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

Status

Indicates the current recruitment status or the expanded access status.
Completed

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

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

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
167

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • 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

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

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

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
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

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
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

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
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

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
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

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
October 1, 2011

Primary Completion (ACTUAL)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
September 1, 2014

Study Completion (ACTUAL)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
September 1, 2014

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
July 26, 2011

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
July 26, 2011

First Posted (ESTIMATE)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
July 27, 2011

Study Record Updates

Last Update Posted (ESTIMATE)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
March 17, 2016

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
February 17, 2016

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
February 1, 2016

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant 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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