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Phase II open-label biomarker-driven study of darolutamide + goserelin + docetaxel in advanced salivary gland cancer
KCT0009586Phase 2
Key facts
- Status
- Recruiting
- Start
- Nov 2024
- Countries
- 1
- Sponsor
- Bayer
- Modality
- Classical Binding Small Molecules → Small Molecules, Covalent Small Molecules → Small Molecules, Nucleic Acid-Directed Small Molecules → Small Molecules
- Conditions
- salivary gland cancer (SGC)
01
Overview
Phase 2, open-label, single-arm trial of darolutamide, goserelin and docetaxel in salivary gland cancer (SGC), sponsored by Bayer. Primary endpoint: Progression-free survival. Started Nov 2024; status: recruiting.
02
Design
1 arm- Study design
- Non-randomizedOpen-labelSingle group
Darolutamide + goserelin + docetaxel
Single treatment arm receiving triple combination systemic therapy.
03
Who it enrols
Adults with histologically confirmed, measurable, androgen receptor-positive salivary gland cancer that is recurrent/progressive, locally advanced, or metastatic and not curable by surgery or radiotherapy. Patients must have RECIST v1.1 documented progression, ECOG 0-1, adequate organ function, and no prior exposure to most androgen receptor pathway inhibitors, goserelin, darolutamide, or CYP17 inhibitors.
04
Endpoints
Primary
Progression-free survival
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