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A Phase 1b, Multicenter, Open-Label, Dose Escalation Study of SAR245409 to Evaluate the Safety, Tolerability and Clinical Activity of SAR245409 in Combination With Rituximab or Bendamustine Plus Rituximab in Subjects With Relapsed or Refractory Indolent B-cell Non-Hodgkin Lymphoma, Mantle Cell Lymphoma or Chronic Lymphocytic Leukemia


Phase 1
18 Years
N/A
Open (Enrolling)
Both
Indolent Non-Hodgkin Lymphoma, Mantle Cell Lymphoma, Chronic Lymphocytic Leukemia

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Trial Information

A Phase 1b, Multicenter, Open-Label, Dose Escalation Study of SAR245409 to Evaluate the Safety, Tolerability and Clinical Activity of SAR245409 in Combination With Rituximab or Bendamustine Plus Rituximab in Subjects With Relapsed or Refractory Indolent B-cell Non-Hodgkin Lymphoma, Mantle Cell Lymphoma or Chronic Lymphocytic Leukemia


All subjects will take SAR245409 twice daily. All subjects will receive SAR245409 as long as
there is clinical benefit.

Combination therapy with SAR245409 and either bendamustine or rituximab as doublet therapy,
or with bendamustine and rituximab as triplet therapy, will be administered over a 28 day
cycle.

Subjects receiving the doublet containing rituximab will receive rituximab for 4 - 8 weeks.

Subjects with iNHL or MCL receiving bendamustine as a triplet therapy will receive a maximum
of 8 cycles of therapy. Subjects CLL receiving bendamustine as a triplet therapy will
receive a maximum of 6 cycles of therapy.

Inclusion 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.
pamtoprazole) 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.

Type of Study:

Interventional

Study Design:

Allocation: Non-Randomized, Endpoint Classification: Safety Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Outcome Measure:

Identification Of Dose-Limiting Toxicity (DLT) and Maximum Tolerated Dose (MTD)

Outcome Time Frame:

4 weeks to 8 weeks

Safety Issue:

Yes

Principal Investigator

Clinical Sciences & Operations

Investigator Role:

Study Director

Investigator Affiliation:

Sanofi

Authority:

United States: Food and Drug Administration

Study ID:

TCD12012

NCT ID:

NCT01410513

Start Date:

December 2011

Completion Date:

December 2014

Related Keywords:

  • Indolent Non-Hodgkin Lymphoma
  • Mantle Cell Lymphoma
  • Chronic Lymphocytic Leukemia
  • Leukemia
  • Leukemia, Lymphocytic, Chronic, B-Cell
  • Leukemia, Lymphoid
  • Lymphoma
  • Lymphoma, Non-Hodgkin
  • Lymphoma, B-Cell
  • Lymphoma, Mantle-Cell

Name

Location

Investigational Site Number 840006 Augusta, Georgia  30912
Investigational Site Number 840004 Aurora, Colorado  80045
Investigational Site Number 840001 New Brunswick, New Jersey  08903
Investigational Site Number 840002 Charleston, South Carolina  29406
Investigational Site Number 840003 Dallas, Texas  75230