A Phase I/II, Open-label, Multi-center Study to Evaluate Safety, Tolerability, Pharmacokinetics and Anti-tumor Activity of AZD3759 in Chinese Patients With EGFRm+ NSCLC With Central Nervous System (CNS) Metastases
Overview
- Phase
- Phase 1
- Intervention
- AZD3759
- Conditions
- Non Small Cell Lung Cancer
- Sponsor
- LYZZ Alpha Holding Ltd
- Enrollment
- 15
- Locations
- 4
- Primary Endpoint
- anti-tumor activity
- Status
- Completed
- Last Updated
- 3 years ago
Overview
Brief Summary
This is a multi-center, open-label, dose escalation and phase I/II study, consisting of dose escalation in Part A and phase II study in Part B.
Detailed Description
Dose escalation and dose expansion to determine safety and tolerability of AZD3759, and explore RP2D in treatment of Chinese patients with EGFRm+ NSCLC with CNS metastasis. Two dose cohorts include: 150 and 250mg twice daily. Subjects will receive multiple doses of AZD3759 for consecutively 21 days each cycle. Dose escalation is planned to be performed in a single center, and dose expansion in multiple centers.
Investigators
Eligibility Criteria
Inclusion Criteria
- Not provided
Exclusion Criteria
- Not provided
Arms & Interventions
experimental group
Study drug: AZD3759 Strength: 50mg/tablet, 100mg/tablet Dose escalation:A treatment cycle consists of consecutive 21 days of dosing. two dose cohorts are planned for dose escalation, including: 150 and 250 mg twice daily. RP2D in dose expansion.
Intervention: AZD3759
Outcomes
Primary Outcomes
anti-tumor activity
Time Frame: every 6 weeks
ORR, DCR, DOR, PFS and tumor size changing compared with baseline according to RECIST 1.1
Incidence of Treatment-Emergent Adverse Events [Safety and Tolerability]
Time Frame: 21 days after the first dose
AE.SAE,vital signs, physical examination,laboratory examinations etc.
Secondary Outcomes
- Peak Plasma Concentration (Cmax)(Pre-dose and 0.5h, 1h, 1.5h, 2h, 3h, 4h, 6h, 8h, 10h, 12h, 24h(C0D2) and 48h(C0D3) after the first single-dose(C0D1) ;Pre-dose of C1D1,C1D8, C1D15, C1D21 and C2D1 and 0.5h, 1h, 1.5h, 2h, 3h, 4h, 6h, 8h, 10h, 12h post dose on C1D21 during multiple dosing.)
- Area under the plasma concentration versus time curve (AUC)(Pre-dose and 0.5h, 1h, 1.5h, 2h, 3h, 4h, 6h, 8h, 10h, 12h, 24h(C0D2) and 48h(C0D3) after the first single-dose(C0D1) ;Pre-dose of C1D1,C1D8, C1D15, C1D21 and C2D1 and 0.5h, 1h, 1.5h, 2h, 3h, 4h, 6h, 8h, 10h, 12h post dose on C1D21 during multiple dosing.)