AZD4573 for Advanced Blood Cancers

Phase-Based Progress Estimates
1
Effectiveness
1
Safety
Advanced Blood CancersAZD4573 - Drug
Eligibility
18 - 130
All Sexes
What conditions do you have?
Select

Study Summary

This trial is testing a new cancer drug, given in combination with other anti-cancer agents, to people with cancer that has come back or did not respond to other treatments.

Eligible Conditions
  • Advanced Blood Cancers

Treatment Effectiveness

Study Objectives

3 Primary · 18 Secondary · Reporting Duration: Cycle 1 (5 weeks in total) on Day 1 of Week 1, 2 and 3, and Cycle 2 (3 weeks in total) on Day 1 of Week 1

Week 5
Module 1 Part A and Part B: Plasma PK (AUC0-t) of AZD4573 and acalabrutinib (plus its active metabolite ACP-5862), when given in combination
Module 1 Part A and Part B: Plasma PK (AUCinf) of AZD4573 and acalabrutinib (plus its active metabolite ACP-5862), when given in combination
Module 1 Part A and Part B: Plasma PK (AUClast) of AZD4573 and acalabrutinib (plus its active metabolite ACP-5862), when given in combination
Module 1 Part A and Part B: Plasma PK (t1/2) of AZD4573 and acalabrutinib (plus its active metabolite ACP-5862), when given in combination
Module 1 Part A and Part B: Plasma PK (tmax) of AZD4573 and acalabrutinib (plus its active metabolite ACP-5862), when given in combination
Module 1 Part A and Part B: Plasma pharmacokinetics (PK) (Cmax) of AZD4573 and acalabrutinib (plus its active metabolite ACP-5862), when given in combination
Module 1 Part A and Part B; Module 2 Part A: Plasma PK (AUC0-t) of AZD4573 (given as monotherapy for Module 2 only) and acalabrutinib (plus its active metabolite ACP-5862), when given in combination
Module 1 Part A and Part B; Module 2 Part A: Plasma PK (AUCinf) of AZD4573 (given as monotherapy for Module 2 only) and acalabrutinib (plus its active metabolite ACP-5862), when given in combination
Module 1 Part A and Part B; Module 2 Part A: Plasma PK (AUClast) of AZD4573 (given as monotherapy for Module 2 only) and acalabrutinib (plus its active metabolite ACP-5862), when given in combination
Module 1 Part A and Part B; Module 2 Part A: Plasma PK (t1/2) of AZD4573 (given as monotherapy for Module 2 only) and acalabrutinib (plus its active metabolite ACP-5862), when given in combination
Module 1 Part A and Part B; Module 2 Part A: Plasma PK (tmax) of AZD4573 (given as monotherapy for Module 2 only) and acalabrutinib (plus its active metabolite ACP-5862), when given in combination
Module 1 Part A and Part B; Module 2 Part A: Plasma pharmacokinetics (PK) (Cmax) of AZD4573 (given as monotherapy for Module 2 only) and acalabrutinib (plus its active metabolite ACP-5862), when given in combination
Month 6
Module 1 Part A : Number of participants with serious and non-serious adverse events
Module 1 Part B: Efficacy of AZD4573 in combination with acalabrutinib by evaluation of tumour response and overall survival via CR rate
Module 1 Part B: Efficacy of AZD4573 in combination with acalabrutinib by evaluation of tumour response and overall survival via Overall survival (OS)
Module 1 Part B: Efficacy of AZD4573 in combination with acalabrutinib by evaluation of tumour response and overall survival via Progression free survival (PFS)
Module 1 Part B: Efficacy of AZD4573 in combination with acalabrutinib by evaluation of tumour response and overall survival via Time to Response (TTR)
Module 1 Part B: Efficacy of AZD4573 in combination with acalabrutinib by evaluation of tumour response and overall survival via duration of response (DoR)
Module 1 Part B: Number of participants with serious and non-serious adverse events
Module 1 Part B: Overall response rate (ORR) of AZD4573 in combination with acalabrutinib
Module 2 Part A : Number of participants with serious and non-serious adverse events

Trial Safety

Side Effects for

BSC Alone
2%Headache
1%Septic shock
1%Ischaemic stroke
1%Chronic obstructive pulmonary disease
This histogram enumerates side effects from a completed 2020 Phase 2 trial (NCT04346199) in the BSC Alone ARM group. Side effects include: Headache with 2%, Septic shock with 1%, Ischaemic stroke with 1%, Chronic obstructive pulmonary disease with 1%.

Trial Design

3 Treatment Groups

Module 2: Part A and Part B
1 of 3
AZD4573: Cohorts 1, 2, and 3
1 of 3
Module 1: Part A and Part B
1 of 3

Experimental Treatment

117 Total Participants · 3 Treatment Groups

Primary Treatment: AZD4573 · No Placebo Group · Phase 1 & 2

Module 2: Part A and Part BExperimental Group · 2 Interventions: AZD4573, Acalabrutinib · Intervention Types: Drug, Drug
AZD4573: Cohorts 1, 2, and 3Experimental Group · 2 Interventions: AZD4573, Acalabrutinib · Intervention Types: Drug, Drug
Module 1: Part A and Part BExperimental Group · 2 Interventions: AZD4573, Acalabrutinib · Intervention Types: Drug, Drug
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
AZD4573
2017
Completed Phase 1
~50
Acalabrutinib
FDA approved

Trial Logistics

Trial Timeline

Screening: ~3 weeks
Treatment: Varies
Reporting: cycle 1 (5 weeks in total) on day 1 of week 1, 2 and 3, and cycle 2 (3 weeks in total) on day 1 of week 1

Who is running the clinical trial?

AstraZenecaLead Sponsor
3,993 Previous Clinical Trials
247,418,460 Total Patients Enrolled
ParexelIndustry Sponsor
278 Previous Clinical Trials
96,004 Total Patients Enrolled

Eligibility Criteria

Age 18 - 130 · All Participants · 10 Total Inclusion Criteria

Mark “Yes” if the following statements are true for you:
You must be at least 18 years of age to participate in this study.
You have a performance status of ≤ 2.
You have received at least one prior line of therapy for the treatment of current disease and a clinical study is the best option for next treatment based on prior response and/or tolerability.
Uric acid level < ULN.