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Label indication TAGRISSO is a kinase inhibitor indicated for: • adjuvant therapy after tumor resection in adult patients with non-small cell lung cancer (NSCLC) whose tumors have epidermal growth factor receptor (EGFR) exon 19 deletions or exon 21 L858R mutations, as detected by an FDA-approved test. FDA label
Also known as TAGRISSO™
Osimertinib; AZD9291 · 1 trial · 1 indication
Part A: To investigate the PK of osimertinib after a single oral dose of 80 mg in patients with advanced solid tumours and normal renal function or severe renal impairment.
Part A: To investigate the PK of osimertinib after a single oral dose of 80 mg in patients with advanced solid tumours and normal renal function or severe renal impairment.
| Arm | Type | Description |
|---|---|---|
| Normal renal function | EXPERIMENTAL | For inclusion in the study as a patient with normal renal function, patients must have creatinine clearance ≥90 mL/min. |
| Severe renal impairment | EXPERIMENTAL | For inclusion in the study as a patient with severe renal impairment, patients must have stable severe renal impairment (creatinine clearance \<30 mL/min), as defined by the Cockcroft Gault equation, for at least 2 months prior to Day 1. |
| Name | Type | Description |
|---|---|---|
| Osimertinib; AZD9291 | DRUG | 80mg tablet dose to be taken orally - single dose in part A, daily dosing in Part B and continued access until progression or no longer receiving benefit |
Inclusion criteria: 1. For inclusion as a patient with severe renal impairment patient must have stable severe renal impairment (CrCl \<30 mL/min at screening), for at least 2 months prior to the study. 2. For inclusion as a patient with normal renal function, patient must have CrCl ≥90 mL/min at s...
| Company | Ticker | Trials | Lead Phase | Drugs |
|---|---|---|---|---|
| Merck & Co., Inc. | MRK | 3 | PHASE2 | Pembrolizumab, Gardasil 9 |
| Incyte Corporation | INCY | 1 | PHASE2 | Retifanlimab |
| Novartis AG Sponsored ADR | NVS | 1 | PHASE1 | KFA115 |
| Iovance Biotherapeutics Inc | IOVA | 2 | PHASE2 | Aldesleukin |
| AstraZeneca PLC | AZN | 1 | - | Trastuzumab deruxtecan |
Osimertinib is an investigational small molecule being studied in solid tumours. A Phase 1 trial evaluated it in patients with advanced solid tumours who had either normal kidney function or severe kidney impairment. It is being developed by AstraZeneca PLC under the ticker AZN.
Osimertinib is developed by AstraZeneca PLC, which trades under the ticker AZN. The company is the sponsor of the clinical program studying the drug in advanced solid tumours, including a Phase 1 trial conducted in France, South Korea, and Spain.
Osimertinib is in Phase 1 development for solid tumours. The Phase 1 study, NCT02923947, has been completed. It enrolled 16 patients and assessed the drug in adults with advanced solid tumours who had normal kidney function or severe kidney impairment.
Osimertinib has been studied in the Phase 1 trial NCT02923947, titled Study to Assess Osimertinib in Patients w/ Adv Solid Tumours & Normal Kidney Function or Severe Kidney Impairment. The trial enrolled 16 adults, was controlled, and has been completed. It ran in France, South Korea, and Spain.
Yes, AZD9291 is an alternative name for osimertinib. Both names refer to the same AstraZeneca small molecule developed for solid tumours. The Phase 1 trial NCT02923947 studied the drug in patients with advanced solid tumours and either normal kidney function or severe kidney impairment.
The Phase 1 trial NCT02923947 was a controlled study of osimertinib in adults with advanced solid tumours and either normal kidney function or severe kidney impairment. It enrolled 16 participants of any sex, aged 18 years and older, across France, South Korea, and Spain, and has been completed.