Overview

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

Status:
Active, not recruiting
Trial end date:
2023-06-30
Target enrollment:
0
Participant gender:
All
Summary
This study evaluates the safety, pharmacokinetics, pharmacodynamics and efficacy of acalabrutinib and ceralasertib (known as AZD6738) when taken in combination.
Phase:
Phase 1
Accepts Healthy Volunteers?
No
Details
Lead Sponsor:
AstraZeneca
Treatments:
Acalabrutinib
Criteria
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