AstraZeneca Clinical Study Information Center Kontakt: Phone: 1-877-240-9479 E-Mail: information.center@astrazeneca.com» Kontaktdaten anzeigen
Studienlocations (3 von 17)
Research Site 50937 Köln (Nordrhein-Westfalen) GermanyNoch nicht rekrutierend» Google-MapsResearch Site 33136 Miami United StatesNoch nicht rekrutierend» Google-MapsResearch Site 30322 Atlanta United StatesZurückgezogen» Google-Maps
Research Site 02215 Boston United StatesNoch nicht rekrutierend» Google-MapsResearch Site 77030 Houston United StatesNoch nicht rekrutierend» Google-MapsResearch Site 6009 Nedlands AustraliaNoch nicht rekrutierend» Google-MapsResearch Site 94010 Creteil FranceNoch nicht rekrutierend» Google-MapsResearch Site 69310 Pierre Benite FranceNoch nicht rekrutierend» Google-MapsResearch Site 15100 Alessandria ItalyNoch nicht rekrutierend» Google-MapsResearch Site 40138 Bologna ItalyNoch nicht rekrutierend» Google-MapsResearch Site 20141 Milan ItalyNoch nicht rekrutierend» Google-MapsResearch Site 03080 Seoul Korea, Republic ofRekrutierend» Google-MapsResearch Site 06351 Seoul Korea, Republic ofRekrutierend» Google-MapsResearch Site 08908 L'Hospitalet de Llobregat SpainNoch nicht rekrutierend» Google-MapsResearch Site 28041 Madrid SpainNoch nicht rekrutierend» Google-MapsResearch Site M20 4BX Manchester United KingdomNoch nicht rekrutierend» Google-MapsResearch Site OX3 7LE Oxford United KingdomNoch nicht rekrutierend» Google-Maps
1. Incidence and severity of adverse events (AEs) and serious adverse events (SAEs) (Time Frame - From Screening until 28 days after the last dose of study medication.): AEs: Number of patients with adverse events by system organ class and preferred term.
SAEs: Number of patients with serious adverse events by system organ class and preferred term.
2. Incidence of DLTs (Dose Escalation only) (Time Frame - From first dose of AZD3470 to end of Cycle 1 (each cycle is 21 days).): In the Dose Escalation cohorts in Part A, the number of participants with at least 1 dose-limiting toxicity (DLT), which is any toxicity defined as a DLT in the Clinical Study Protocol
Secondary outcome:
1. Part A and Part B: Response endpoints - Objective Response Rate (ORR)/Complete Response Rate (CRR) (Time Frame - From first dose (Cycle 1 Day 1, each cycle is 21 days) until disease progression or the last evaluable assessment in the absence of progression (assessed approximately up to 2 years)): ORR is defined as the proportion of participants who have a CR or PR and CRR is defined as the proportion of participants who have a CR.
Assessment of ORR/CRR will be done according to the Lugano Classification for cHL.
2. Part A and Part B: Response endpoints - Duration of Response (DoR) (Time Frame - From first dose (Cycle 1 Day 1, each cycle is 21 days) until disease progression or death, whichever comes first (assessed approximately up to 2 years).): The time from the date of first documented response until the date of documented progression as assessed by the investigator according to the Lugano classification for cHL, or death due to any cause
3. Part A and Part B: Progression-free Survival (PFS) (Time Frame - Non-randomized study parts: from first dose (each cycle is 21 days) until disease progression or death, whichever comes first. Randomized parts: from date of randomization until disease progression or death, whichever comes first. (Approx up to 2 years)): Time from date of first dose (non- randomised study parts) or date of randomization (randomised study parts) until progression as assessed by the investigator according to the Lugano Classification for cHL, or death due to any cause.
4. Part A and Part B: Overall Survival (OS) (Time Frame - Non-randomized study parts: From first dose (Cycle 1 Day 1, each cycle is 21 days) until death. Randomized study parts: from date of randomization until the date of death due to any cause (assessed approximately up to 2 years).): Time from date of first dose (non-randomised study parts) or date of randomization (randomised study parts) until the date of death due to any cause.
5. Part A and Part B: Maximum observed plasma drug concentration (Cmax) (Time Frame - From Cycle 1 Day 1 (each cycle is 21 days) to EoT, at predefined intervals throughout the treatment period (for each patient this is expected to be approximately 6 months).): Assessed to characterize the plasma PK profile of AZD3470.
