NCT01403636

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

Trial Health

93
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
167

participants targeted

Target at P75+ for phase_2 lymphoma

Timeline
Completed

Started Oct 2011

Shorter than P25 for phase_2 lymphoma

Geographic Reach
6 countries

30 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

July 26, 2011

Completed
1 day until next milestone

First Posted

Study publicly available on registry

July 27, 2011

Completed
2 months until next milestone

Study Start

First participant enrolled

October 1, 2011

Completed
2.9 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 1, 2014

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

September 1, 2014

Completed
Last Updated

March 17, 2016

Status Verified

February 1, 2016

Enrollment Period

2.9 years

First QC Date

July 26, 2011

Last Update Submit

February 17, 2016

Conditions

Lymphoma

Outcome Measures

Primary Outcomes (1)

  • 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 Outcomes (1)

  • Progression free survival (PFS) at 6 months

    6 months to 2 years

Study Arms (4)

mantle cell

EXPERIMENTAL

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

Drug: SAR245409

follicular lymphoma

EXPERIMENTAL

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

Drug: SAR245409

CLL/SLL

EXPERIMENTAL

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

Drug: SAR245409

Diffuse large B cell lymphoma

EXPERIMENTAL

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

Drug: SAR245409

Interventions

SAR245409DRUG

Pharmaceutical form:capsule Route of administration: oral

CLL/SLLDiffuse large B cell lymphomafollicular lymphomamantle cell

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • 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
  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (30)

Investigational Site Number 840012

Los Angeles, California, 90033, United States

Location

Investigational Site Number 840104

Fort Meyers, Florida, 33919, United States

Location

Investigational Site Number 840006

Augusta, Georgia, 30912, United States

Location

Investigational Site Number 840011

Maywood, Illinois, 60153, United States

Location

Investigational Site Number 840010

Kansas City, Kansas, 66160-7321, United States

Location

Investigational Site Number 840013

Lexington, Kentucky, 40536, United States

Location

Investigational Site Number 840007

Paducah, Kentucky, 42002, United States

Location

Investigational Site Number 840004

Boston, Massachusetts, 02115, United States

Location

Investigational Site Number 840015

St Louis, Missouri, 63110, United States

Location

Investigational Site Number 840014

Canton, Ohio, 44718, United States

Location

Investigational Site Number 840001

Philadelphia, Pennsylvania, 19111, United States

Location

Investigational Site Number 840002

Morgantown, West Virginia, 26506, United States

Location

Investigational Site Number 036002

Clayton, 3168, Australia

Location

Investigational Site Number 036001

Hobart, 7001, Australia

Location

Investigational Site Number 036005

Kingswood, 2747, Australia

Location

Investigational Site Number 036003

Perth, 6000, Australia

Location

Investigational Site Number 056003

Brussels, 1000, Belgium

Location

Investigational Site Number 056002

Ghent, 9000, Belgium

Location

Investigational Site Number 056001

Leuven, 3000, Belgium

Location

Investigational Site Number 250002

Montpellier, 34295, France

Location

Investigational Site Number 250001

Pierre-Bénite, 69495, France

Location

Investigational Site Number 250004

Rennes, 35033, France

Location

Investigational Site Number 250005

Rouen, 76038, France

Location

Investigational Site Number 250003

Villejuif, 94805, France

Location

Investigational Site Number 276003

Frankfurt am Main, 60590, Germany

Location

Investigational Site Number 276002

Jena, 07747, Germany

Location

Investigational Site Number 276001

Ulm, 89081, Germany

Location

Investigational Site Number 528001

Amsterdam, 1105 AZ, Netherlands

Location

Investigational Site Number 528003

Groningen, 9713 GZ, Netherlands

Location

Investigational Site Number 528002

Rotterdam, 3075 EA, Netherlands

Location

Related Publications (1)

  • 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.

    PMID: 29550382DERIVED

MeSH Terms

Conditions

Lymphoma

Interventions

XL765

Condition Hierarchy (Ancestors)

Neoplasms by Histologic TypeNeoplasmsLymphoproliferative DisordersLymphatic DiseasesHemic and Lymphatic DiseasesImmunoproliferative DisordersImmune System Diseases

Study Officials

  • Clinical Sciences & Operations

    Sanofi

    STUDY DIRECTOR

Study Design

Study Type
interventional
Phase
phase 2
Allocation
NON RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

July 26, 2011

First Posted

July 27, 2011

Study Start

October 1, 2011

Primary Completion

September 1, 2014

Study Completion

September 1, 2014

Last Updated

March 17, 2016

Record last verified: 2016-02

Locations

US(12)DE(3)FR(5)BE(3)AU(4)NL(3)