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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03328273
Recruitment Status : Recruiting
First Posted : November 1, 2017
Last Update Posted : March 4, 2020
Sponsor:
Information provided by (Responsible Party):
Acerta Pharma BV

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

Condition or disease Intervention/treatment Phase
Chronic Lymphocytic Leukemia Drug: Ceralasertib Drug: Acalabrutinib Phase 1 Phase 2

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 62 participants
Allocation: Non-Randomized
Intervention Model: Sequential Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: A Phase 1/2 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)
Actual Study Start Date : January 31, 2018
Estimated Primary Completion Date : February 2022
Estimated Study Completion Date : March 2022


Arm Intervention/treatment
Arm A Part 1
DISCONTINUED (ceralasertib monotherapy)
Drug: Ceralasertib
An ATP competitive, orally bioavailable inhibitor of the Serine/Threonine protein kinase Ataxia Telangiectasia and Rad3 related (ATR).
Other Name: AZD6738

Experimental: Arm B Part 1
ceralasertib + acalabrutinib in combination
Drug: Ceralasertib
An ATP competitive, orally bioavailable inhibitor of the Serine/Threonine protein kinase Ataxia Telangiectasia and Rad3 related (ATR).
Other Name: AZD6738

Drug: Acalabrutinib
An experimental anti-cancer drug and Bruton's tyrosine kinase (BTK) inhibitor.
Other Name: ACP196




Primary Outcome Measures :
  1. Number of participants experiencing dose-limiting toxicities [ Time Frame: 28 Days ]


Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03328273


Contacts
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Contact: Acerta Pharma 1-888-292-9613 acertamc@dlss.com

Locations
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Poland
Malopolskie Centrum Medyczne s.c. Recruiting
Krakow, Poland, 30-510
Wojewodzki Szpital Specjalistyczny im. M. Kopernika w Lodzi Recruiting
Łódź, Poland, 93-510
United Kingdom
Birmingham Heartlands Hospital Recruiting
Birmingham, United Kingdom, B9 5SS
Royal Bournemouth Hospital Recruiting
Bournemouth, United Kingdom, BH7 7DW
University Hospital of Wales Recruiting
Cardiff, United Kingdom, CF14 4XW
Leeds Teaching Hospitals NHS Trust Recruiting
Leeds, United Kingdom, LS9 7TF
University College London (UCL) Recruiting
London, United Kingdom, NW1 2PG
King's College London Recruiting
London, United Kingdom, SE5 9RS
Nottingham University Hospital Recruiting
Nottingham, United Kingdom, NG5 1PB
Southampton University Hospital Recruiting
Southampton, United Kingdom, SO16 6YD
Sponsors and Collaborators
Acerta Pharma BV
Investigators
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Study Director: Acerta Clinical Trials 1-888-292-9613; acertamc@dlss.com
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Responsible Party: Acerta Pharma BV
ClinicalTrials.gov Identifier: NCT03328273    
Other Study ID Numbers: ACE-CL-110
First Posted: November 1, 2017    Key Record Dates
Last Update Posted: March 4, 2020
Last Verified: March 2020

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Product Manufactured in and Exported from the U.S.: No
Additional relevant MeSH terms:
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Leukemia
Leukemia, Lymphoid
Leukemia, Lymphocytic, Chronic, B-Cell
Neoplasms by Histologic Type
Neoplasms
Lymphoproliferative Disorders
Lymphatic Diseases
Immunoproliferative Disorders
Immune System Diseases
Leukemia, B-Cell