Trial purpose
Cancer treatment
Tumor type
Haematological
Age
18 - 110
Clinical summary
Summary
The purpose of this study is to evaluate how safe and tolerable a targeted medicine called AZD2962 is, when given by itself and with other anti-cancer treatments.
The trial is recruiting people with myelodysplastic syndromes (MDS) and dysplastic chronic myelomonocytic leukaemia (CMML).
Module 1 of this study will comprise of:
- A screening period of maximum 21 days.
- Treatment period with 28-day cycles, where each participant will receive an oral dose of AZD2962 once daily, and will continue treatment until disease progression, unacceptable toxicity, or withdrawal.
- Safety Follow-up period after 30 days after the last dose of medication.
Conditions
This trial is treating people with relapsed or refractory dysplastic chronic myelomonocytic leukaemia (CMML) or myelodysplastic syndromes (MDS)
Eligibility
Inclusion
- Participants with relapsed/refractory MDS or participants with relapsed/refractory dysplastic CMML, with peripheral blasts or bone marrow blasts < 20%, and who received one or more prior lines of therapy as per standard of care (or who exhausted locally available treatments including treatments for actionable mutations). Diagnosis must be histologically confirmed as per the WHO 2016 classification of myeloid neoplasms.
- Eastern Cooperative Oncology Group (ECOG) performance status of ≤2.
- Participants must have symptomatic disease that requires therapy and allows for objective efficacy assessments.
- Willing to provide baseline bone marrow aspirate (or biopsy if dry-tap).
- Contraceptive use by participants or participant partners should be consistent with local regulations and also comply with Clinical Study Protocol requirements.
- All women of childbearing potential must have a negative serum pregnancy test result at Screening.
Exclusion
- Prior treatment with IRAK inhibitors or inhibitors of the inflammasome pathway.
- Received any antineoplastic therapy (except hydroxyurea) within 15 days prior to first dose.
- Received any strong or moderate Cytochrome P450 3A (CYP3A) inhibitors within 15 days prior to first dose.
- Received major surgery within 28 days prior to first dose, or still recovering from surgery.
- Received drugs that are known to prolong corrected QT interval (QTc) and with known risk of Torsades de Pointes, within 15 days prior to first dose.
- Received immunosuppressive medications (including Graft-Versus-Host Disease prophylaxis) within 28 days prior to first dose, or within 15 days in the case of systemic steroids (doses exceeding 10 mg/day of prednisone or equivalent).
- Received live attenuated vaccines within 28 days prior to first dose.
- Active major bleeding event.
- Any evidence of systemic disease, significant clinical disorder, or laboratory finding that make undesirable the participation in the study.
15. Mean resting corrected QT interval using Fridericia's formula (QTcF) > 450 ms obtained from triplicate Electrocardiograms (ECGs) and averaged, recorded within 5 minutes. In the presence of bundle branch block, QTcF > 470 ms is applicable.
16. History of intracranial bleeding within 6 months prior to first dose. 17. Active gastrointestinal disease or other condition that will interfere significantly with the absorption, distribution, metabolism or excretion of oral therapy.
18. History of a prior non-haematologic neoplasm (with some exceptions). 19. Unresolved Grade > 2 toxicities from prior anticancer therapies (with some exceptions).
20. Concurrent enrolment in another clinical study (with some exceptions). 21. Known hypersensitivity to study intervention or its excipients.
Inclusion
- You have had treatment, but your cancer has come back (relapsed or recurrent).
- You have had treatment but your cancer has gotten worse or has not responded to the treatment you have been given.
Exclusion
- You have certain types of non-cancer medical conditions.
- You have had certain treatments, surgical procedures or drugs.
Clinical trials have complex eligibility criteria, and other criteria may apply for this trial. Ask your doctor about whether this trial could be right for you.
More information
Trial Identifiers
Information on this page is partially produced from ClinicalTrials.gov, EU Clinical Trials Register *. View further details about this trial on the registry via the links below:
Trial sponsor
AstraZeneca
Scientific Title
A Modular Phase I/II, Open-label, Multicentre Study to Evaluate the Safety, Tolerability and Preliminary Efficacy of AZD2962, an IRAK4 Inhibitor, as Monotherapy and in Combination With Other Agents, in Participants With Haematologic Neoplasms
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