Study of AZD4512 Monotherapy or in Combination With Anticancer Agents in Participants With Acute Lymphoblastic Leukemia

No strong warning signs right now. The score counts warning signs; it is not a prediction.

Why this score

Score over time

What counts as success

The trial's main goal(s), called the “primary outcome.”

• Module 1 (Dose Escalation): Number of participants with dose-limiting toxicities (DLTs).

  Measured over: From first dose up to 21 days (DLT period).

• Module 1 (Dose Escalation): Frequency, duration and severity of treatment-emergent adverse events (TEAEs), treatment-related adverse events (TRAEs), and serious adverse events (SAEs)

  Measured over: From date of first dose of AZD4512 up until 30 days post last dose of AZD4512 (on average 6 months, maximum 12 months)

• Module 1 (Dose Escalation): Frequency of dose interruptions, modifications, delays, and discontinuations due to AEs

  Measured over: From date of first dose of AZD4512 up until 30 days post last dose of AZD4512 (on average 6 months, maximum 12 months)

• Module 1 (Dose Escalation): Number of participants with clinically significant changes in laboratory values, ECGs, performance status, and vital signs

  Measured over: From date of first dose of AZD4512 up until 30 days post last dose of AZD4512 (on average 6 months, maximum 12 months)

• Module 2 (Dose Optimization): Overall response rate (ORR) in participants with R/R Ph(-) B-ALL

  Measured over: From date of first dose of AZD4512 up until end of study, up to 38 months

• Module 2 (Dose Optimization): Frequency, duration and severity of treatment-emergent adverse events (TEAEs), treatment-related adverse events (TRAEs), and serious adverse events (SAEs)

  Measured over: From date of first dose of AZD4512 up until 30 days post last dose of AZD4512 (on average 6 months, maximum 12 months)

• Module 2 (Dose Optimization): Frequency of dose interruptions, modifications, delays, and discontinuations due to AEs

  Measured over: From date of first dose of AZD4512 up until 30 days post last dose of AZD4512 (on average 6 months, maximum 12 months)

• Module 2 (Dose Optimization): Number of participants with clinically significant changes in laboratory values, ECGs, performance status, and vital signs

  Measured over: From date of first dose of AZD4512 up until 30 days post last dose of AZD4512 (on average 6 months, maximum 12 months)

Changes Tremor has spotted