Ribociclib and Gemcitabine Hydrochloride in Treating Patients With Advanced or Metastatic Solid Tumors

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PRIMARY OBJECTIVES: I. To describe the dose-limiting toxicities and identify the maximum tolerated dose (MTD) and recommended phase II dose of the combination of ribociclib and gemcitabine hydrochloride (gemcitabine) in patients with advanced solid tumors. SECONDARY OBJECTIVES: I. To describe the sa...

PRIMARY OBJECTIVES: I. To describe the dose-limiting toxicities and identify the maximum tolerated dose (MTD) and recommended phase II dose of the combination of ribociclib and gemcitabine hydrochloride (gemcitabine) in patients with advanced solid tumors. SECONDARY OBJECTIVES: I. To describe the safety and tolerability of the combination of ribociclib and gemcitabine. II. To describe the pharmacokinetic (PK) of ribociclib in combination with gemcitabine. III. To describe preliminary evidence of efficacy of the combination of ribociclib and gemcitabine. TERTIARY OBJECTIVES: I. To evaluate the correlation of CDK4/6, cyclin D1 and cyclin D3 amplification, retinoblastoma (RB) and P16 expression in archived and biopsied tumor tissue with treatment response. OUTLINE: This is a dose-escalation study. Patients receive gemcitabine hydrochloride intravenously (IV) over 30 minutes on days 1 and 8 and ribociclib orally (PO) once daily (QD) on days 8-14. Courses repeat every 21 days in the absence of disease progression or unacceptable toxicity.

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