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
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.
Phase
Phase 2 - takes the treatment one step further, assessing the activity of a particular therapy in a disease, often building upon leads from the Phase I trial. While patients are generally required to be previously untreated, participation in a Phase II trial doesn't usually preclude the patient from getting the standard treatment after they've received the investigational agent. At best they are allowed to get a new drug they wouldn't be able to get otherwise that may turn out to be better for their disease.Inclusion and Exclusion 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
- 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
- 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
-
California
- Investigational Site Number 840012, Los Angeles, California, 90033
-
Arkansas
- Investigational Site Number 840018, Hot Springs, Arkansas, 71913
-
Missouri
- Investigational Site Number 840015, St Louis, Missouri, 63110
-
Kentucky
- Investigational Site Number 840007, Paducah, Kentucky, 42002
- Investigational Site Number 840013, Lexington, Kentucky, 40536
-
Illinois
- Investigational Site Number 840011, Maywood, Illinois, 60153
-
Germany
- Investigational Site Number 276001, Ulm, 89081
-
France
- Investigational Site Number 250003, Villejuif Cedex, 94805
- Investigational Site Number 250004, Rennes, 35033
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