Evaluate Safety, Tolerability, Pharmacokinetics and Anti-tumor Activity of AZD3759

Phase 1

Completed

• Conditions: Non Small Cell Lung Cancer
• Interventions: Drug: AZD3759

• Registration Number: NCT03360929
• Lead Sponsor: LYZZ Alpha Holding Ltd

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.

Study Timeline

• Study Start: 2017-10-30
• Study First Submitted: 2017-11-16
• Study First Submitted QC: 2017-11-28
• Study First Posted: 2017-12-04
• Primary Completion: 2020-11-13
• Study Completion: 2020-11-13
• Status Verified: 2022-11
• Last Update Submitted: 2022-11-22
• Last Update Posted: 2022-11-25

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 15

Inclusion Criteria

Not provided

Exclusion Criteria

Not provided

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
experimental group	AZD3759	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.

Primary Outcome Measures

Name	Time	Method
anti-tumor activity	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]	21 days after the first dose	AE.SAE,vital signs, physical examination,laboratory examinations etc.

Secondary Outcome Measures

Name	Time	Method
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.	Peak Plasma Concentration (Cmax)
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.	Area under the plasma concentration versus time curve (AUC)

Trial Locations

Locations (4)

0004; 🇨🇳 Wuhan, Hubei, China

Guangdong General Hospital; 🇨🇳 Guangzhou, Guangdong, China

0003; 🇨🇳 Hangzhou, Zhejiang, China

0002; 🇨🇳 Changsha, Hunan, China