Trial record 1 of 1 for:    ARD12130
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A Study of Investigational SAR245409 in Patients With Certain Lymphoma or Leukemia

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Sanofi
ClinicalTrials.gov Identifier:
NCT01403636
First received: July 26, 2011
Last updated: September 18, 2014
Last verified: September 2014

July 26, 2011
September 18, 2014
October 2011
September 2014   (final data collection date for primary outcome measure)
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 ]
Same as current
Complete list of historical versions of study NCT01403636 on ClinicalTrials.gov Archive Site
Progression free survival (PFS) at 6 months [ Time Frame: 6 months to 2 years ] [ Designated as safety issue: No ]
Same as current
Not Provided
Not Provided
 
A Study of Investigational SAR245409 in Patients With Certain Lymphoma or Leukemia
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.

Interventional
Phase 2
Allocation: Non-Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
Lymphoma
Drug: SAR245409
Pharmaceutical form:capsule Route of administration: oral
  • Experimental: mantle cell
    50 mg twice daily: no eating for 2 hours prior and 1 hour after dose
    Intervention: Drug: SAR245409
  • Experimental: follicular lymphoma
    50 mg twice daily: no eating for 2 hours prior and 1 hour after dose
    Intervention: Drug: SAR245409
  • Experimental: CLL/SLL
    50 mg twice daily:no eating for 2 hours prior and 1 hour after dose
    Intervention: Drug: SAR245409
  • Experimental: Diffuse large B cell lymphoma
    50 mg twice daily:no eating for 2 hours prior and 1 hour after dose
    Intervention: Drug: SAR245409
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
167
September 2014
September 2014   (final data collection date for primary outcome measure)

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.

Both
18 Years and older
No
Contact information is only displayed when the study is recruiting subjects
Australia,   Belgium,   France,   Germany,   Netherlands,   United States
 
NCT01403636
ARD12130, 2011-001616-57, U1111-1118-6417
Yes
Sanofi
Sanofi
Not Provided
Study Director: Clinical Sciences & Operations Sanofi
Sanofi
September 2014

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP