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A Phase I/Ib Trial for the Evaluation of SAR260301 in Monotherapy or in Combination With Vemurafenib in Patients With Various Advanced Cancer

Sanofi · 2012
ClinicalTrials.gov · Datasets · License: Public Domain · 2012
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Primary Objective: Part A - Monotherapy: \- To determine the maximum tolerated dose (MTD) of SAR260301 administered as monotherapy and either on a once or twice daily schedule, to patients with advanced solid tumors or lymphomas. Part B - Combination: \- To determine the maximum tolerated dose (MTD) of SAR260301 administered in combination with the recommended standard dosage of vemurafenib to patients with unresectable / metastatic v-raf murine sarcoma viral oncogene homolog B1 (BRAF)-mutated melanoma. Secondary Objectives: * To characterize the overall safety and tolerability profile of SAR260301 administered as monotherapy (Part A) and in combination with vemurafenib (Part B). * To characterize the pharmacokinetic (PK) profile of SAR260301 administered as monotherapy (Part A) and in combination with vemurafenib (Part B) as well as vemurafenib PK in combination with SAR260301 (Part B) * To evaluate food effect on SAR260301 PK (Part A) * To assess preliminary antitumor activity according to Response Evaluation Criteria in Solid Tumors (RECIST 1.1 criteria). * To assess preliminary antitumor activity using volumetric computed tomography (CT) or magnetic resonance imaging(MRI) * To evaluate the pharmacodynamic (PD) effects of SAR260301 on blood and tumor. * To evaluate PK/PD relationships. * To identify the recommended phase 2 dose of SAR260301 in combination with vemurafenib (RP2D) (Part B only) * To assess potential induction effect of SAR260301 on cytochrome P450 (CYP) isoenzyme 3A (CYP3A) (Part A)
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