Evaluate Safety, Tolerability, Pharmacokinetics and Anti-tumor Activity of AZD3759
|The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.|
|ClinicalTrials.gov Identifier: NCT03360929|
Recruitment Status : Recruiting
First Posted : December 4, 2017
Last Update Posted : May 29, 2019
|Condition or disease||Intervention/treatment||Phase|
|Non Small Cell Lung Cancer||Drug: AZD3759||Phase 1 Phase 2|
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||21 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 :||June 30, 2020|
|Estimated Study Completion Date :||June 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. Three dose cohorts are planned for dose escalation, including: 150, 250 and 300 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
|Contact: John Ge, M.D.||021 email@example.com|
|Contact: Yang Lu, M.D.||021 firstname.lastname@example.org|
|Guangdong General Hospital||Recruiting|
|Guangzhou, Guangdong, China, 510080|
|Contact: Qing Q Zhou 8620-83827812|
|Wuhan, Hubei, China|
|Changsha, Hunan, China|
|Hangzhou, Zhejiang, China|
|Principal Investigator:||Yilong Wu, Professor||Guangdong General Hospital|