Overview

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

Status:
Completed
Trial end date:
2014-09-01
Target enrollment:
0
Participant gender:
All
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
Phase:
Phase 2
Accepts Healthy Volunteers?
No
Details
Lead Sponsor:
Sanofi
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.