Öffentliches Studienregister des CCC-München

Studie BRF117277 GlaxoSmithKline

Studie Studiendesign Status Ein-/Auschlusskriterien Therapie Teilnehmer Dokumente Berechtigungen Tumorboards

Studie
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Studienakronym
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BRF117277 GlaxoSmithKline
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Vollständiger Titel
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A Phase II, Open-Label, Multicentre Study of Dabrafenib plus Trametinib in Subjects with BRAF Mutation-Positive Melanoma that has Metastasized to the Brain

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Beschreibung
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This is a multi-cohort, open label, Phase II study with dabrafenib (GSK2118436) and trametinib (GSK1120212) combination therapy in subjects with BRAF Mutation-Positive Melanoma that has metastasized to the Brain. This study will evaluate the safety and efficacy of 4 cohorts. Local therapy is referred to as therapy to the brain throughout
this protocol even if not identified as such.
 Cohort A: Seventy-five subjects with centrally confirmed BRAF V600E
cutaneous melanoma with metastases to the brain confirmed by MRI,
asymptomatic, without prior local (brain) therapy and ECOG score of 0-1.
 Cohort B: Fifteen subjects with locally confirmed BRAF V600E cutaneous
melanoma with metastases to the brain confirmed by MRI, asymptomatic, with
prior local (brain) therapy and ECOG score of 0-1.
 Cohort C: Up to fifteen subjects with locally confirmed BRAF V600 D/K/R
cutaneous melanoma with metastases to the brain confirmed by MRI,
asymptomatic, with or without prior local (brain) therapy and ECOG score of 0-
1.
 Cohort D: Fifteen subjects with locally confirmed BRAF V600 D/E/K/R
cutaneous melanoma with metastases to the brain confirmed by MRI,symptomatic, with or without prior local (brain) therapy and ECOG score of 0-2.
Subjects will receive dabrafenib capsules 150 mg twice daily and trametinib tablets 2 mg
once daily until evidence of disease progression, death, or unacceptable toxicity.
Subjects will be required to meet all eligibility criteria and return to clinic on a monthly basis for clinical and laboratory assessments. Intracranial and extracranial disease will be assessed at baseline, Week 4, Week 8, and every 8 weeks thereafter. After Week 40, disease assessments may be performed every 12 weeks. Response to treatment will be
evaluated using modified Response Evaluation Criteria in Solid Tumours (RECIST)version 1.1 [Eisenhauer, 2009].
Treatment will continue in all cohorts until disease progression, death, unacceptable
toxicity, or withdrawal of consent. After treatment discontinuation, subjects will be followed for skin assessments, survival and disease progression as applicable.

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EudraCT-Nr.
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Zuständige Einrichtung
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KUM - Klinik und Poliklinik für Dermatologie und Allergologie, München Lmu
Krankheitsentitäten
Klassifikation Code Beschreibung
ICD-10-GM C43.9 Bösartiges Melanom der Haut, nicht näher bezeichnet
Studiendesign
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Studientyp
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Interventionsstudie
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Verblindungstyp
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Offen
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Studienphase
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II
Status
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Status
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Rekrutierung beendet
Voten
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Ethikkommission - Votum
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Positiv
Initiierung & Abschluß
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Abschlussdatum (Plan / Ist)
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Unbekannt / Unbekannt
Teilnehmer
Funktion Vorname Nachname Einrichtung
World Verantwortlicher Ansprechpartner Carola Berking KUM - Klinik und Poliklinik für Dermatologie und Allergologie, München Magnifier
World Sponsor GSK Magnifier
World Hauptprüfer Carola Berking KUM - Klinik und Poliklinik für Dermatologie und Allergologie, München Magnifier