A phase 1/2 study with Acalabrutinib and AZD6738 in high risk CLL
Research type
Research Study
Full 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).
IRAS ID
231276
Contact name
Anita Sarma
Contact email
Sponsor organisation
Acerta Pharma BV
Eudract number
2016-003737-15
Clinicaltrials.gov Identifier
17/YH/0289, REC reference
Duration of Study in the UK
2 years, 6 months, 0 days
Research summary
This is a proof-of-concept study, that means it has been designed to evaluate the safety and efficacy of an investigational drug called AZD6738, when administered alone and when administered in combination with another investigational drug called acalabrutinib (also known as ACP-196), as a possible treatment for adult patients with relapsed/refractory high-risk Chronic Lymphocytic Leukemia (CLL), that means that this type of leukemia has returned after a period of improvement, or has proved resistant, or not having responded to treatment.
The effect of both study drug(s) on the body, including how the study drug(s) are absorbed, will be evaluated. Biomarker testing will also be done to determine the effect of the study drug(s) on your cancer cells and/or to study individual genetic variations and their relationship to how a patient and their disease (tumour) respond to study drug treatment.
This study has two parts, Part 1 and Part 2.
Part 1 of the study will determine the best dose of AZD6738 and how it should be given when administered alone (often called monotherapy) and when administered in combination with acalabrutinib. The dose identified in Part 1 of the study will be used in Part 2 of this study. Part 2 is followed upon completion of Part 1.
Part 1 of the study will enrol 6 to 12 subjects.
Part 2 of the study will enrol up to 50 subjects.
The study will last 2,5 year.REC name
Yorkshire & The Humber - Leeds West Research Ethics Committee
REC reference
17/YH/0289
Date of REC Opinion
16 Oct 2017
REC opinion
Further Information Favourable Opinion