Phase
Condition
Neoplasms
Hematologic Neoplasms
Treatment
AZD2962
Clinical Study ID
Ages 18-110 All Genders
Study Summary
Eligibility Criteria
Inclusion
Key Inclusion Criteria:
Participants with relapsed/refractory MDS or participants with relapsed/refractorydysplastic CMML, with peripheral blasts or bone marrow blasts < 20%, and whoreceived one or more prior lines of therapy as per standard of care (or whoexhausted locally available treatments including treatments for actionablemutations). Diagnosis must be histologically confirmed as per the WHO 2016classification of myeloid neoplasms.
Eastern Cooperative Oncology Group (ECOG) performance status of ≤2.
Participants must have symptomatic disease that requires therapy and allows forobjective efficacy assessments.
Willing to provide baseline bone marrow aspirate (or biopsy if dry-tap).
Contraceptive use by participants or participant partners should be consistent withlocal regulations and also comply with Clinical Study Protocol requirements.
All women of childbearing potential must have a negative serum pregnancy test resultat Screening.
Exclusion
Key Exclusion Criteria:
Prior treatment with IRAK inhibitors or inhibitors of the inflammasome pathway.
Received any antineoplastic therapy (except hydroxyurea) within 15 days prior tofirst dose.
Received any strong or moderate Cytochrome P450 3A (CYP3A) inhibitors within 15 daysprior to first dose.
Received major surgery within 28 days prior to first dose, or still recovering fromsurgery.
Received drugs that are known to prolong corrected QT interval (QTc) and with knownrisk of Torsades de Pointes, within 15 days prior to first dose.
Received immunosuppressive medications (including Graft-Versus-Host Diseaseprophylaxis) within 28 days prior to first dose, or within 15 days in the case ofsystemic 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 laboratoryfinding that make undesirable the participation in the study.
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.
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.
History of a prior non-haematologic neoplasm (with some exceptions). 19. Unresolved Grade > 2 toxicities from prior anticancer therapies (with some exceptions).
Concurrent enrolment in another clinical study (with some exceptions). 21. Known hypersensitivity to study intervention or its excipients.
Study Design
Study Description
Connect with a study center
Research Site
Heidelberg, 3084
AustraliaSite Not Available
Research Site
Heidelberg 2163654, 3084
AustraliaActive - Recruiting
Research Site
Melbourne, 3000
AustraliaSite Not Available
Research Site
Melbourne 2158177, 3000
AustraliaActive - Recruiting
Research Site
Shinagawa-ku, 141-0022
JapanActive - Recruiting
Research Site
Yoshida-gun, 910-1193
JapanActive - Recruiting
Research Site
Seoul, 05505
Korea, Republic ofSite Not Available
Research Site
Seoul 1835848, 05505
South KoreaSite Not Available
Research Site
Barcelona, 08035
SpainSite Not Available
Research Site
Barcelona 3128760, 08035
SpainActive - Recruiting
Research Site
Madrid, 28033
SpainSite Not Available
Research Site
Madrid 3117735, 28027
SpainActive - Recruiting
Research Site
Pamplona, 31008
SpainSite Not Available
Research Site
Pamplona 3114472, 31008
SpainActive - Recruiting
Research Site
Salamanca, 37007
SpainSite Not Available
Research Site
Salamanca 3111108, 37007
SpainActive - Recruiting
Research Site
Valencia, 46026
SpainSite Not Available
Research Site
Valencia 2509954, 46026
SpainSite Not Available
Research Site
Kaohsiung, 83301
TaiwanSite Not Available
Research Site
Kaohsiung City 1673820, 83301
TaiwanSite Not Available
Research Site
Tainan 1668355, 70403
TaiwanSite Not Available
Research Site
Taipei, 10002
TaiwanSite Not Available
Research Site
Taipei 1668341, 100
TaiwanActive - Recruiting
Research Site
London, NW1 2PG
United KingdomSite Not Available
Research Site
London 2643743, W1T 7HA
United KingdomActive - Recruiting
Research Site
Manchester, M20 4BX
United KingdomSite Not Available
Research Site
Manchester 2643123, M20 4BX
United KingdomActive - Recruiting
Research Site
Tampa, Florida 33612
United StatesSite Not Available
Research Site
Miami 4164138, Florida 4155751 33136
United StatesSite Not Available
Research Site
Tampa 4174757, Florida 4155751 33612
United StatesActive - Recruiting
Research Site
Houston 4699066, Texas 4736286 77030
United StatesActive - Recruiting

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