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
Effectiveness Progress
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
Safety Progress
Side Effects for
BSC Alone
2%Headache
1%Septic shock
1%Ischaemic stroke
1%Chronic obstructive pulmonary disease
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.
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Conditions
Cancer Related
Treatments