| NCT ID | Title | Phase | Status | Enrollment | Velocity | Design | Start | Completion | Last Updated | Sites | Countries |
|---|---|---|---|---|---|---|---|---|---|---|---|
| NCT01791595 | A Phase I Trial of AZD3965 in Patients With Advanced Cancer | PHASE1 | COMPLETED | 53 | — | — | Apr 23, 2013 | Nov 17, 2020 | Apr 11, 2022 | 7 | United Kingdom |
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...