Calendario›SNY›SAR260301
SAR260301
A Phase I/Ib Trial for the Evaluation of SAR260301 in Monotherapy or in Combination With Vemurafenib in Patients With Various Advanced Cancer
Ensayo de Sanofi en Neoplasm Malignant (del registro, en inglés).
- Fase
- Fase 1
- Estado
- Completado
- Participantes
- 75
- Centros
- 4
- Fin del objetivo primario
- feb 2015
previstos
fecha real
Qué significa cada fase y cada estado.
Estudio de intervención, no aleatorizado, abierto. Comenzó en ago 2012.
Qué mide
Maximal tolerated dose (MTD) of SAR260301 in monotherapy (Study Part A) (del registro, en inglés) (dia 28)
Cómo lo describe el promotor
En el documentoEn inglés, del registroPrimary 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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Todos los de SNY, en su ficha.
Ficha completa en ClinicalTrials.gov (NCT01673737), actualizada en abr 2015.