A Phase I/II Open-Label, Dose Escalation Study to Investigate the Safety, Pharmacokinetics, Pharmacodynamics, and Clinical Activity of GSK525762 in Subjects with NUT Midline Carcinoma (NMC) and Other Cancers (BET115521)
Johns Hopkins Kimmel Cancer Center in Baltimore
This research is being done to test the safety and effectiveness of the study drug GSK525762 for NUT midline carcinoma (NMC) and other cancers. This study will look at how people react to and how the body uses GSK525762 at different doses.
Adults (18 or above) with confirmed, measureable advanced solid tumors (NUT Midline Carcinoma (NMC) and Other Cancers). Discontinuation of prior cancer treatment within a minimum of 2 weeks of taking study drugs (including radiotherapy, targeted therapy, immunotherapy, and hormonal therapy; 28 days for major surgery). Participants must have adequate performance status and blood counts (white cells, platelets, ANC) as well as kidney and liver function. No prior malignancies of the central nervous system, malignancies related to HIV or solid organ transplant. No symptomatic or untreated brain metastases or spinal cord compression. No significant cardiac abnormalities. Current use of anticoagulants (e.g., warfarin, heparin) at therapeutic levels within 7 days prior to the first dose of GSK525762.
Each dosing cycle consists of 28 days (4, 7 day periods). During week 1 participants will take GSK525762 by mouth on days 1, 3, 4 and 5. Week 2 dosing occurs on days 1,2,3,4,5. During weeks 3 and 4 patients dose every day (days 1-7). Blood tests will be done frequently to ensure adequate blood counts. Regular cardiac monitoring will also be necessary to monitor for any potential cardiac issues.
06/25/2016 05:03 AM