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A combination therapy consisting of gemcitabine, a nucleoside analog chemotherapy agent, and milciclib, an orally bioavailable inhibitor of multiple cyclin-dependent kinases (CDKs) and tropomyosin receptor kinase A (TRKA). This combination has shown encouraging clinical benefit in patients with refractory solid tumors, including gemcitabine-refractory patients. The recommended Phase II dose is 80 mg/m²/day for milciclib and 1000 mg/m²/day for gemcitabine, with milciclib administered orally once daily for 7 days on/7 days off in a 4-week cycle, and gemcitabine administered intravenously on days 1, 8, and 15 in a 4-week cycle.
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