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Trial intelligence / Profile preview
Bimiralisib in HNSCC with NOTCH1 LOF Mutations
NCT03740100Phase 2
Key facts
- Status
- Terminated
- Start
- Jan 2019
- Primary completion
- Aug 2020
- Countries
- 1
- Sponsor
- University of Texas MD Anderson Cancer Center
- Modality
- Small Molecules
- Drugs
- bimiralisib
- Conditions
- head and neck squamous cell carcinoma (HNSCC)
01
Overview
Phase 2, open-label, single-arm trial of bimiralisib in head and neck squamous cell carcinoma (HNSCC), sponsored by University of Texas MD Anderson Cancer Center. Primary endpoint: Objective Response Rate at 12 weeks. Started Jan 2019; status: terminated.
02
Design
1 arm- Study design
- Non-randomizedOpen-labelSingle group
Open single arm
Bimiralisib capsules orally
03
Who it enrols
Patients with histologically confirmed HNSCC harboring NOTCH1 LOF mutations for whom no standard curative therapy is available.
04
Endpoints
Primary
Objective Response Rate
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