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

• Status: Completed
• Trial end date: 2015-02-01

Summary

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)

• Phase: Phase 1

Details

• Lead Sponsor: Sanofi
• Treatments: Vemurafenib