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 for the treatment of adult solid tumors, as well as diffuse large B cell lymphoma and Burkitt lymphoma. It is currently in Phase 1 clinical development and is not yet approved by regulatory authorities.
AZD3965 is a small molecule that targets monocarboxylate transporters, specifically MCT1 and MCT2. By inhibiting these transporters, it aims to disrupt the metabolic pathways that cancer cells rely on for energy production, potentially slowing tumor growth.
AZD3965 is being developed by AstraZeneca PLC, a multinational pharmaceutical company. AstraZeneca is listed on the stock exchange under the ticker symbol AZN.
AZD3965 is currently in Phase 1 clinical development. A Phase 1 trial has been completed, and the drug remains investigational, meaning it has not received FDA approval and is still being evaluated for safety and efficacy in humans.
AZD3965 has been studied in a Phase 1 clinical trial with the identifier NCT01791595, titled 'A Phase I Trial of AZD3965 in Patients With Advanced Cancer.' This trial enrolled 53 participants with adult solid tumors, diffuse large B cell lymphoma, or Burkitt lymphoma, and has been completed.
AZD3965 is a unique investigational compound and is not known to be the same as any other marketed drug. It is a small molecule inhibitor of monocarboxylate transporters, and its development is being conducted by AstraZeneca.