- Principal Investigator Email
- philippe.moreau@chu-nantes.fr
- Contact Person Name
- Philippe MOREAU
- Contact Person Email
- philippe.moreau@chu-nantes.fr
- Site Name
- Institut Gustave Roussy
- Department Name
- #1702:Département d’Innovation Thérapeutique et des Essais Précoces
- Principal Investigator Name
- Anas GAZZAH
- Principal Investigator Email
- anas.gazzah@gustaveroussy.fr
- Contact Person Name
- Anas GAZZAH
- Contact Person Email
- anas.gazzah@gustaveroussy.fr
Netherlands
- Earliest CTIS Part Ii Submission Date
- 24-07-2024
- Latest Decision Or Authorization Date
- 03-02-2025
- Processing Time Days
- 194
- Number Of Sites
- 1
- Number Of Participants
- 1
Sites
- Site Name
- Universitair Medisch Centrum Utrecht
- Department Name
- #6050:Hematology
- Principal Investigator Name
- Anke Janssen
- Principal Investigator Email
- a.janssen-7@umcutrecht.nl
- Contact Person Name
- Anke Janssen
- Contact Person Email
- a.janssen-7@umcutrecht.nl
Germany
- Earliest CTIS Part Ii Submission Date
- 24-07-2024
- Latest Decision Or Authorization Date
- 03-02-2025
- Processing Time Days
- 194
- Number Of Sites
- 3
- Number Of Participants
- 3
Sites
- Site Name
- Universitaetsklinikum Heidelberg AöR
- Department Name
- 2054: Medizinische Klinik V
- Principal Investigator Name
- Isabelle Kraemer
- Principal Investigator Email
- Isabelle.kraemer@med.uni-heidelberg.de
- Contact Person Name
- Isabelle Kraemer
- Contact Person Email
- Isabelle.kraemer@med.uni-heidelberg.de
- Site Name
- University Medical Center Hamburg-Eppendorf
- Department Name
- 2053: Zentrum für Onkologie
- Principal Investigator Name
- Marianne Sinn
- Principal Investigator Email
- Ma.sinn@uke.d
- Contact Person Name
- Marianne Sinn
- Contact Person Email
- Ma.sinn@uke.d
- Site Name
- Universitaetsklinikum Mannheim GmbH
- Department Name
- 2051: Hämatologie und Internistische Onkologie
- Principal Investigator Name
- Ralf-Dieter Hofheinz
- Principal Investigator Email
- Ralf.hofheint@umm.de
- Contact Person Name
- Ralf-Dieter Hofheinz
- Contact Person Email
- Ralf.hofheint@umm.de
Hungary
- Earliest CTIS Part Ii Submission Date
- 24-07-2024
- Latest Decision Or Authorization Date
- 12-02-2025
- Processing Time Days
- 203
- Number Of Sites
- 2
- Number Of Participants
- 2
Sites
- Site Name
- University Of Debrecen
- Department Name
- #9502
- Principal Investigator Name
- Remenyik Eva
- Principal Investigator Email
- remenyik@med.unideb.hu
- Contact Person Name
- Remenyik Eva
- Contact Person Email
- remenyik@med.unideb.hu
- Site Name
- Orszagos Onkologiai Intezet
- Department Name
- #9503
- Principal Investigator Name
- Liszkay Gabriella
- Principal Investigator Email
- liszkay@oncol.hu
- Contact Person Name
- Liszkay Gabriella
- Contact Person Email
- liszkay@oncol.hu
Spain
- Earliest CTIS Part Ii Submission Date
- 24-07-2024
- Latest Decision Or Authorization Date
- 13-05-2026
- Processing Time Days
- 658
- Number Of Sites
- 7
- Number Of Participants
- 7
Sites
- Site Name
