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RecruitingLast updated: 26 April 2022

This phase I/II study is trying to determine the appropriate dosing of a targeted therapy (AZD4573) alone, and then evaluate how effective it is when combined with another targeted therapy (acalabrutinib), in people with advanced blood cancersA Modular Phase I/II, Open-label, Multicentre Study to Assess AZD4573 in Novel Combinations With Anti-cancer Agents in Patients With Advanced Haematological Malignancies

Clinical summary

Summary

This is a non-randomised trial that has two modules, each with two parts. In Module 1 Part A, participants will receive ascending doses of AZD4573 (administered intravenously [via IV]) once weekly, in combination with oral, twice daily doses of acalabrutinib. Part A will have three different cohorts, each with different target dose levels of AZD4573. The primary objective of Part A is to determine the maximum tolerated dose for Part B. In Module 1 Part B, participants will receive AZD4573 at the dose level determined in Part A. Module 2 Part A has two phases. In Phase 1, participants will receive AZD4573 alone (administered via IV once weekly). In Phase 2, participants will receive AZD4573 (administered via IV once weekly) in combination with acalabrutinib (orally, twice daily). Module 2 Part B will be determined based on the data that emerges from Part A.

Conditions

This trial is treating patients with advanced blood cancers, including Diffuse large B-cell lymphoma, Marginal zone lymphoma, Germinal Centre B-cell lymphoma, non-GCB Diffuse large B-cell lymphoma and Mantle Cell Lymphoma.

Cancer

Blood Cancers Blood

Age

People18 - 130

Phase

I/II

More information

Trial Identifiers

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Commercial Sponsor

AstraZeneca

Scientific Title

A Modular Phase I/II, Open-label, Multicentre Study to Assess AZD4573 in Novel Combinations With Anti-cancer Agents in Patients With Advanced Haematological Malignancies

Eligibility

Inclusion

  • You are able to swallow medication by mouth.
  • You have had treatment but your cancer has gotten worse or has not responded to the treatment you have been given.
  • You have had treatment, but your cancer has come back.

Exclusion

  • You have certain types of non-cancer medical conditions.
  • You have had certain treatments, surgical procedures or drugs.
Message

Clinical trials have complex eligibility criteria.

Ask your doctor if this trial could be right for you.

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