Study identifier:D5160C00018
ClinicalTrials.gov identifier:NCT02529995
EudraCT identifier:N/A
CTIS identifier:N/A
Phase I, Open-Label, Two Parts Study in Chinese Patients with Advanced NSCLC who have Progressed Following Prior Therapy with an EGFR Tyrosine Kinase Inhibitor Agent
Carcinoma, Non-Small-Cell Lung with EGFR mutation positive
Phase 1
No
AZD9291 40 mg, AZD9291 80 mg
All
31
Interventional
18 Years - 130 Years
Allocation: Non-randomized
Endpoint Classification: Pharmacokinetics
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Other
Verified 01 Feb 2020 by AstraZeneca
AstraZeneca
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A Phase I, Open-Label, Two Parts Study to Assess the Safety, Tolerability,Pharmacokinetics and Preliminary Anti-tumour Activity of AZD9291 in Chinese Patients with Advanced Non-Small Cell Lung Cancer who have Progressed Following Prior Therapy with an Epidermal Growth Factor Receptor Tyrosine Kinase Inhibitor Agent Study Objective: 1, Primary Objective To characterise the pharmacokinetics (PK) of AZD9291 and its metabolites (AZ5104 and AZ7550) after single then multiple doses of AZD9291 administered orally once daily in Chinese patients with locally advanced or metastatic non small cell lung Cancer (NSCLC) who have progressed following prior therapy with an approved Epidermal Growth Factor Receptor Tyrosine Kinase Inhibitor (EGFR TKI) agent. 2, Secondary objective(s) To investigate the safety and tolerability of AZD9291 when given orally to Chinese patients with locally advanced or metastatic NSCLC who have progressed following prior therapy with an approved EGFR TKI agent. To obtain a preliminary assessment of the anti-tumour activity of AZD9291 by evaluation of tumour response using Response Evaluation Criteria in Solid Tumours (RECIST) version 1.1.
This is a phase I, open-label, two parts (Part A and Part B) study to determine the pharmacokinetics of AZD9291 administered orally at two dose levels (40 mg and 80 mg) in patients with locally advanced or metastatic NSCLC who have progressed following prior therapy with an approved EGFR TKI agent (+/- additional chemotherapy regimens). Approximately 24 patients will enter into this study, with 12 patients at each dose level. - Cohort 1 will investigate the pharmacokinetics of single then multiple dosing of AZD9291 at 40 mg once daily dose. - Cohort 2 will investigate the pharmacokinetics of single then multiple dosing of AZD9291 at 80 mg once daily dose. The enrollment of Cohort 2 will start after Cohort 1 finishes the enrollment. The first 12 patients enrolled in the study will be in 40 mg dose Cohort. Patients will be administered a single dose of AZD9291 on Day 1, Cycle 0 at the beginning of Part A period. From Day 2 to Day 6, no treatment will be given, but PK samples will be obtained; on Day 7 (Cycle1, Day1), the patients will be administered AZD9291 once daily on a continuous schedule, ie, no break in AZD9291 dosing. Part A will complete after Cycle 4 treatment and Part B will start without treatment interruption. Patients in both cohorts should continue on treatment with AZD9291 until a treatment discontinuation criterion is met. There is no maximum duration of treatment as patients may continue to receive AZD9291 beyond RECIST 1.1 defined progression as long as they are continuing to receive clinical benefit, as judged by the investigator. The whole study will be divided nominally into two parts: Part A will assess the pharmacokinetics and preliminary efficacy and safety of AZD9291 at 40 mg and 80 mg respectively, and Part B will assess only the safety and efficacy data of AZD9291. Following completion of the Part A, patients will automatically continue to Part B.
Location
Location
Guangzhou, China, 510060
Location
Shanghai, China, 200032
Arms | Assigned Interventions |
---|---|
Experimental: AZD9291 40 mg Cohort 1: 40 mg once daily | Drug: AZD9291 40 mg This is a two parts (Part A and Part B) study to determine the pharmacokinetics of AZD9291 administered orally at two dose levels (40 mg Cohort 1 and 80 mg Cohort 2) in patients with locally advanced or metastatic NSCLC who have progressed following prior therapy with an EGFR TKI agent (+/- additional chemotherapy regimens). Other Name: No |
Experimental: AZD9291 80 mg Cohort 2: 80 mg once daily | Drug: AZD9291 80 mg This is a two parts (Part A and Part B) study to determine the pharmacokinetics of AZD9291 administered orally at two dose levels (40 mg Cohort 1 and 80 mg Cohort 2) in patients with locally advanced or metastatic NSCLC who have progressed following prior therapy with an EGFR TKI agent (+/- additional chemotherapy regimens). Other Name: No |
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