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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 oral therapy being studied for EGFR mutation positive advanced non small cell lung cancer. It is a small molecule developed by AstraZeneca PLC (ticker AZN) and has been evaluated in a Phase 1 clinical trial in patients with this biomarker-selected form of lung cancer.
AZD3759 targets EGFR, the epidermal growth factor receptor. It is classified as an EGFR inhibitor, meaning it is designed to block signaling through this receptor. The drug is being studied specifically in patients whose tumors carry EGFR mutations, which is why the trial enrolled a biomarker-selected population.
AZD3759 is being developed by AstraZeneca PLC, which trades under the ticker AZN. AstraZeneca is the sponsor of the clinical program evaluating the drug in EGFR mutation positive advanced non small cell lung cancer.
AZD3759 is in Phase 1 clinical development. It has not been approved by the FDA and remains investigational. The Phase 1 trial that evaluated the drug has been completed, and no active trials are currently listed for this asset.
AZD3759 was evaluated in the Phase 1 trial NCT02228369, titled Oral Epidermal Growth Factor Receptor Tyrosine Kinase Inhibitors, AZD3759 or AZD9291, in Patients Who Have Advanced Non-Small Cell Lung Cancer. The completed study enrolled 108 patients across the United States, Australia, South Korea, and Taiwan.