TAS1553-01
Research type
Research Study
Full title
A Phase 1 Study of Safety, Pharmacokinetics and Preliminary Activity of TAS1553 in Subjects with Relapsed or Refractory (R/R) Acute Myeloid Leukemia (AML) and Other Myeloid Neoplasms
IRAS ID
307603
Contact name
Steven Knapper
Contact email
Sponsor organisation
Astex Pharmaceuticals, Inc.
Eudract number
2021-003593-31
Clinicaltrials.gov Identifier
Duration of Study in the UK
0 years, 6 months, 30 days
Research summary
Astex Pharmaceuticals, Inc. (Astex) is developing TAS1553, a novel small molecule, to treat acute myeloid leukaemia (AML) and/or other cancers of the bone marrow (for example, myeloid neoplasms including myelodysplastic syndromes/myeloproliferative neoplasms (MDS/MPN) and MPN unclassifiable in any phase, and accelerated phase MPN) where approved therapies have failed or for whom known life-prolonging therapies are not yet available.
The study drug is in a class of drugs called ribonucleotide reductase (RNR) inhibitors which may block the growth of cancer cells. It may block proteins from being made properly in cancer cells and therefore prevent cancer cells from multiplying.
The study drug is being given to people for the first time in this study. People with AML or another cancer of the bone marrow who have relapsed or who have not responded to other drugs will be eligible to receive the study drug. The purpose of the study is to test the safety of the study drug, how much of the study drug is found in the body based on what dose patients get, how the study drug works on the disease, and to find the appropriate dose of this study drug to use in this and other future studies.
The study is expected to last about 24 months, and the sponsor expects to enrol about 90 participants globally at approximately 25 centres in North America and Europe.REC name
London - London Bridge Research Ethics Committee
REC reference
22/LO/0230
Date of REC Opinion
12 Apr 2022
REC opinion
Further Information Favourable Opinion