Assessing An Oral Janus Kinase Inhibitor, AZD4205 as Monotherapy in Patients Who Have PTCL (JACKPOT8)

Part A and Part B: Number of Participants With Adverse Events

To evaluate the safety and tolerability of AZD4205 in patients with PTCL in terms of adverse events (AEs), such as number of participants with AEs

Time frame: The first dose until 28 days after last dose, up to approximately 3 years

Part B: Duration of Response (DoR) Assessed by IRC

DoR is the time from the date of first documented response until the date of documented progression or death due to any cause. Documented response and progression are both identified based on CT scans evaluated by IRC per Lugano criteria.

Time frame: Up to approximately 3 years

Part B: Complete Response Rate (CRR) Assessed by IRC

CRR is the percentage of patients with at least one visit response of CR based on CT scans evaluated by IRC per Lugano criteria.

Time frame: Up to approximately 3 years

Part B: Progression Free Survival (PFS) Assessed by IRC

PFS is the time from the date of first dosing until the date of objective disease progression or death (by any cause) regardless of whether the participant discontinues the study treatments. Progression is identified based on CT scans evaluated by IRC per Lugano criteria.

Time frame: Up to approximately 3 years

Part B: Time to Response (TTR) Assessed by IRC

TTR is the time from the date of first dosing to the time of the initial response of PR or CR. Response is identified based on CT scans evaluated by IRC per Lugano criteria.

Time frame: Up to approximately 3 years

Part A and Part B: ORR Assessed by Investigator

ORR is the percentage of patients with at least one visit response of CR or PR based on CT and/or PET scans evaluated by investigator per Lugano criteria.

Time frame: Up to approximately 3 years

Part A and Part B: DoR Assessed by Investigator

DoR is the time from the date of first documented response until the date of documented progression or death due to any cause. Documented response and progression are both identified based on CT and/or PET scans evaluated by investigator per Lugano criteria.

Time frame: Up to approximately 3 years

Part A and Part B: CRR Assessed by Investigator

CRR is the percentage of patients with at least one visit response of CR based on CT and/or PET scans evaluated by investigator per Lugano criteria.

Time frame: Up to approximately 3 years

Part A and Part B: PFS Assessed by Investigator

PFS is the time from the date of first dosing until the date of objective disease progression or death (by any cause) regardless of whether the participant discontinues the study treatments. Progression is identified based on CT and/or PET scans evaluated by investigator per Lugano criteria.

Time frame: Up to approximately 3 years

Part B: TTR Assessed by Investigator

TTR is the time from the date of first dosing to the time of the initial response of PR or CR. Response is identified based on CT scans evaluated by investigator per Lugano criteria.

Time frame: Up to approximately 3 years

Part A and Part B: Maximum Plasma Concentration (Cmax) of AZD4205

Maximum observed plasma concentration, obtained directly from the observed concentration versus time data. Calculated for the single dose.

Time frame: Cycle 1 Day 1 (each cycle = 21 days): 0 (predose), 0.5, 1, 1.5, 2, 2.5, 3, 4, 6, 8, 10, and 24 hours postdose (for Group A, B and C); 0 (predose), 1, 2, 4, 6, 8, and 24 hours postdose (for Group D).

Part A and Part B: Area Under the Plasma Concentration-time Curve From Zero to the Last Measurable Concentration (AUC0-t) of AZD4205

Area under the plasma concentration-time curve from time zero to the last quantifiable time point, calculated by the linear up/log down rule.

Time frame: Cycle 1, Day 1 (each cycle = 21 days): 0 (predose), 0.5, 1, 1.5, 2, 2.5, 3, 4, 6, 8, 10, and 24 hours postdose (for Group A, B and C); 0 (predose), 1, 2, 4, 6, 8, and 24 hours postdose (for Group D).

Part A and Part B: Cmax,ss, at Steady State of AZD4205

Maximum observed plasma concentration (ng/mL) at steady state, obtained directly from the observed concentration versus time data. Calculated for the multiple doses.

Time frame: Cycle 2 Day 1 (each cycle = 21 days): 0 (predose), 0.5, 1, 1.5, 2, 2.5, 3, 4, 6, 8, 10, and 24 hours postdose (for Group A, B and C); 0 (predose), 1, 2, 4, 6, 8, and 24 hours postdose (for Group D).

Part A and Part B: AUCss, at Steady State of AZD4205

Area under the plasma concentration-time curve from time zero to the last quantifiable time point at steady state, calculated by the linear up/log down rule

Time frame: Cycle 2 Day 1 (each cycle = 21 days): 0 (predose), 0.5, 1, 1.5, 2, 2.5, 3, 4, 6, 8, 10, and 24 hours postdose (for Group A, B and C); 0 (predose), 1, 2, 4, 6, 8, and 24 hours postdose (for Group D).