Status:
COMPLETED
Study Combining SAR245409 With Rituximab or Bendamustine Plus Rituximab in Patients With Indolent Lymphoma, Mantle Cell Lymphoma and Chronic Lymphocytic Leukemia
Lead Sponsor:
Sanofi
Conditions:
Indolent Non-Hodgkin Lymphoma
Mantle Cell Lymphoma
Eligibility:
All Genders
18+ years
Phase:
PHASE1
Brief 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 S...
Detailed Description
All subjects will take SAR245409 twice daily. All subjects will receive SAR245409 as long as there is clinical benefit. Combination therapy with SAR245409, bendamustine and rituximab , will be admini...
Eligibility Criteria
Inclusion
- 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.
Exclusion
Key Trial Info
Start Date :
December 1 2011
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
May 1 2014
Estimated Enrollment :
37 Patients enrolled
Trial Details
Trial ID
NCT01410513
Start Date
December 1 2011
End Date
May 1 2014
Last Update
April 1 2016
Active Locations (3)
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1
Investigational Site Number 840004
Aurora, Colorado, United States, 80045
2
Investigational Site Number 840006
Augusta, Georgia, United States, 30912
3
Investigational Site Number 840002
Charleston, South Carolina, United States, 29406