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

Completed · Phase 2

Conditions studied: Lymphoma

In brief

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

Key facts

Study ID

NCT01403636

Run by

Sanofi

People needed

167

Starts

2011-10-01

Expected to finish

2014-09-01

Last updated by the study team

2016-03-17

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

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
• 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.

Where it is running

• Investigational Site Number 840012 — Los Angeles, California, United States
• Investigational Site Number 840104 — Fort Meyers, Florida, United States
• Investigational Site Number 840006 — Augusta, Georgia, United States
• Investigational Site Number 840011 — Maywood, Illinois, United States
• Investigational Site Number 840010 — Kansas City, Kansas, United States
• Investigational Site Number 840013 — Lexington, Kentucky, United States
• Investigational Site Number 840007 — Paducah, Kentucky, United States
• Investigational Site Number 840004 — Boston, Massachusetts, United States
• Investigational Site Number 840015 — St Louis, Missouri, United States
• Investigational Site Number 840014 — Canton, Ohio, United States
• Investigational Site Number 840001 — Philadelphia, Pennsylvania, United States
• Investigational Site Number 840002 — Morgantown, West Virginia, United States
• Investigational Site Number 036002 — Clayton, Australia
• Investigational Site Number 036001 — Hobart, Australia
• Investigational Site Number 036005 — Kingswood, Australia
• Investigational Site Number 036003 — Perth, Australia
• Investigational Site Number 056003 — Brussels, Belgium
• Investigational Site Number 056002 — Ghent, Belgium
• Investigational Site Number 056001 — Leuven, Belgium
• Investigational Site Number 250002 — Montpellier, France
• Investigational Site Number 250001 — Pierre-Bénite, France
• Investigational Site Number 250004 — Rennes, France
• Investigational Site Number 250005 — Rouen, France
• Investigational Site Number 250003 — Villejuif, France
• Investigational Site Number 276003 — Frankfurt am Main, Germany

Full record on ClinicalTrials.gov

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