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

February 17, 2016 updated by: Sanofi

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

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

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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 Type

Interventional

Enrollment (Actual)

167

Phase

  • Phase 2

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Australia
      • Clayton, Australia, 3168
        • Investigational Site Number 036002
      • Hobart, Australia, 7001
        • Investigational Site Number 036001
      • Kingswood, Australia, 2747
        • Investigational Site Number 036005
      • Perth, Australia, 6000
        • Investigational Site Number 036003
  • Belgium
      • Bruxelles, Belgium, 1000
        • Investigational Site Number 056003
      • Gent, Belgium, 9000
        • Investigational Site Number 056002
      • Leuven, Belgium, 3000
        • Investigational Site Number 056001
  • France
      • Montpellier, France, 34295
        • Investigational Site Number 250002
      • Pierre Benite Cedex, France, 69495
        • Investigational Site Number 250001
      • Rennes, France, 35033
        • Investigational Site Number 250004
      • Rouen Cedex, France, 76038
        • Investigational Site Number 250005
      • Villejuif Cedex, France, 94805
        • Investigational Site Number 250003
  • Germany
      • Frankfurt Am Main, Germany, 60590
        • Investigational Site Number 276003
      • Jena, Germany, 07747
        • Investigational Site Number 276002
      • Ulm, Germany, 89081
        • Investigational Site Number 276001
  • Netherlands
      • Amsterdam, Netherlands, 1105 AZ
        • Investigational Site Number 528001
      • Groningen, Netherlands, 9713 GZ
        • Investigational Site Number 528003
      • Rotterdam, Netherlands, 3075 EA
        • Investigational Site Number 528002
  • United States
    • California
      • Los Angeles, California, United States, 90033
        • Investigational Site Number 840012
    • Florida
      • Fort Meyers, Florida, United States, 33919
        • Investigational Site Number 840104
    • Georgia
      • Augusta, Georgia, United States, 30912
        • Investigational Site Number 840006
    • Illinois
      • Maywood, Illinois, United States, 60153
        • Investigational Site Number 840011
    • Kansas
      • Kansas City, Kansas, United States, 66160-7321
        • Investigational Site Number 840010
    • Kentucky
      • Lexington, Kentucky, United States, 40536
        • Investigational Site Number 840013
      • Paducah, Kentucky, United States, 42002
        • Investigational Site Number 840007
    • Massachusetts
      • Boston, Massachusetts, United States, 02115
        • Investigational Site Number 840004
    • Missouri
      • St Louis, Missouri, United States, 63110
        • Investigational Site Number 840015
    • Ohio
      • Canton, Ohio, United States, 44718
        • Investigational Site Number 840014
    • Pennsylvania
      • Philadelphia, Pennsylvania, United States, 19111
        • Investigational Site Number 840001
    • West Virginia
      • Morgantown, West Virginia, United States, 26506
        • Investigational Site Number 840002

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (ADULT, OLDER_ADULT)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion criteria:

  • Tissue from an archived or fresh tumor sample
  • A peripheral blood buffy coat sample is required for CLL/SLL.
  • Patient has mantle cell lymphoma (MCL), follicular lymphoma (FL), or chronic lymphocytic leukemia (CLL)/SLL or diffuse large B cell lymphoma
  • Patient > or = 18 years old
  • Eastern Cooperative Oncology Group (ECOG) performance status < or = 2. Patients with DLBCL will have ECOG < or = 1
  • Adequate white blood cells and hemoglobin
  • Good kidney and liver function
  • Fasting glucose < 160 mg/dL
  • No other malignancy
  • Use of adequate birth control

Exclusion criteria:

  • Treatment with cytotoxic chemotherapy, biologic agents, investigational therapies within 4 weeks, or nitrosoureas or mitomycin C within 6 weeks of study enrollment
  • Treatment with a small-molecule kinase inhibitor within 2 weeks, or 5 half lives of the drug or its active metabolites (whichever is longer) of study enrollment
  • Prior treatment with a PI3K, mTOR, or Akt inhibitor. Prior treatment of MCL with temsirolimus is permitted in patients enrolled from countries where it is licensed for this indication.
  • Radiation therapy within 2 weeks of enrollment
  • Autologous stem cell transplantation within 16 weeks of enrollment
  • Prior allogeneic transplantation except for patients with R/R DLBCL who meet inclusion criteria
  • Central nervous system (CNS) or leptomeningeal involvement. Patients with DLBCL may have active CNS or leptomeningeal involvement.
  • Positive Hepatitis B surface antigen (HBsAg) or Hepatitis C antibody (anti-HCV) serology
  • Primary CNS lymphoma
  • Primary mediastinal B-lymphoma

The above information is not intended to contain all considerations relevant to a patient's potential participation in a clinical trial.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: TREATMENT
  • Allocation: NON_RANDOMIZED
  • Interventional Model: PARALLEL
  • Masking: NONE

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
EXPERIMENTAL: mantle cell
50 mg twice daily: no eating for 2 hours prior and 1 hour after dose
Drug: SAR245409
Pharmaceutical form:capsule Route of administration: oral
EXPERIMENTAL: follicular lymphoma
50 mg twice daily: no eating for 2 hours prior and 1 hour after dose
Drug: SAR245409
Pharmaceutical form:capsule Route of administration: oral
EXPERIMENTAL: CLL/SLL
50 mg twice daily:no eating for 2 hours prior and 1 hour after dose
Drug: SAR245409
Pharmaceutical form:capsule Route of administration: oral
EXPERIMENTAL: Diffuse large B cell lymphoma
50 mg twice daily:no eating for 2 hours prior and 1 hour after dose
Drug: SAR245409
Pharmaceutical form:capsule Route of administration: oral

What is the study measuring?

Primary Outcome Measures

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

Secondary Outcome Measures

Outcome Measure
Time Frame
Progression free survival (PFS) at 6 months
Time Frame: 6 months to 2 years
6 months to 2 years

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sanofi

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

October 1, 2011

Primary Completion (ACTUAL)

September 1, 2014

Study Completion (ACTUAL)

September 1, 2014

Study Registration Dates

First Submitted

July 26, 2011

First Submitted That Met QC Criteria

July 26, 2011

First Posted (ESTIMATE)

July 27, 2011

Study Record Updates

Last Update Posted (ESTIMATE)

March 17, 2016

Last Update Submitted That Met QC Criteria

February 17, 2016

Last Verified

February 1, 2016

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • ARD12130
  • 2011-001616-57 (EUDRACT_NUMBER)
  • U1111-1118-6417 (OTHER: UTN)

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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