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Also known as AZD9291 tablet dosing
AZD9291 dosing · 6 trials · 3 indications
To evaluate concordance of T790M plasma mutation testing between the Cobas test and each of other platforms: Super-ARMS, digital PCR or NGS.
To assess the efficacy of AZD9291 monotherapy by assessment of PFS in adult patients with advanced or metastatic NSCLC, who have received prior EGFR- TKI therapy and are T790M mutation positive detected by any one of the four plasma testing platforms. PFS was defined using Response Evaluation Criteria In Solid Tumors version 1.1(RECIST v1.1).
OS was defined as the time, in months from the date of first dose of Osimertinib until death due to any cause, or at last documented contact with participant status "alive" (in this study any participants alive at study discontinuation, or lost to follow-up was considered being censored at study discontinuation date or at the last known date participant was alive). OS was summarized using a Kaplan-Meier (KM) estimate of the median time to death or censoring together with their 95% confidence intervals.
Safety assessment of Osimertinib was analyzed by evaluating AEs and SAEs.
Rate and extent of absorption of rosuvastatin by assessment of Cmax. Single rosuvastatin doses were first without, then with AZD9291 (Day 1 \[Period 1\] and Day 32 \[Period 3\], respectively).
Rate and extent of absorption of rosuvastatin by assessment of AUC from time zero extrapolated to infinity. Single rosuvastatin doses were first without, then with AZD9291 (Day 1; Period 1 and Day 32; Period 3, respectively).
Rate and extent of absorption of AZD9291 following single oral doses of AZD9291 tablet formulation by assessment of maximum plasma AZD9291 concentration (Cmax).
Rate and extent of absorption of AZD9291 following single oral doses of AZD9291 tablet formulation by assessment of area under the plasma concentration time curve from zero to infinity (AUC).
Pharmacokinetics of simvastatin by assessment of maximum plasma simvastatin concentration
Pharmacokinetics of simvastatin by assessment of area under the plasma concentration time curve from zero to infinity
Rate and extent of absorption of AZD9291 by assessment of maximum plasma concentration at steady state (Css,max). AZD9291 doses were first without, then with rifampicin (Periods 1 and 2, respectively).
Rate and extent of absorption of AZD9291 by assessment of AUCtau. AZD9291 doses were first without, then with rifampicin (Periods 1 and 2, respectively).
| Arm | Type | Description |
|---|---|---|
| AZD9291 | EXPERIMENTAL | Single arm of AZD9291, starting dose of 80mg |
| AZD9291 and rosuvastatin | EXPERIMENTAL | Sequential treatments of rosuvastatin alone followed by AZD9291 alone, followed by rosuvastatin + AZD9291. |
| Normal hepatic function | OTHER | Patients without a history or presence of hepatic disease |
| Mild hepatic impairment | OTHER | Patients defined by the Child-Pugh classification system to be Child-Pugh A |
| Moderate hepatic impairment | OTHER | Patients defined by the Child-Pugh classification system to be Child-Pugh B |
| AZD9291 and simvastatin | EXPERIMENTAL | Sequential treatments of simvastatin alone followed by AZD9291 alone, followed by simvastatin + AZD9291. |
| Rifampicin and AZD9291 | EXPERIMENTAL | Sequential treatments of AZD9291 alone followed by AZD9291 +rifampicin, followed by AZD9291 alone. |
| Name | Type | Description |
|---|---|---|
| T790M+ Testing | PROCEDURE | The patient will need to have T790M+ testing |
| Baseline Visit Blood & Urine Testing | PROCEDURE | Blood count and standard chemistry testing to ensure patient meets inclusion/exclusion criteria |
| Baseline ECG | PROCEDURE | ECG to ensure absence of any cardiac abnormality |
| Visual Slit-Lamp Testing | PROCEDURE | Slit-lamp testing performed to ensure patients do not have any eye abnormalities or symptoms |
| AZD9291 Dosing | DRUG | Patients to be provided with AZD9291 every 6 weeks (+/- 7 days) |
| Plasma AZD9291 testing | PROCEDURE | The patient will need to have plasma AZD9291 testing before treatment |
| Pharmacokinetic sampling - AZD9291 | PROCEDURE | Blood sampling to measure AZD9291 |
| AZD9291 tablet dosing | DRUG | Part A: AZD9291 80mg tablet taken from Days 4 to 35. Part B: AZD9291 80mg tablet taken daily for 12 months. |
| Rosuvastatin | DRUG | Rosuvastatin (BCRP substrate) 20mg taken once daily on Days 1 and 32 (Part A) . |
| Pharmacokinetic sampling - rosuvastatin | PROCEDURE | Blood sampling to measure rosuvastatin levels |
| Pharmacokinetic sampling - AZ5140 and AZ7550 | PROCEDURE | Blood samples to measure levels of AZ5140 and AZ7550 |
| Simvastatin | DRUG | Simvastatin (CYP substrate) 40mg taken once daily on Days 1 and 31 (Part A) |
| Pharmacokinetic sampling - simvastatin | PROCEDURE | Blood sampling to measure simvastatin levels |
| Rifampicin | DRUG | Rifampicin (CYP inducer) 600mg taken once daily from Day 29 to Day 49 (Part A) |
| Pharmacokinetic sampling - rifampicin | PROCEDURE | Blood sampling to measure rifampicin levels |
Inclusion Criteria: 1. Provision of informed consent prior to any study specific procedures. 2. Adults (according to China regulations for age of majority) 3. Histological or cytological confirmed locally advanced NSCLC (stage IIIB) or metastatic (stage IV) NSCLC, not amenable to curative surgery o...
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AZD9291 is an investigational small molecule developed for oncology indications including lung cancer, non small cell lung cancer, and solid tumours. Its clinical program has focused on patients with EGFR mutation positive disease, including the EGFR T790M mutation, and it has been studied in Phase 3 and Phase 1 trials.
AZD9291 is being developed by AstraZeneca PLC, which trades under the ticker AZN. The company has sponsored the clinical trial program for the drug across multiple countries including the United States, United Kingdom, China, and others.
AZD9291 is in Phase 3 clinical development. The program includes completed Phase 3 trials such as NCT02997501 and NCT02474355, as well as completed Phase 1 trials including NCT02317016 and NCT02197247. It is an investigational agent and has not been approved by the FDA.
AZD9291 has been studied in completed trials including NCT02997501, a Phase 3 T790M plasma testing methodology comparison in China; NCT02474355, a Phase 3 real world treatment study in advanced or metastatic EGFR T790M mutation NSCLC across 16 countries; and Phase 1 trials NCT02317016 and NCT02197247.
AZD9291 tablet dosing is an alternative name for AZD9291. Both refer to the same investigational small molecule developed by AstraZeneca PLC for lung cancer, non small cell lung cancer, and solid tumours.