View clinical trials related to Neoplasm Malignant.
Filter by:Primary Objective: - To assess the effect of SAR302503 (500 mg) administered as 14-day repeated doses on the QTcF interval compared to 1-day placebo in patients with advanced solid tumors. Secondary Objectives: - To assess the effect of SAR302503 administered as 14-day repeated doses on heart rate (HR), QT, QTcB, and QTcN, PR and QRS compared to placebo. - To assess the clinical and laboratory safety of SAR302503 - To document the plasma concentrations of SAR302503 at the time of ECG investigation. - To explore the Pharmacokinetic/Pharmacodynamic relationship between SAR302503 concentration and QTcF - To explore antitumor activity
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)
Primary Objective: In the dose escalation: to determine the maximum tolerated dose (MTD) of SAR125844. In the expansion cohort: to evaluate the preliminary anti-tumoral effect of SAR125844 in patients with measurable and MET gene amplification (including gastric cancer patients). Secondary Objectives: To characterize and confirm the global safety profile of SAR125844 including cumulative toxicities. To assess preliminary antitumor activity of SAR125844. To explore the pharmacodynamic effects (PDy) of SAR125844. To evaluate the pharmacokinetic profile of SAR125844. To explore the relationship of MET gene amplification status with antitumor effects. To evaluate other pharmacodynamic biomarkers.
Primary Objectives: - To determine safety and the maximum tolerated dose (MTD) of SAR405838 through the characterization of dose-limiting toxicities (DLTs). - To assess biological activities in patients with dedifferentiated liposarcoma during MTD cohort expansion. Secondary Objectives: - Pharmacokinetic (PK) profile of SAR405838. - Biomarkers in association with SAR405838. - Anti-tumor activity in response to SAR405838. - Food effect on SAR405838 PK. - Compliance with SAR405838 treatment. - Cytochrome P450 3A4/5 (CYP3A4/5) activity.
Primary Objective: - To evaluate the safety and tolerability of SAR245409 tablets administered once or twice a day in patients with solid tumors or lymphoma. Secondary Objectives: - To evaluate blood levels of SAR245409 after administration of SAR245409 tablets once or twice a day in patients with solid tumors or lymphoma. - To evaluate the effect of food on blood levels of SAR245409 after administration of SAR245409 tablets in patients with solid tumors or lymphoma. - To evaluate the effect of SAR245409 on the body after administration of SAR245409 tablets once or twice a day in patients with solid tumors or lymphoma. - To obtain information on how SAR245409 administered once or twice a day to patients with solid tumors or lymphoma affect disease symptoms and study treatment side effects as reported by the patients on a questionnaire. - To explore the antitumor activity of SAR245409 tablets administered once or twice a day to patients with solid tumors or lymphoma.
Primary Objective: The purpose of this study was to determine the long term safety and tolerability of SAR245408 and SAR245409 as a monotherapy or as part of a combination regimen in participants who were benefiting from treatment.
Primary Objective: - To assess potential impact of moderate and severe renal impairment on the pharmacokinetics of cabazitaxel Secondary Objective: - To assess the safety of cabazitaxel in patients with various degrees of renal impairment
Primary Objective: - To assess the safety and the maximum tolerated dose(MTD) of iniparib as a single agent and in combination with chemotherapeutic regimens in patients with advanced solid tumors that are refractory to standard therapy. Secondary Objectives: - To assess the antitumor effect of iniparib (per Response Evaluation Criteria in Solid Tumors [RECIST]) Version 1.1 in patients with measurable disease. - To characterize iniparib (and its metabolites, if possible) pharmacokinetics. Based on data generated by Sanofi, it is concluded that iniparib does not possess characteristics typical of the PARP inhibitor class. The exact mechanism has not yet been fully elucidated, however based on experiments on tumor cells performed in the laboratory, iniparib is a novel investigational anti-cancer agent that induces gamma-H2AX (a marker of DNA damage) in tumor cell lines, induces cell cycle arrest in the G2/M phase in tumor cell lines, and potentiates the cell cycle effects of DNA damaging modalities in tumor cell lines. Investigations into potential targets of iniparib and its metabolites are ongoing.
Primary Objective: - To confirm safety and tolerability of global recommended phase three dose (RPTD) of SAR245408 tablets when administered on continuous once daily dosing (CDD) in patients with solid tumors. Secondary Objectives: - To evaluate the plasma pharmacokinetics (PK) of daily oral administration of SAR245408 in CDD treatment schedule in patients with solid tumors. - To gather preliminary efficacy data after repeated administration of SAR245408 in patients with solid tumors.
Primary Objective: To determine the maximum tolerated dose (MTD) of SAR566658 Secondary Objectives: - To characterize the safety profile of SAR566658 - To evaluate the pharmacokinetic profile of SAR566658 - To assess the potential immunogenicity of SAR566658 - To assess preliminary antitumor activity - To assess the effect of SAR566658 at recommended dose on CYP3A enzyme activity using midazolam - To assess safety in the alternative schedules of SAR566658 administration