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Genomically-Guided Treatment Trial in Brain Metastases
NCT03994796Phase 2
Key facts
- Status
- Active, not recruiting
- Start
- Oct 2019
- Primary completion
- Nov 2025
- Countries
- 1
- Sponsor
- Cancer and Leukemia Group B
- Modality
- Small Molecules
- Conditions
- brain metastasis (BM)
01
Overview
Phase 2, open-label trial of abemaciclib, paxalisib, entrectinib and adagrasib in brain metastasis (BM) (4 arms), sponsored by Cancer and Leukemia Group B. Primary endpoint: Objective Response Rate in the Brain at 5 years. Started Oct 2019; status: active, not recruiting.
02
Design
4 arms- Study design
- Non-randomizedOpen-label
Arm I (CDK gene mutation)
Abemaciclib PO BID on days 1-28.
Arm II (PI3K gene mutation)
Paxalisib PO QD on days 1-28.
Arm III (NTRK/ROS1 gene mutation)
Entrectinib PO QD on days 1-28.
Arm IV (KRAS G12C mutation)
Adagrasib PO BID on days 1-28.
03
Who it enrols
Patients with progressive parenchymal brain metastases from solid tumors harboring actionable mutations in NTRK, ROS1, KRAS G12C, CDK, or PI3K pathways. Must have measurable CNS disease, ECOG 0-2, adequate organ function, and have progressed on or failed prior standard therapies depending on primary tumor type.
04
Endpoints
Primary
Objective Response Rate in the Brain
Secondary
Systemic Response for Extracranial Disease
Clinical Benefit Rate for Central Nervous System
Clinical Benefit Rate for Extracranial Disease
Duration of Response for Brain Metastases
Duration of Response for Extracranial Disease
Progression-free Survival - Intracranial
Progression-free Survival - Extracranial
Site of First Progression
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