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AZD3759 · 1 trial · 1 indication
Adverse events will be collected from Informed consent until the end of the follow-up period which is defined as 28 days (+7 days) after study treatment is discontinued.Physical exam (screening, single dosing day, Day 1 of every 3-week cycle of multiple dosing and treatment discontinuation). ECG and vital signs (screening, Day 1 and 2 of Cycle 0 for AZD3759 cohorts, Day 8 of Cycle 1 for AZD3759 cohorts, Day 1 of every 3-week cycle, treatment discontinuation, and if occurrence of any cardiac adverse event). Lab variables (screening, first dosing day, Day 1, 8 and 15 of multiple dosing, Day 1 of every 3-week cycle and treatment discontinuation). Eye exam (at screening and study drug discontinuation and upon occurrence of any visual AE). Echocardiogram or multigated radionuclide angiography (at screening,whenever necessary as clinically indicated throughout the study for AZD3759 cohorts.
| Arm | Type | Description |
|---|---|---|
| Daily dose of AZD3759 | EXPERIMENTAL | Daily oral dose of AZD3759 |
| Daily Dose of AZD9291 | EXPERIMENTAL | Daily oral dose of AZD9291 |
| Name | Type | Description |
|---|---|---|
| AZD3759 | DRUG | Starting dose 50 mg, administered twice daily. If tolerated subsequent cohorts will test increasing doses of AZD3759, until a maximum tolerated dose or an effective dose is defined |
| AZD9291 | DRUG | AZD9291 160mg once daily |
Inclusion Criteria: 1. Obtained written informed consent 2. Male or female aged at least 18 years. Aged at least 20 if Japanese. 3. Histologically or cytologically confirmed diagnosis of NSCLC with single activating EGFR mutations (L858R or Exon19Del). 4. Eastern Cooperative Oncology Group performa...
AZD3759 is an investigational small molecule being studied for the treatment of EGFR mutation positive advanced non small cell lung cancer. It is an oral epidermal growth factor receptor tyrosine kinase inhibitor. The drug is currently in clinical development and has not been approved by regulatory authorities.
AZD3759 targets the epidermal growth factor receptor (EGFR), specifically in patients with EGFR mutation positive advanced non small cell lung cancer. As a tyrosine kinase inhibitor, it works by blocking the activity of EGFR, which is involved in cancer cell growth and survival.
AZD3759 is being developed by AstraZeneca PLC, a biopharmaceutical company listed on the stock exchange under the ticker symbol AZN. The company is conducting clinical trials to evaluate the drug's safety and efficacy in patients with EGFR mutation positive advanced non small cell lung cancer.
AZD3759 is in Phase 1 clinical development. A Phase 1 trial has been completed, involving 108 patients with EGFR mutation positive advanced non small cell lung cancer. The drug remains investigational and is not yet approved for commercial use.
AZD3759 has been studied in one clinical trial with the identifier NCT02228369. This Phase 1 trial, titled 'Oral Epidermal Growth Factor Receptor Tyrosine Kinase Inhibitors, AZD3759 or AZD9291, in Patients Who Have Advanced Non-Small Cell Lung Cancer,' has been completed. The trial enrolled 108 patients across the United States, Australia, South Korea, and Taiwan.
AZD3759 is not the same as AZD9291. They are two distinct oral epidermal growth factor receptor tyrosine kinase inhibitors that were studied together in a single clinical trial (NCT02228369) for advanced non small cell lung cancer. Each drug is being evaluated separately for its safety and efficacy.