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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
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.
Minimum Age: 18 Years
Eligible Ages: ADULT, OLDER_ADULT
Sex: ALL
Healthy Volunteers: No
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
Name: Acerta Clinical Trials
Affiliation: 1-888-292-9613; acertamc@dlss.com
Role: STUDY_DIRECTOR