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Brief Title: A Dose Escalation Study to Investigate the Safety, Pharmacokinetics (PK), Pharmacodynamics (PD) and Clinical Activity of GSK525762 in Subjects With Relapsed, Refractory Hematologic Malignancies
Official Title: 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
Study ID: NCT01943851
Brief Summary: 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 (QD) 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 select relapsed refractory hematological malignancies (acute myeloid leukemia \[AML\], non-Hodgkin's Lymphoma \[NHL\]and multiple myeloma \[MM\]), will be enrolled in the QD and/or BID dosing cohorts until a MTD is established. Subjects may continue treatment in the study until disease progression, unacceptable toxicity, or withdrawal of consent. . Upon determination of the MTD, twice daily (BID) dosing cohorts may be opened to collect additional safety data and evaluate the preliminary efficacy of GSK525762 administered BID. Part 2 will explore clinical activity at the MTD or RP2D; separate expansion cohorts will be planned for acute myeloid leukemia (AML), non-Hodgkin's Lymphoma (NHL, including an exploratory sub-cohort of subjects with myc and B-Cell Leukemia (BCL)2 and/or BCL6 rearrangements/overexpression \[double- and triple-hit lymphoma\]), and multiple myeloma (MM). 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.
Detailed Description:
Minimum Age: 18 Years
Eligible Ages: ADULT, OLDER_ADULT
Sex: ALL
Healthy Volunteers: No
GSK Investigational Site, Little Rock, Arkansas, United States
GSK Investigational Site, Aurora, Colorado, United States
GSK Investigational Site, New York, New York, United States
GSK Investigational Site, Philadelphia, Pennsylvania, United States
GSK Investigational Site, Houston, Texas, United States
GSK Investigational Site, East Melbourne, Victoria, Australia
GSK Investigational Site, Seoul, , Korea, Republic of
GSK Investigational Site, Seoul, , Korea, Republic of
GSK Investigational Site, Barcelona, , Spain
GSK Investigational Site, Madrid, , Spain
GSK Investigational Site, Madrid, , Spain
GSK Investigational Site, Málaga, , Spain
GSK Investigational Site, Salamanca, , Spain
GSK Investigational Site, Cambridge, , United Kingdom
GSK Investigational Site, London, , United Kingdom
Name: GSK Clinical Trials
Affiliation: GlaxoSmithKline
Role: STUDY_DIRECTOR