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Clinical Trials in the UK / NCT03328273
Active, not recruiting Phase 1

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

NCT03328273 · tracked via the Priya Life Science UK tracker
Sponsor
Acerta Pharma BV
Phase
Phase 1
Started
2018-01-31
Last updated
2026-07-14

Condition(s) studied

Chronic Lymphocytic Leukemia

Investigational drug(s) / intervention(s)

CeralasertibAcalabrutinib

Ceralasertib: An ATP competitive, orally bioavailable inhibitor of the Serine/Threonine protein kinase Ataxia Telangiectasia and Rad3 related (ATR).

Acalabrutinib: An experimental anti-cancer drug and Bruton's tyrosine kinase (BTK) inhibitor.

Study summary

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

Eligibility

Sex
ALL
Min age
18 Years
Max age
130 Years
Healthy volunteers
No
Inclusion Criteria: * Diagnosis of relapsed or refractory CLL that meets published diagnostic criteria (International Workshop on Chronic Lymphocytic Leukemia \[IWCLL\] Hallek 2008) and supported/documented by medical records * Subjects must be Relapse/Refractory high risk CLL and have exhausted other therapeutic options according to local/regional standard of care * Must have received ≥1 prior therapy for treatment of their disease. Exclusion Criteria: * A diagnosis of ataxia telangiectasia * Any prior exposure to an ATR inhibitor or known hypersensitivity to an excipient of the product. * Known history of infection with human immunodeficiency virus (HIV). * A life-threatening illness, medical condition or organ system dysfunction which, in the investigator's opinion, could compromise the subject's safety, interfere with the absorption or metabolism of ACP-196 (acalabrutinib) and/or Ceralasertib * Significant cardiovascular disease such as uncontrolled or symptomatic arrhythmias, congestive heart failure, or myocardial infarction within 6 months of screening, or any Class 3 or 4 cardiac disease as defined by the New York Heart Association Functional Classification, or corrected QT interval (QTc) \> 480 msec. * Malabsorption syndrome, disease significantly affecting gastrointestinal function, or resection of the stomach or small bowel or ulcerative colitis, symptomatic inflammatory bowel disease, or partial or complete bowel obstruction. * Requirement of treatment with proton-pump inhibitors (e.g., omeprazole, esomeprazole, lansoprazole, dexlansoprazole, rabeprazole, or pantoprazole). Subjects receiving proton-pump inhibitors who switch to H2-receptor antagonists or antacids are eligible for enrollment to this study. * Breast feeding or pregnant

Primary outcome measure(s)

Trial sites (11)

FacilityCityRegionStatus
Research Site Krakow Poland
Research Site Lodz 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
Official registry record

This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.

View NCT03328273 on ClinicalTrials.gov ↗ ← All trials in the UK