Clinical Trials Directory

Trials / Completed

CompletedNCT01410513

Study Combining SAR245409 With Rituximab or Bendamustine Plus Rituximab in Patients With Indolent Lymphoma, Mantle Cell Lymphoma and Chronic Lymphocytic Leukemia

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

Status
Completed
Phase
Phase 1
Study type
Interventional
Enrollment
37 (actual)
Sponsor
Sanofi · Industry
Sex
All
Age
18 Years
Healthy volunteers
Not accepted

Summary

Primary Objective: \- To determine the maximum tolerated dose (MTD) and recommended Phase 2 dose (RP2D) for SAR245409 when administered in combination with rituximab or bendamustine plus rituximab Secondary Objectives: * To determine the safety and tolerability of SAR245409 in combination with rituximab or bendamustine plus rituximab in subjects with indolent Hon-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 rituximab or bendamustine plus rituximab in subjects with iNHL, MCL or CLL * To determine the antitumor activity of SAR245409 in combination with rituximab or bendamustine plus rituximab in subjects with iNHL, MCL or CLL

Detailed description

All subjects will take SAR245409 twice daily. All subjects will receive SAR245409 as long as there is clinical benefit. Combination therapy with SAR245409, bendamustine and rituximab , will be administered over a 28 day cycle for up to 6 to 8 cycles. Subjects receiving the doublet combination , SAR245409 plus rituximab will receive weekly rituximab for 4 - 8 weeks. Monthly Rituximab may be continued beyond 8 weeks.

Conditions

Interventions

TypeNameDescription
DRUGSAR245409Pharmaceutical form:capsule Route of administration: oral

Timeline

Start date
2011-12-01
Primary completion
2014-05-01
Completion
2014-05-01
First posted
2011-08-05
Last updated
2016-04-01

Locations

3 sites across 1 country: United States

Source: ClinicalTrials.gov record NCT01410513. Inclusion in this directory is not an endorsement.