A Phase 1b, Multicenter, Open-Label, Dose Escalation Study of SAR245409 to Evaluate the Safety, Tolerability and Clinical Activity of SAR245409 in Combination With Bendamustine and/or Rituximab in Subjects With Relapsed or Refractory Indolent B-cell Non-Hodgkin Lymphoma, Mantle Cell Lymphoma or Chronic Lymphocytic Leukemia

Status
Active
Cancer Type
Non-Hodgkin Lymphoma
Trial Phase
Phase I
Eligibility
18 and over, Male and Female
Study Type
Biomarker/Laboratory analysis
Treatment
NCD ID
NCT01410513
Protocol IDs
TCD12012 (primary)
U1111-1119-2906
Study Sponsor
Sanofi-Aventis - US - Bridgewater

Summary

Primary Objective:

  • To determine the maximum tolerated dose (MTD) and recommended Phase 2 dose (RP2D) for SAR245409 when administered in combination with bendamustine and/or rituximab

Secondary Objectives:

  • To determine the safety and tolerability of SAR245409 in combination with bendamustine and/or rituximab in subjects with indolent Non-Hodgkin Lymphoma (iNHL) Mantle Cell Lymphoma (MCL) or Chronic Lymphocytic Leukemia (CLL)
  • To determine the pharmacokinetics (PK) of SAR245409, bendamustine and rituximab when used in combination in subjects with iNHL, MCL or CLL
  • To determine the pharmacodynamic (PD) effects of SAR245409 in combination with bendamustine and/or rituximab in subjects with iNHL, MCL or CLL
  • To determine the antitumor activity of SAR245409 in combination with bendamustine and/or rituximab in subjects with iNHL, MCL or CLL

Objectives

All subjects will take SAR245409 twice daily. All subjects will receive SAR245409 as long as there is clinical benefit.

Combination therapy with SAR245409 and either bendamustine or rituximab as doublet therapy, or with bendamustine and rituximab as triplet therapy, will be administered over a 28 day cycle.

Subjects receiving the doublet containing rituximab will receive rituximab for 4 - 8 weeks.

Subjects with iNHL or MCL receiving bendamustine either as a doublet or triplet therapy will receive a maximum of 8 cycles of therapy. Subjects CLL receiving bendamustine either as a doublet or triplet therapy will receive a maximum of 6 cycles of therapy.