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

Primary Purpose

Lymphoma

Status
Completed
Phase
Phase 2
Locations
International
Study Type
Interventional
Intervention
SAR245409
Sponsored by
Sanofi
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Lymphoma

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

  • Investigational Site Number 840012
  • Investigational Site Number 840104
  • Investigational Site Number 840006
  • Investigational Site Number 840011
  • Investigational Site Number 840010
  • Investigational Site Number 840013
  • Investigational Site Number 840007
  • Investigational Site Number 840004
  • Investigational Site Number 840015
  • Investigational Site Number 840014
  • Investigational Site Number 840001
  • Investigational Site Number 840002
  • Investigational Site Number 036002
  • Investigational Site Number 036001
  • Investigational Site Number 036005
  • Investigational Site Number 036003
  • Investigational Site Number 056003
  • Investigational Site Number 056002
  • Investigational Site Number 056001
  • Investigational Site Number 250002
  • Investigational Site Number 250001
  • Investigational Site Number 250004
  • Investigational Site Number 250005
  • Investigational Site Number 250003
  • Investigational Site Number 276003
  • Investigational Site Number 276002
  • Investigational Site Number 276001
  • Investigational Site Number 528001
  • Investigational Site Number 528003
  • Investigational Site Number 528002

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm 4

Arm Type

Experimental

Experimental

Experimental

Experimental

Arm Label

mantle cell

follicular lymphoma

CLL/SLL

Diffuse large B cell lymphoma

Arm Description

50 mg twice daily: no eating for 2 hours prior and 1 hour after dose

50 mg twice daily: no eating for 2 hours prior and 1 hour after dose

50 mg twice daily:no eating for 2 hours prior and 1 hour after dose

50 mg twice daily:no eating for 2 hours prior and 1 hour after dose

Outcomes

Primary Outcome Measures

Objective response rate (ORR) as defined as the proportion of patients who experience complete response/remission (CR) or partial response/remission (PR)

Secondary Outcome Measures

Progression free survival (PFS) at 6 months

Full Information

First Posted
July 26, 2011
Last Updated
February 17, 2016
Sponsor
Sanofi
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1. Study Identification

Unique Protocol Identification Number
NCT01403636
Brief Title
A Study of Investigational SAR245409 in Patients With Certain Lymphoma or Leukemia
Official Title
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
Study Type
Interventional

2. Study Status

Record Verification Date
February 2016
Overall Recruitment Status
Completed
Study Start Date
October 2011 (undefined)
Primary Completion Date
September 2014 (Actual)
Study Completion Date
September 2014 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Sanofi

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Lymphoma

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Non-Randomized
Enrollment
167 (Actual)

8. Arms, Groups, and Interventions

Arm Title
mantle cell
Arm Type
Experimental
Arm Description
50 mg twice daily: no eating for 2 hours prior and 1 hour after dose
Arm Title
follicular lymphoma
Arm Type
Experimental
Arm Description
50 mg twice daily: no eating for 2 hours prior and 1 hour after dose
Arm Title
CLL/SLL
Arm Type
Experimental
Arm Description
50 mg twice daily:no eating for 2 hours prior and 1 hour after dose
Arm Title
Diffuse large B cell lymphoma
Arm Type
Experimental
Arm Description
50 mg twice daily:no eating for 2 hours prior and 1 hour after dose
Intervention Type
Drug
Intervention Name(s)
SAR245409
Intervention Description
Pharmaceutical form:capsule Route of administration: oral
Primary Outcome Measure Information:
Title
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
Secondary Outcome Measure Information:
Title
Progression free survival (PFS) at 6 months
Time Frame
6 months to 2 years

