Evaluate Safety, Tolerability, Pharmacokinetics and Anti-tumor Activity of AZD3759
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|ClinicalTrials.gov Identifier: NCT03360929|
Recruitment Status : Active, not recruiting
First Posted : December 4, 2017
Last Update Posted : March 24, 2020
|Condition or disease||Intervention/treatment||Phase|
|Non Small Cell Lung Cancer||Drug: AZD3759||Phase 1 Phase 2|
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||15 participants|
|Intervention Model:||Single Group Assignment|
|Intervention Model Description:||This is a multi-center, open-label, dose escalation and phase II study, consisting of dose escalation study in Part A and phase II study in Part B.|
|Masking:||None (Open Label)|
|Official Title:||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|
|Actual Study Start Date :||October 30, 2017|
|Estimated Primary Completion Date :||November 30, 2020|
|Estimated Study Completion Date :||November 30, 2020|
Experimental: 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.
Strength: 50mg/tablet, 100mg/tablet Dosage and administration: Twice daily administration under fasting state.
- 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.
- anti-tumor activity [ Time Frame: every 6 weeks ]ORR, DCR, DOR, PFS and tumor size changing compared with baseline according to RECIST 1.1
- Peak Plasma Concentration (Cmax) [ Time Frame: 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) [ Time Frame: 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)
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03360929
|Guangdong General Hospital|
|Guangzhou, Guangdong, China, 510080|
|Wuhan, Hubei, China|
|Changsha, Hunan, China|
|Hangzhou, Zhejiang, China|
|Principal Investigator:||Yilong Wu, Professor||Guangdong Provincial People's Hospital|