- Hospital Universitario Fundacion Jimenez Diaz
- Department Name
- #3101:Oncología médica
- Principal Investigator Name
- Victor Moreno Garcia
- Principal Investigator Email
- victor.moreno@startmadrid.com
- Contact Person Name
- Victor Moreno Garcia
- Contact Person Email
- victor.moreno@startmadrid.com
- Site Name
- Hospital Universitario Y Politecnico La Fe
- Department Name
- #3106:Onco Hematología
- Principal Investigator Name
- Adela Cañete Nieto
- Principal Investigator Email
- canyete_ade@gva.es
- Contact Person Name
- Adela Cañete Nieto
- Contact Person Email
- canyete_ade@gva.es
- Site Name
- Hospital Universitario Hm Sanchinarro
- Department Name
- #3102:Oncología médica
- Principal Investigator Name
- Juan José Soto Castillo
- Principal Investigator Email
- JuanJ.Soto@startmadrid.com
- Contact Person Name
- Juan José Soto Castillo
- Contact Person Email
- JuanJ.Soto@startmadrid.com
- Site Name
- Hospital Universitari Vall D Hebron
- Department Name
- #3100:Oncología médica
- Principal Investigator Name
- Eva Muñoz Couselo
- Principal Investigator Email
- emunoz@vhebron.net
- Contact Person Name
- Eva Muñoz Couselo
- Contact Person Email
- emunoz@vhebron.net
- Site Name
- Hospital General Universitario Gregorio Maranon
- Department Name
- #3105:Onco Hematología
- Principal Investigator Name
- David Diaz Perez
- Principal Investigator Email
- ddiazp@salud.madrid.org
- Contact Person Name
- David Diaz Perez
- Contact Person Email
- ddiazp@salud.madrid.org
- Site Name
- Hospital Infantil Universitario Nino Jesus
- Department Name
- #3104:Onco Hematología
- Principal Investigator Name
- Beatriz Vergara Muñoz
- Principal Investigator Email
- beatriz.vergara@salud.madrid.org
- Contact Person Name
- Beatriz Vergara Muñoz
- Contact Person Email
- beatriz.vergara@salud.madrid.org
Denmark
- Earliest CTIS Part Ii Submission Date
- 24-07-2024
- Latest Decision Or Authorization Date
- 13-05-2026
- Processing Time Days
- 658
- Number Of Sites
- 1
- Number Of Participants
- 1
Sites
- Site Name
- Rigshospitalet
- Department Name
- #2050:Hæmatologisk afdeling
- Principal Investigator Name
- Jindrich Mourek
- Principal Investigator Email
- Jindrich.Mourek@regionh.dk
- Contact Person Name
- Jindrich Mourek
- Contact Person Email
- Jindrich.Mourek@regionh.dk
Sponsor
Primary sponsor
- Full Name
- Novartis Pharma AG
- Organisation Type
- Pharmaceutical company
- Country Of Registered Address
- Switzerland
Contract research organisations
- Name
- Parexel International (IRL) Limited
- Responsibilities
- sponsorDuties codes: [12]; contact email: Clinicaltrial.Enquiries@parexel.com
- Name
- PAREXEL International GmbH
- Responsibilities
- sponsorDuties codes: [14]; contact email: Patrice.volensky@parexel.com
- Name
- Icon Clinical Research Limited
- Responsibilities
- sponsorDuties codes: [1]; contact email: Triona.PriceSmith1@docsglobal.com
- Name
- IQVIA Limited
- Responsibilities
- sponsorDuties codes: [1]; contact email: eu_clinical_trials_information@iqvia.com
- Name
- Syneos Health Inc.
- Responsibilities
- sponsorDuties codes: [1]; contact email: sm_ctis@syneoshealth.com
Third parties
- {"country":"Austria","full_name":"Mag. Andreas Raffeiner GmbH","duties_or_roles":"sponsorDuties codes: [8]; contact email: andreas.raffeiner@studien-monitor.at","organisation_type":"Pharmaceutical company"}
- {"country":"Ireland","full_name":"Parexel International (IRL) Limited","duties_or_roles":"sponsorDuties codes: [12]; contact email: Clinicaltrial.Enquiries@parexel.com","organisation_type":"Pharmaceutical company"}
- {"country":"Denmark","full_name":"Specific Pharma A/S","duties_or_roles":"sponsorDuties codes: [15]; value: 'Pass-through warehouse (drug distribution, drug return and destruction)'; contact email: ctsm@specificpharma.com","organisation_type":"Pharmaceutical company"}
- {"country":"Austria","full_name":"Abf Pharmaceutical Services GmbH","duties_or_roles":"sponsorDuties codes: [15]; value: 'Local depot for storage and distribution of AxMP to sites/ final Rec. + Destructionof used/unused IMP and AxMP, at EoT'; contact email: Heidi.Buchinger@abf-pharma.com","organisation_type":"Pharmaceutical company"}
- {"country":"Ireland","full_name":"Icon Clinical Research Limited","duties_or_roles":"sponsorDuties codes: [1]; contact email: Triona.PriceSmith1@docsglobal.com","organisation_type":"Pharmaceutical company"}
- {"country":"United Kingdom","full_name":"IQVIA Limited","duties_or_roles":"sponsorDuties codes: [1]; contact email: eu_clinical_trials_information@iqvia.com","organisation_type":"Pharmaceutical company"}
- {"country":"Germany","full_name":"PAREXEL International GmbH","duties_or_roles":"sponsorDuties codes: [14]; contact email: Patrice.volensky@parexel.com","organisation_type":"Pharmaceutical company"}
- {"country":"United States","full_name":"Syneos Health Inc.","duties_or_roles":"sponsorDuties codes: [1]; contact email: sm_ctis@syneoshealth.com","organisation_type":"Pharmaceutical company"}
Investigational products
- Investigational Product Name
- Mekinist 0.5 mg film-coated tablets
- Active Substance
- TRAMETINIB
- Modality
- Small molecule
- Routes Of Administration
- ORAL USE
- Route
- ORAL USE
- Authorisation Status
- Authorised (marketing authorisation present, prodAuthStatus=2)
- Orphan Designation
- Yes
- Maximum Dose
- 2 mg (maxDailyDoseAmount: 2 mg)
- Investigational Product Name
- Mekinist 2 mg film-coated tablets
- Active Substance
- TRAMETINIB
- Modality
- Small molecule
- Routes Of Administration
- ORAL USE
- Route
- ORAL USE
- Authorisation Status
- Authorised (marketing authorisation present, prodAuthStatus=2)
- Orphan Designation
- Yes
- Maximum Dose
- 2 mg (maxDailyDoseAmount: 2 mg)
- Investigational Product Name
- TMT212 (powder for oral solution) - paediatric formulation
- Active Substance
- TRAMETINIB
- Modality
- Small molecule
- Routes Of Administration
- ORAL USE
- Route
- ORAL USE
- Authorisation Status
- Not authorised / Investigational (prodAuthStatus=1) for this product entry
- Orphan Designation
- Yes
- Maximum Dose
- 2 mg (maxDailyDoseAmount: 2 mg)
- Investigational Product Name
- DRB436 (capsule, hard)
- Active Substance
- DABRAFENIB MESYLATE
- Modality
- Small molecule
- Routes Of Administration
- ORAL USE
- Route
- ORAL USE
- Authorisation Status
- Not authorised / Investigational (prodAuthStatus=1) for this product entry
- Orphan Designation
- Yes
- Maximum Dose
- 300 mg (maxDailyDoseAmount: 300 mg)
- Investigational Product Name
- DRB436 (dispersible tablet) - paediatric formulation
- Active Substance
- DABRAFENIB MESYLATE
- Modality
- Small molecule
- Routes Of Administration
- ORAL USE
- Route
- ORAL USE
- Authorisation Status
- Not authorised / Investigational (prodAuthStatus=1) for this product entry
- Orphan Designation
- Yes
- Maximum Dose
- 300 mg (maxDailyDoseAmount: 300 mg)
- Combination Treatment
- Yes
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