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Clinical Sciences & Operations
Organizational Affiliation
Sanofi
Official's Role
Study Director
Facility Information:
Facility Name
Investigational Site Number 840012
City
Los Angeles
State/Province
California
ZIP/Postal Code
90033
Country
United States
Facility Name
Investigational Site Number 840104
City
Fort Meyers
State/Province
Florida
ZIP/Postal Code
33919
Country
United States
Facility Name
Investigational Site Number 840006
City
Augusta
State/Province
Georgia
ZIP/Postal Code
30912
Country
United States
Facility Name
Investigational Site Number 840011
City
Maywood
State/Province
Illinois
ZIP/Postal Code
60153
Country
United States
Facility Name
Investigational Site Number 840010
City
Kansas City
State/Province
Kansas
ZIP/Postal Code
66160-7321
Country
United States
Facility Name
Investigational Site Number 840013
City
Lexington
State/Province
Kentucky
ZIP/Postal Code
40536
Country
United States
Facility Name
Investigational Site Number 840007
City
Paducah
State/Province
Kentucky
ZIP/Postal Code
42002
Country
United States
Facility Name
Investigational Site Number 840004
City
Boston
State/Province
Massachusetts
ZIP/Postal Code
02115
Country
United States
Facility Name
Investigational Site Number 840015
City
St Louis
State/Province
Missouri
ZIP/Postal Code
63110
Country
United States
Facility Name
Investigational Site Number 840014
City
Canton
State/Province
Ohio
ZIP/Postal Code
44718
Country
United States
Facility Name
Investigational Site Number 840001
City
Philadelphia
State/Province
Pennsylvania
ZIP/Postal Code
19111
Country
United States
Facility Name
Investigational Site Number 840002
City
Morgantown
State/Province
West Virginia
ZIP/Postal Code
26506
Country
United States
Facility Name
Investigational Site Number 036002
City
Clayton
ZIP/Postal Code
3168
Country
Australia
Facility Name
Investigational Site Number 036001
City
Hobart
ZIP/Postal Code
7001
Country
Australia
Facility Name
Investigational Site Number 036005
City
Kingswood
ZIP/Postal Code
2747
Country
Australia
Facility Name
Investigational Site Number 036003
City
Perth
ZIP/Postal Code
6000
Country
Australia
Facility Name
Investigational Site Number 056003
City
Bruxelles
ZIP/Postal Code
1000
Country
Belgium
Facility Name
Investigational Site Number 056002
City
Gent
ZIP/Postal Code
9000
Country
Belgium
Facility Name
Investigational Site Number 056001
City
Leuven
ZIP/Postal Code
3000
Country
Belgium
Facility Name
Investigational Site Number 250002
City
Montpellier
ZIP/Postal Code
34295
Country
France
Facility Name
Investigational Site Number 250001
City
Pierre Benite Cedex
ZIP/Postal Code
69495
Country
France
Facility Name
Investigational Site Number 250004
City
Rennes
ZIP/Postal Code
35033
Country
France
Facility Name
Investigational Site Number 250005
City
Rouen Cedex
ZIP/Postal Code
76038
Country
France
Facility Name
Investigational Site Number 250003
City
Villejuif Cedex
ZIP/Postal Code
94805
Country
France
Facility Name
Investigational Site Number 276003
City
Frankfurt Am Main
ZIP/Postal Code
60590
Country
Germany
Facility Name
Investigational Site Number 276002
City
Jena
ZIP/Postal Code
07747
Country
Germany
Facility Name
Investigational Site Number 276001
City
Ulm
ZIP/Postal Code
89081
Country
Germany
Facility Name
Investigational Site Number 528001
City
Amsterdam
ZIP/Postal Code
1105 AZ
Country
Netherlands
Facility Name
Investigational Site Number 528003
City
Groningen
ZIP/Postal Code
9713 GZ
Country
Netherlands
Facility Name
Investigational Site Number 528002
City
Rotterdam
ZIP/Postal Code
3075 EA
Country
Netherlands

12. IPD Sharing Statement

Citations:
PubMed Identifier
29550382
Citation
Brown JR, Hamadani M, Hayslip J, Janssens A, Wagner-Johnston N, Ottmann O, Arnason J, Tilly H, Millenson M, Offner F, Gabrail NY, Ganguly S, Ailawadhi S, Kasar S, Kater AP, Doorduijn JK, Gao L, Lager JJ, Wu B, Egile C, Kersten MJ. Voxtalisib (XL765) in patients with relapsed or refractory non-Hodgkin lymphoma or chronic lymphocytic leukaemia: an open-label, phase 2 trial. Lancet Haematol. 2018 Apr;5(4):e170-e180. doi: 10.1016/S2352-3026(18)30030-9. Epub 2018 Mar 14. Erratum In: Lancet Haematol. 2018 Jun;5(6):e240.
Results Reference
derived

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

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