NCT03328273

Brief Summary

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

Trial Health

78
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
12

participants targeted

Target at below P25 for phase_1

Timeline
3mo left

Started Jan 2018

Longer than P75 for phase_1

Geographic Reach
2 countries

11 active sites

Status
active not recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Progress96%
Jan 2018Aug 2026

First Submitted

Initial submission to the registry

October 30, 2017

Completed
2 days until next milestone

First Posted

Study publicly available on registry

November 1, 2017

Completed
3 months until next milestone

Study Start

First participant enrolled

January 31, 2018

Completed
3.6 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 7, 2021

Completed
5 years until next milestone

Study Completion

Last participant's last visit for all outcomes

August 26, 2026

Expected
Last Updated

April 20, 2026

Status Verified

April 1, 2026

Enrollment Period

3.6 years

First QC Date

October 30, 2017

Last Update Submit

April 17, 2026

Conditions

Chronic Lymphocytic Leukemia

Outcome Measures

Primary Outcomes (1)

  • Number of participants experiencing dose-limiting toxicities

    Arm A (discontinued): When given as monotherapy in subjects with R/R high-risk CLL who have exhausted other therapeutic options according to local/regional standard of care. Arm B: Ceralasertib given in combination with acalabrutinib in subjects with R/R high-risk CLL who are suitable for treatment with a BTK inhibitor and ceralasertib, per investigator's clinical opinion.

    28 Days

Study Arms (2)

Arm A Part 1 and 2

OTHER

DISCONTINUED (ceralasertib monotherapy)

Drug: Ceralasertib

Arm B Part 1 and 2

EXPERIMENTAL

ceralasertib + acalabrutinib in combination

Drug: CeralasertibDrug: Acalabrutinib

Interventions

CeralasertibDRUG

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

Also known as: AZD6738
Arm A Part 1 and 2Arm B Part 1 and 2
AcalabrutinibDRUG

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

Also known as: ACP196
Arm B Part 1 and 2

Eligibility Criteria

Age18 Years - 130 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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.

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (11)

Research Site

Krakow, 30-510, Poland

Location

Research Site

Lodz, 93-510, Poland

Location

Research Site

Birmingham, B9 5SS, United Kingdom

Location

Research Site

Bournemouth, BH7 7DW, United Kingdom

Location

Research Site

Cardiff, CF14 4XW, United Kingdom

Location

Research Site

Leeds, LS9 7TF, United Kingdom

Location

Research Site

London, NW1 2PG, United Kingdom

Location

Research Site

London, SE5 9RS, United Kingdom

Location

Research Site

Nottingham, NG5 1PB, United Kingdom

Location

Research Site

Oxford, OX3 7LJ, United Kingdom

Location

Research Site

Southampton, SO16 6YD, United Kingdom

Location

Related Publications (1)

  • Jurczak W, Elmusharaf N, Fox CP, Townsend W, Paulovich AG, Whiteaker JR, Krantz F, Wun CC, Parr G, Sharma S, Munugalavadla V, Manwani R, Dean E, Munir T. Phase I/II results of ceralasertib as monotherapy or in combination with acalabrutinib in high-risk relapsed/refractory chronic lymphocytic leukemia. Ther Adv Hematol. 2023 May 30;14:20406207231173489. doi: 10.1177/20406207231173489. eCollection 2023.

    PMID: 37273420DERIVED

Related Links

MeSH Terms

Conditions

Leukemia, Lymphocytic, Chronic, B-Cell

Interventions

ceralasertibacalabrutinib

Condition Hierarchy (Ancestors)

Leukemia, B-CellLeukemia, LymphoidLeukemiaNeoplasms by Histologic TypeNeoplasmsHematologic DiseasesHemic and Lymphatic DiseasesLymphoproliferative DisordersLymphatic DiseasesImmunoproliferative DisordersImmune System DiseasesChronic DiseaseDisease AttributesPathologic ProcessesPathological Conditions, Signs and Symptoms

Study Officials

  • Acerta Clinical Trials

    1-888-292-9613; acertamc@dlss.com

    STUDY DIRECTOR

Study Design

Study Type
interventional
Phase
phase 1
Allocation
NON RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

October 30, 2017

First Posted

November 1, 2017

Study Start

January 31, 2018

Primary Completion

September 7, 2021

Study Completion (Estimated)

August 26, 2026

Last Updated

April 20, 2026

Record last verified: 2026-04

Data Sharing

IPD Sharing
Will share

Qualified researchers can request access to anonymized individual patient-level data from AstraZeneca group of companies sponsored clinical trials via the request portal. All request will be evaluated as per the AZ disclosure commitment: https://astrazenecagrouptrials.pharmacm.com/ST/Submission/Disclosure. Yes, indicates that AZ are accepting requests for IPD, but this does not mean all requests will be shared.

Shared Documents
STUDY PROTOCOL, SAP
Time Frame
AstraZeneca will meet or exceed data availability as per the commitments made to the EFPIA Pharma Data Sharing Principles. For details of our timelines, please rerefer to our disclosure commitment at https://astrazenecagrouptrials.pharmacm.com/ST/Submission/Disclosure.
Access Criteria
When a request has been approved AstraZeneca will provide access to the deidentified individual patient-level data in an approved sponsored tool . Signed Data Sharing Agreement (non-negotiable contract for data accessors) must be in place before accessing requested information. Additionally, all users will need to accept the terms and conditions of the SAS MSE to gain access. For additional details, please review the Disclosure Statements at https://astrazenecagrouptrials.pharmacm.com/ST/Submission/Disclosure.
More information

Locations

GB(9)PL(2)