36
Participants
Start Date
September 19, 2024
Primary Completion Date
June 5, 2028
Study Completion Date
June 5, 2028
ON 123300
"dosed starting at 200 mg of ON 123300 (NARAZACICLIB) daily for four weeks. Dose levels will be 160 mg, 200 mg, 240 mg, 280 mg, 320 mg. Treatment cycles will be four weeks long.~ON 123300 (NARAZACICLIB) is available as an oral formulation ON 123300 (NARAZACICLIB) monolactate capsules (containing 40 mg free base) and is provided in 120 cc high-density polyethylene (HDPE) bottles with child-resistant closures containing 30 hard gelatin capsules. ON 123300 (NARAZACICLIB) is also available in tablet form. The tablets are 40 mm (oblong) and 120 mg (round). Either form, capsules or tablets, may be used in this study."
Dexamethasone
Weekly oral dexamethasone 20mg
RECRUITING
Mount Sinai Health System, New York
Adriana Rossi
OTHER