Use the hyperlinks, where available to access additional clinical trial information.
A Phase I/II Open-label, Dose Escalation Study to Investigate the Safety, Pharmacokinetics, Pharmacodynamics and Clinical Activity of GSK525762 in Subjects With Relapsed, Refractory Hematologic Malignancies
This is an open-label repeat dose, multicenter, 2-part study to determine the maximum tolerated dose (MTD) and the recommended Phase 2 dose (RP2D) for GSK525762 given once-daily orally. Part 1 of the study is a dose escalation phase to select the recommended Part 2 dose (RP2D) based on the safety, PK, and PD profiles observed after oral administration of GSK525762. Eligible subjects with relapsed refractory hematological malignancies will be enrolled in the dosing cohorts until a MTD is established. Subjects may continue treatment in the study until disease progression, unacceptable toxicity, withdrawal of consent, or commercial supply of GSK525762 becomes available to the subject. An expansion cohort (Part 2) is planned in subjects with acute leukemias to further explore clinical activity at the MTD. This is the first study of this agent to be conducted in subjects with these relapsed and/or refractory hematological malignancies for which no standard therapies are anticipated to result in a durable remission.