Study Combining SAR245409 With Rituximab or Bendamustine Plus Rituximab in Patients With Indolent Lymphoma, Mantle Cell Lymphoma and Chronic Lymphocytic Leukemia

• Status: Completed
• Trial end date: 2014-05-01
• Target enrollment: 0
• Participant gender: All

Summary

Primary Objective:

• To determine the maximum tolerated dose (MTD) and recommended Phase 2 dose (RP2D) for SAR245409 when administered in combination with rituximab or bendamustine plus rituximab

Secondary Objectives:

• To determine the safety and tolerability of SAR245409 in combination with rituximab or bendamustine plus rituximab in subjects with indolent Hon-Hodgkin Lymphoma (iNHL) Mantle Cell Lymphoma (MCL) or Chronic Lymphocytic Leukemia (CLL)

• To determine the pharmacokinetics (PK) of SAR245409, bendamustine and rituximab when used in combination in subjects with iNHL, MCL or CLL

• To determine the pharmacodynamic (PD) effects of SAR245409 in combination with rituximab or bendamustine plus rituximab in subjects with iNHL, MCL or CLL

• To determine the antitumor activity of SAR245409 in combination with rituximab or bendamustine plus rituximab in subjects with iNHL, MCL or CLL

• Phase: Phase 1
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Sanofi
• Treatments: Bendamustine Hydrochloride; Rituximab

Criteria

Inclusion criteria:

• A confirmed diagnosis of indolent non-Hodgkin lymphoma, mantle cell lymphoma or chronic lymphocytic leukemia

• Evaluable disease or measurable disease

• Transfusion independent

• Able to take oral medication

• Male and Female subjects > 18 years

• Eastern Cooperative Oncology Group (ECOG) performance status ≤ 2

• Women of childbearing potential using adequate contraception

Exclusion criteria:

• Prior therapy with a PI3K, mTOR or dual PI3K/mTOR inhibitor resulting in adverse events necessitating treatment discontinuation

• Eligible for a hematopoietic stem cell transplant (HSCT)

• The subject has received investigational or non-investigational cytotoxic chemotherapy (i.e., cyclophosphamide), small molecule cancer therapy (i.e., imatinib), biologic cancer therapies other than rituximab (i.e., alemtuzumab, cytokines, vaccines or other monoclonal antibodies) hormonal therapy, radio- or immuno- conjugates (e.g. ibritumomab tiuxetan, tositumomab) or immunosuppressants to treat malignancy within 4 weeks prior to Cycle 1, Day 1

• Radiation therapy within 2 weeks prior to Cycle 1, Day 1

• Autologous Hematopoietic Stem Cell Transplant (HSCT) within the past 16 weeks

• Prior allogeneic HSCT

• Active central nervous system (CNS) metastases or leptomeningeal involvement

• Positive Hepatitis B surface antigen (HBsAg) or Hepatitis C Antibody (anti-HCV)

• Hereditary or acquired immunodeficiency syndrome or human immunodeficiency virus (HIV) infection

• Active peptic ulcer disease requiring treatment with proton pump inhibitors (e.g. pantoprazole) or Type 2 histamine antagonists (e.g. cimetidine)

• Diagnosis or treatment for another malignancy within 3 years of enrollment with the exception of complete resection of basal cell or squamous cell carcinoma of the skin, an in situ malignancy or low-risk prostate cancer after curative therapy

• Inadequate bone marrow function

• Abnormal liver function

• Abnormal renal function

• Abnormal coagulation

The above information is not intended to contain all considerations relevant to a patient's potential participation in a clinical trial.