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The combination of paclitaxel and pexidartinib was studied in a Phase Ib clinical trial for patients with advanced solid tumors to evaluate its safety, tolerability, and efficacy. Patients received escalating doses of pexidartinib with weekly paclitaxel (80 mg/m²), with the recommended Phase II dose for pexidartinib determined as 1600 mg/day. The combination was generally well tolerated, with common grade 3-4 adverse events including anemia (26%), neutropenia (22%), lymphopenia (19%), fatigue (15%), and hypertension (11%). Efficacy results from evaluable patients showed a 3% complete response rate, 13% partial response rate, and 34% stable disease. The combination aims to mitigate macrophage tumor infiltration and enhance the efficacy of cytotoxic chemotherapy through CSF-1R inhibition by pexidartinib. The study also demonstrated that pexidartinib effectively blocked CSF-1R signaling.
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