Approval Probability
TA Base Rate
Adjusted LOA
ML Risk
AZD3965 · 1 trial · 3 indications
MTD was determined by testing increasing AZD3965 doses in Part 1 dose escalation cohorts (Cohorts 1-6) and defined as the total daily dose level below that at which ≥2 out of ≤6 evaluable patients had a dose-limiting toxicity (DLT) during Cycle 1 (including Day -7). DLTs were defined as highly probably/probably AZD3965 related haematological, cardiac, ophthalmic, other Grade 3/4 toxicity, death or drug-related toxicity causing AZD3965 interruption \>2 weeks (see protocol for specific criteria)
Number of patients who experienced protocol-defined DLTs (defined according to NCI CTCAE version 4.02). DLTs were defined as highly probably/probably AZD3965 related haematological, cardiac, ophthalmic, other Grade 3/4 toxicity, death or drug-related toxicity causing AZD3965 interruption \>2 weeks (see protocol for specific criteria)
A serious adverse event (SAE) is any AE, regardless of dose, causality or expectedness, that results in death, is life-threatening, requires in-patient hospitalisation or prolongs existing in-patient hospitalisation, results in persistent or significant incapacity or disability, is a congenital anomaly or birth defect or is any other medically important event. Any ophthalmic and/or cardiac DLT is considered a medically important event and therefore an SAE in this trial. Specific AE terms are provided in the Adverse Events section
A non-serious AE is any untoward medical occurrence that does not meet the serious criteria described for outcome measure 3 above. Specific AE terms are provided in the Adverse Events section
| Arm | Type | Description |
|---|---|---|
| AZD3965 Cohort 1 (5 mg OD) | EXPERIMENTAL | - |
| AZD3965 Cohort 2 (10 mg OD) | EXPERIMENTAL | - |
| AZD3965 Cohort 3 (20 mg OD) | EXPERIMENTAL | - |
| AZD3965 Cohort 4 (30 mg OD) | EXPERIMENTAL | - |
| AZD3965 Cohort 5 (15 mg BD) | EXPERIMENTAL | - |
| AZD3965 Cohort 6 (10 mg BD) | EXPERIMENTAL | - |
| AZD3965 Expansion Cohort (10 mg BD) | EXPERIMENTAL | - |
| Name | Type | Description |
|---|---|---|
| AZD3965 | DRUG | Day -7: single dose of 5 mg AZD3965 orally prior to start of continuous treatment. Cycle 1, Day 1: commenced dosing of 5 mg AZD3965 OD orally for up to 6 28-day cycles. Trial participants benefitting from treatment could continue beyond 6 cycles for as long as they continued to benefit on agreement between the Investigator and the Sponsor. |
Inclusion Criteria: 1. Part 1: * Histologically or cytologically proven advanced solid tumour or lymphoma, refractory to conventional treatment or for which no conventional therapy exists. * Available archived tumour samples. Part 2: * Histologically proven DLBCL or BL, which is relap...
AZD3965 is an investigational small molecule being studied in adults with advanced solid tumors. It was evaluated in a Phase 1 trial that also enrolled patients with diffuse large B cell lymphoma and Burkitt lymphoma. It is not an approved therapy and remains in clinical development.
AZD3965 is being developed by AstraZeneca PLC, which trades under the ticker AZN. The company sponsored the Phase 1 study of the compound in patients with advanced cancer.
AZD3965 is in Phase 1 clinical development. Its single registered trial, NCT01791595, was a Phase 1 study in patients with advanced cancer and is now completed. The drug is investigational and has not been approved for any indication.
AZD3965 has been studied in one registered clinical trial, NCT01791595, titled A Phase I Trial of AZD3965 in Patients With Advanced Cancer. The trial enrolled 53 participants in the United Kingdom and is completed. It was an open-label, non-randomized study in adults aged 18 years and older.
No. AZD3965 is an investigational agent in Phase 1 development and is not approved by the FDA for any indication. Its only registered trial, NCT01791595, has completed, and the compound remains a clinical-stage asset.