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Report for Clinical Trial NCT03360929

Developed by Shray Alag, 2020.
SNP Clinical Trial Gene

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

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.

NCT03360929 Non Small Cell Lung Cancer
MeSH:Lung Neoplasms Carcinoma, Non-Small-Cell Lung
HPO:Neoplasm of the lung Non-small cell lung carcinoma

1 Interventions

Name: AZD3759

Description: Strength: 50mg/tablet, 100mg/tablet Dosage and administration: Twice daily administration under fasting state.
Type: Drug
Group Labels: 1

experimental group


Primary Outcomes

Description: AE.SAE,vital signs, physical examination,laboratory examinations etc.

Measure: Incidence of Treatment-Emergent Adverse Events [Safety and Tolerability]

Time: 21 days after the first dose

Description: ORR, DCR, DOR, PFS and tumor size changing compared with baseline according to RECIST 1.1

Measure: anti-tumor activity

Time: every 6 weeks

Secondary Outcomes

Description: Peak Plasma Concentration (Cmax)

Measure: Peak Plasma Concentration (Cmax)

Time: 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.

Description: Area under the plasma concentration versus time curve (AUC)

Measure: Area under the plasma concentration versus time curve (AUC)

Time: 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.

Purpose: Treatment

Allocation: N/A

Single Group Assignment


There is one SNP

SNPs


1 L858R

3. Histologically or cytologically confirmed non-small cell lung cancer with activating mutation in EGFR gene (including Exon19Del and/or L858R). --- L858R ---



HPO Nodes


HPO: