Clinical Trials/NCT01410513

NCT01410513

Completed

Phase 1

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

Sanofi3 sites in 1 country37 target enrollmentDecember 2011

ConditionsIndolent Non-Hodgkin Lymphoma Mantle Cell Lymphoma Chronic Lymphocytic Leukemia

InterventionsSAR245409

DrugsSAR245409

Overview

Phase: Phase 1
Intervention: SAR245409
Conditions: Indolent Non-Hodgkin Lymphoma
Sponsor: Sanofi
Enrollment: 37
Locations: 3
Primary Endpoint: Identification Of Dose-Limiting Toxicity (DLT) and Maximum Tolerated Dose (MTD)
Status: Completed
Last Updated: 10 years ago

Overview Investigators Eligibility Criteria Arms & Interventions Outcomes Sites Similar Trials

Overview

Brief 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.

Registry

clinicaltrials.gov

Start Date

December 2011

End Date

May 2014

Last Updated

10 years ago

Study Type

Interventional

Study Design

Parallel

Sex

All

Investigators

Sponsor

Sanofi

Responsible Party

Sponsor

Eligibility Criteria

Inclusion Criteria

Not provided

Exclusion Criteria

Not provided

Arms & Interventions

SAR245409 + rituximab

Subjects will receive oral SAR245409 twice daily continuously and weekly rituximab intravenously

Intervention: SAR245409

SAR245409 + rituximab + bendamustine (iNHL, MCL)

Subjects will receive oral SAR245409 twice daily continuously and monthly bendamustine intravenously.

Intervention: SAR245409

SAR245409 + rituximab+ bendamustine (CLL)

Subjects will receive oral SAR245409 twice daily continuously and monthly bendamustine and rituximab intravenously

Intervention: SAR245409

Outcomes

Primary Outcomes

Identification Of Dose-Limiting Toxicity (DLT) and Maximum Tolerated Dose (MTD)

Time Frame: 4 weeks to 8 weeks

Secondary Outcomes

Pharmacokinetics (tmax) of bendamustine(up to 2 months)
Pharmacokinetics (tmax) of rituximab(up to 2 months)
Number of subjects with treatment emergent adverse events(Time from receiving first dose of SAR245409 until 30 days after the last dose)
Pharmacokinetics (tmax) of SAR245409(up to 2 months)
Pharmacokinetics (Ctrough) of SAR245409(up to 2 months)
Pharmacokinetics (AUC) of bendamustine(up to 2 months)
Pharmacokinetics (AUClast) of bendamustine(up to 2 months)
Pharmacokinetics (Ceoi) of bendamustine(up to 2 months)
Pharmacokinetics (AUC0-12h) of SAR245409(up to 2 months)
Pharmacokinetics (Cmax) of SAR245409(up to 2 months)
Pharmacokinetics (Vss) of bendamustine(up to 2 months)
Efficacy as determined by objective response rate (ORR)(up to 4 years)
Pharmacokinetics (Cl) of bendamustine(up to 2 months)
Pharmacokinetics (AUC0-7h) of rituximab(up to 2 months)
Pharmacokinetics (Ceoi) of rituximab(up to 2 months)