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



Status:Completed
Conditions:Blood Cancer, Lymphoma
Therapuetic Areas:Oncology
Healthy:No
Age Range:18 - Any
Updated:4/21/2016
Start Date:October 2011
End Date:September 2014

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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

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

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.

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.
We found this trial at
13
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