Trial record 1 of 1 for:    NCT01403636
Previous Study | Return to List | Next Study

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

This study is ongoing, but not recruiting participants.
Sponsor:
Information provided by (Responsible Party):
Sanofi
ClinicalTrials.gov Identifier:
NCT01403636
First received: July 26, 2011
Last updated: July 21, 2014
Last verified: July 2014
  Purpose

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

Condition Intervention Phase
Lymphoma
Drug: SAR245409
Phase 2

Study Type: Interventional
Study Design: Allocation: Non-Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: 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

Resource links provided by NLM:


Further study details as provided by Sanofi:

Primary Outcome Measures:
  • Objective response rate (ORR) as defined as the proportion of patients who experience complete response/remission (CR) or partial response/remission (PR) [ Time Frame: 2 months to 2 years ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Progression free survival (PFS) at 6 months [ Time Frame: 6 months to 2 years ] [ Designated as safety issue: No ]

Estimated Enrollment: 162
Study Start Date: October 2011
Estimated Study Completion Date: July 2014
Estimated Primary Completion Date: July 2014 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: mantle cell
50 mg twice daily: no eating for 2 hours prior and 1 hour after dose
Drug: SAR245409
Pharmaceutical form:capsule Route of administration: oral
Experimental: follicular lymphoma
50 mg twice daily: no eating for 2 hours prior and 1 hour after dose
Drug: SAR245409
Pharmaceutical form:capsule Route of administration: oral
Experimental: CLL/SLL
50 mg twice daily:no eating for 2 hours prior and 1 hour after dose
Drug: SAR245409
Pharmaceutical form:capsule Route of administration: oral
Experimental: Diffuse large B cell lymphoma
50 mg twice daily:no eating for 2 hours prior and 1 hour after dose
Drug: SAR245409
Pharmaceutical form:capsule Route of administration: oral

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.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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.

  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01403636

  Show 31 Study Locations
Sponsors and Collaborators
Sanofi
Investigators
Study Director: Clinical Sciences & Operations Sanofi
  More Information

No publications provided

Responsible Party: Sanofi
ClinicalTrials.gov Identifier: NCT01403636     History of Changes
Other Study ID Numbers: ARD12130, 2011-001616-57, U1111-1118-6417
Study First Received: July 26, 2011
Last Updated: July 21, 2014
Health Authority: United States: Food and Drug Administration

Additional relevant MeSH terms:
Leukemia
Leukemia, Lymphocytic, Chronic, B-Cell
Lymphoma
Lymphoma, Follicular
Lymphoma, Large B-Cell, Diffuse
Neoplasms by Histologic Type
Neoplasms
Leukemia, B-Cell
Leukemia, Lymphoid
Lymphoproliferative Disorders
Lymphatic Diseases
Immunoproliferative Disorders
Immune System Diseases
Lymphoma, Non-Hodgkin
Lymphoma, B-Cell

ClinicalTrials.gov processed this record on July 28, 2014