Neoplasm Malignant Clinical Trial
Official title:
A Phase I/Ib Study for the Evaluation of SAR260301, Administered Orally in Monotherapy in Patients With Advanced Solid Tumors or Lymphomas, and in Combination With Vemurafenib in Patients With Unresectable / Metastatic BRAF-mutated Melanoma
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)
Study duration for one patient will include a period for inclusion (screening period) of up to 4 weeks, a treatment period of at least 4 weeks, and a end-of-study visit at 30 days following the last administration of study drug. The patient may continue treatment until disease progression, unacceptable toxicity or willingness to stop, followed by a minimum of 30-days follow-up. ;
Allocation: Non-Randomized, Endpoint Classification: Safety Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment
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