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Spots Global Cancer Trial Database for A Study of AZD6738 and Acalabrutinib in Subjects With Relapsed or Refractory Chronic Lymphocytic Leukemia (CLL)

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Trial Identification

Brief Title: A Study of AZD6738 and Acalabrutinib in Subjects With Relapsed or Refractory Chronic Lymphocytic Leukemia (CLL)

Official Title: A Phase 1 Proof-of-Concept Study Investigating AZD6738 Monotherapy and Acalabrutinib in Combination With AZD6738 (ATR Inhibitor) in Subjects With Relapsed or Refractory High-risk Chronic Lymphocytic Leukemia (CLL)

Study ID: NCT03328273

Study Description

Brief Summary: This study evaluates the safety, pharmacokinetics, pharmacodynamics and efficacy of acalabrutinib and ceralasertib (known as AZD6738) when taken in combination.

Detailed Description: This study is to determine the safety of ceralasertib when given as monotherapy (discontinued) and in combination with acalabrutinib in subjects with R/R CLL and in subjects who have few therapeutic options available to them. As such, this study includes a formal DLT assessment of the first 6-12 subjects dosed in Part 1 of the study. In addition, routine and regular safety monitoring will be undertaken during this study to fully assess safety of ceralasertib given as monotherapy and in combination with acalabrutinib, with toxicity assessment and dose reduction guidelines.

Keywords

Eligibility

Minimum Age: 18 Years

Eligible Ages: ADULT, OLDER_ADULT

Sex: ALL

Healthy Volunteers: No

Locations

Research Site, Kraków, , Poland

Research Site, Łódź, , Poland

Research Site, Birmingham, , United Kingdom

Research Site, Bournemouth, , United Kingdom

Research Site, Cardiff, , United Kingdom

Research Site, Leeds, , United Kingdom

Research Site, London, , United Kingdom

Research Site, London, , United Kingdom

Research Site, Nottingham, , United Kingdom

Research Site, Oxford, , United Kingdom

Research Site, Southampton, , United Kingdom

Contact Details

Name: Acerta Clinical Trials

Affiliation: 1-888-292-9613; acertamc@dlss.com

Role: STUDY_DIRECTOR

Useful links and downloads for this trial

Clinicaltrials.gov

Google Search Results

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