A Study of Investigational SAR245409 in Patients With Certain Lymphoma or Leukemia

Phase 2

Completed

• Conditions: Lymphoma
• Interventions: Drug: SAR245409

• Registration Number: NCT01403636
• Lead Sponsor: Sanofi

Brief 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), chronic lymphocytic leukemia (CLL)/small lymphocytic lymphoma (SLL), or diffuse large B cell lymphoma (DLBCL)

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, CLL/SLL or DLBCL treated with SAR245409

* To evaluate the safety and tolerability of SAR245409 in patients with MCL, FL, CLL/SLL or DLBCL

* To further characterize the plasma pharmacokinetics (PK) of SAR245409 in patients with MCL, FL, CLL/SLL or DLBCL

Detailed Description

There is a 21 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 IMP-related toxicities have resolved or are deemed irreversible, whichever is later.

Study Timeline

• Study First Submitted: 2011-07-26
• Study First Submitted QC: 2011-07-26
• Study First Posted: 2011-07-27
• Study Start: 2011-10
• Primary Completion: 2014-09
• Study Completion: 2014-09
• Status Verified: 2016-02
• Disposition First Submitted: 2016-02-17
• Disposition First Submitted QC: 2016-02-17
• Last Update Submitted: 2016-02-17
• Disposition First Posted: 2016-03-17
• Last Update Posted: 2016-03-17

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 167

Inclusion Criteria

Not provided

Exclusion Criteria

Not provided

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
mantle cell	SAR245409	50 mg twice daily: no eating for 2 hours prior and 1 hour after dose
follicular lymphoma	SAR245409	50 mg twice daily: no eating for 2 hours prior and 1 hour after dose
Diffuse large B cell lymphoma	SAR245409	50 mg twice daily:no eating for 2 hours prior and 1 hour after dose
CLL/SLL	SAR245409	50 mg twice daily:no eating for 2 hours prior and 1 hour after dose

Primary Outcome Measures

Name	Time	Method
Objective response rate (ORR) as defined as the proportion of patients who experience complete response/remission (CR) or partial response/remission (PR)	2 months to 2 years

Secondary Outcome Measures

Name	Time	Method
Progression free survival (PFS) at 6 months	6 months to 2 years

Trial Locations

Locations (30)

Investigational Site Number 056003; 🇧🇪 Bruxelles, Belgium

Investigational Site Number 840001; 🇺🇸 Philadelphia, Pennsylvania, United States

Investigational Site Number 840002; 🇺🇸 Morgantown, West Virginia, United States

Investigational Site Number 528002; 🇳🇱 Rotterdam, Netherlands

Investigational Site Number 250002; 🇫🇷 Montpellier, France

Investigational Site Number 056002; 🇧🇪 Gent, Belgium

Investigational Site Number 840006; 🇺🇸 Augusta, Georgia, United States

Investigational Site Number 840011; 🇺🇸 Maywood, Illinois, United States

Investigational Site Number 250004; 🇫🇷 Rennes, France

Investigational Site Number 250005; 🇫🇷 Rouen Cedex, France

Investigational Site Number 056001; 🇧🇪 Leuven, Belgium

Investigational Site Number 840007; 🇺🇸 Paducah, Kentucky, United States

Investigational Site Number 840013; 🇺🇸 Lexington, Kentucky, United States

Investigational Site Number 276002; 🇩🇪 Jena, Germany

Investigational Site Number 276001; 🇩🇪 Ulm, Germany

Investigational Site Number 250001; 🇫🇷 Pierre Benite Cedex, France

Investigational Site Number 276003; 🇩🇪 Frankfurt Am Main, Germany

Investigational Site Number 840014; 🇺🇸 Canton, Ohio, United States

Investigational Site Number 840012; 🇺🇸 Los Angeles, California, United States

Investigational Site Number 840104; 🇺🇸 Fort Meyers, Florida, United States

Investigational Site Number 528001; 🇳🇱 Amsterdam, Netherlands

Investigational Site Number 528003; 🇳🇱 Groningen, Netherlands

Investigational Site Number 036002; 🇦🇺 Clayton, Australia

Investigational Site Number 036001; 🇦🇺 Hobart, Australia

Investigational Site Number 840015; 🇺🇸 St Louis, Missouri, United States

Investigational Site Number 036003; 🇦🇺 Perth, Australia

Investigational Site Number 036005; 🇦🇺 Kingswood, Australia

Investigational Site Number 250003; 🇫🇷 Villejuif Cedex, France

Investigational Site Number 840004; 🇺🇸 Boston, Massachusetts, United States

Investigational Site Number 840010; 🇺🇸 Kansas City, Kansas, United States