A Study of AZD6738 and Acalabrutinib in Subjects With Relapsed or Refractory Chronic Lymphocytic … (NCT03328273) | Clinical Trial Compass
Active — Not RecruitingPhase 1
A Study of AZD6738 and Acalabrutinib in Subjects With Relapsed or Refractory Chronic Lymphocytic Leukemia (CLL)
Poland, United Kingdom12 participantsStarted 2018-01-31
Plain-language summary
This study evaluates the safety, pharmacokinetics, pharmacodynamics and efficacy of acalabrutinib and ceralasertib (known as AZD6738) when taken in combination.
Who can participate
Age range18 Years – 130 Years
SexALL
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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 pro…
What they're measuring
1
Number of participants experiencing dose-limiting toxicities