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

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ClinicalTrials.gov Identifier: NCT03328273
Recruitment Status : Recruiting
First Posted : November 1, 2017
Last Update Posted : November 22, 2018
Sponsor:
Information provided by (Responsible Party):
Acerta Pharma BV

Brief Summary:
This study evaluates the safety of acalabrutinib and AZ6738 when taken in combination.

Condition or disease Intervention/treatment Phase
Chronic Lymphocytic Leukemia Drug: AZD6738 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 : January 2020
Estimated Study Completion Date : April 2020


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

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

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




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


Information from the National Library of Medicine

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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).

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
United Kingdom
Royal Bournemouth Hospital Recruiting
Bournemouth, United Kingdom, BH7 7DW
University Hospital of Wales Recruiting
Cardiff, United Kingdom, CF14 4XW
Nottingham University Hospital Recruiting
Nottingham, United Kingdom, NG5 1PB
Oxford University Hospitals NHS Foundation Recruiting
Oxford, United Kingdom, OX3 9DU
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     History of Changes
Other Study ID Numbers: ACE-CL-110
First Posted: November 1, 2017    Key Record Dates
Last Update Posted: November 22, 2018
Last Verified: November 2018

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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