ASTX660 in Subjects with Advanced Solid Tumors and Lymphomas
Research type
Research Study
Full title
Phase 1-2 Study of the Safety, Pharmacokinetics, and Preliminary Activity of ASTX660 in Subjects with Advanced Solid Tumors and Lymphomas
IRAS ID
235251
Contact name
Dima El-Sharkawi
Contact email
Sponsor organisation
Astex Pharmaceuticals, Inc.
Eudract number
2016-005039-34
Clinicaltrials.gov Identifier
Duration of Study in the UK
2 years, 0 months, 14 days
Research summary
This is an open-label phase 1/2 study of an experimental drug called ASTX660. The purpose of the study is to evaluate the safety and activity of ASTX660 in patients with solid tumors and blood cancers. Open label means that both the patient and the study doctor know which treatment the patient will be receiving in this study (ie, ASTX660).
The phase 1 part of the study is now completed. The phase 2 part of the study will assess the preliminary clinical activity of ASTX660, as determined by response rate, in certain tumor types.
Patients will receive ASTX660 once a day for 7 consecutive days every other week of each 28 day cycle (ie, daily dosing on Days 1 -7 and 15-21). The route of administration is by mouth.
The study will be conducted in Europe and North America with a total of approximately 230 evaluable subjects (Phase 1 and Phase 2).
The overall study duration (Phase 1 and Phase 2) is expected to be about 66 months. The amount of time patients will be on study treatment depends on how they respond to the study treatment.REC name
East Midlands - Nottingham 2 Research Ethics Committee
REC reference
17/EM/0444
Date of REC Opinion
31 Jan 2018
REC opinion
Further Information Favourable Opinion