A Phase 2 Study of SAR245409 in Patients With Relapsed or Refractory Mantle Cell Lymphoma, Follicular Lymphoma, or Chronic Lymphocytic Leukemia/Small Lymphocytic Lymphoma

Status
Active
Cancer Type
Leukemia
Trial Phase
Phase II
Eligibility
18 and over, Male and Female
Study Type
Biomarker/Laboratory analysis
Treatment
NCD ID
NCT01403636
Protocol IDs
ARD12130 (primary)
2011-001616-57
U1111-1118-6417
Study Sponsor
Sanofi-Aventis - US - Bridgewater

Summary

Primary Objective:

  • To evaluate the efficacy of SAR245409 as determined by the objective response rate (ORR) in patients with 1 of following relapsed or refractory lymphoma or leukemia subtypes: mantle cell lymphoma (MCL), follicular lymphoma (FL), or chronic lymphocytic leukemia (CLL)/small lymphocytic lymphoma (SLL)

Secondary Objectives:

  • To assess duration of response, progression free survival (PFS), and proportion of patients with PFS at 6 months (24 weeks) in patients with either MCL, FL, or CLL/SLL treated with SAR245409
  • To evaluate the safety and tolerability of SAR245409 in patients with MCL, FL, or CLL/SLL
  • To further characterize the plasma pharmacokinetics (PK) of SAR245409 in patients with MCL, FL, or CLL/SLL

Objectives

There is a 28 day screening period followed by 28 day cycles. Patients will continue to receive SAR245409 as long as there is clinical benefit or until a study withdrawal criterion is met. The last posttreatment visit will be 30 days after the last dose or until Investigational Medicinal Product-related toxicities have resolved or are deemed irreversible, whichever is later.