6. Part A: Dose normalised maximum observed plasma drug concentration (Cmax) (Time Frame - From Cycle 1 Day 1 (each cycle is 21 days) to EoT, at predefined intervals throughout the treatment period (for each patient this is expected to be approximately 6 months).): Assessed to characterize the plasma PK profile of AZD3470.
7. Part A: Accumulation ratio for maximum observed plasma drug concentration (Cmax) (Time Frame - From Cycle 1 Day 1 (each cycle is 21 days) to EoT, at predefined intervals throughout the treatment period (for each patient this is expected to be approximately 6 months).): Assessed to characterize the plasma PK profile of AZD3470.
8. Part A and Part B: Minimum observed plasma drug concentration (Cmin) (Time Frame - From Cycle 1 Day 1 (each cycle is 21 days) to EoT, at predefined intervals throughout the treatment period (for each patient this is expected to be approximately 6 months).): Assessed to characterize the plasma PK profile of AZD3470.
9. Part A and Part B: Time to reach peak or maximum observed concentration following drug administration (Tmax) (Time Frame - From Cycle 1 Day 1 (each cycle is 21 days) to EoT, at predefined intervals throughout the treatment period (for each patient this is expected to be approximately 6 months).): Assessed to characterize the plasma PK profile of AZD3470.
10. Part A and Part B: Area under the plasma concentration-curve over the dosing interval (AUCtau) (Time Frame - From Cycle 1 Day 1 (each cycle is 21 days) to EoT, at predefined intervals throughout the treatment period (for each patient this is expected to be approximately 6 months).): Assessed to characterize the plasma PK profile of AZD3470.
11. Part A: Dose normalized area under the plasma concentration-curve over the dosing interval (AUCtau) (Time Frame - From Cycle 1 Day 1 (each cycle is 21 days) to EoT, at predefined intervals throughout the treatment period (for each patient this is expected to be approximately 6 months).): Assessed to characterize the plasma PK profile of AZD3470.
12. Part A: Accumulation ratio for area under the plasma concentration-curve over the dosing interval (AUCtau) (Time Frame - From Cycle 1 Day 1 (each cycle is 21 days) to EoT, at predefined intervals throughout the treatment period (for each patient this is expected to be approximately 6 months).): Assessed to characterize the plasma PK profile of AZD3470.
13. Part A: Cumulative amount (%) of drug recovered unchanged in urine during dosing interval (Ae,tau) (Time Frame - From Cycle 1 Day 1 to end of Cycle 1 at predefined intervals throughout the cycle (each cycle is 21 days).): Assessed to characterize the urine PK profile of AZD3470.
14. Part A: Renal clearance (Clr) (Time Frame - From Cycle 1 Day 1 to end of Cycle 1 at predefined intervals throughout the cycle (each cycle is 21 days).): Assessed to characterize the urine PK profile of AZD3470.
15. Part B: Ratio of maximum observed plasma drug concentration (Cmax) under fed/fasted state (Time Frame - From Cycle 1 Day 1 to Cycle 2 Day 1 at predefined intervals (each cycle is 21 days).): Preliminary food effect on plasma PK of AZD3470 administered as a monotherapy in participants enrolled in dose expansion.
16. Part B: Time to reach peak or maximum observed concentration following drug administration (Tmax) under fed conditions (Time Frame - From Cycle 1 Day 1 to Cycle 2 Day 1 at predefined intervals (each cycle is 21 days).): Preliminary food effect on plasma PK of AZD3470 administered as a monotherapy in participants enrolled in dose expansion.
17. Part B: Time to reach peak or maximum observed concentration following drug administration (Tmax) under fasted conditions (Time Frame - From Cycle 1 Day 1 to Cycle 2 Day 1 at predefined intervals (each cycle is 21 days).): Preliminary food effect on plasma PK of AZD3470 administered as a monotherapy in participants enrolled in dose expansion.
18. Part B: Ratio of area under the plasma concentration-curve over the dosing interval (AUCtau) under fed/fasted state (Time Frame - From Cycle 1 Day 1 to Cycle 2 Day 1 at predefined intervals (each cycle is 21 days).): Preliminary food effect on plasma PK of AZD3470 administered as a monotherapy in participants enrolled in dose expansion.
