Lymphoma MedDRA version: 13.1 Level: PT Classification code 10025310 Term: Lymphoma System Organ Class: 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Conditions
Interventions
Product Code: SAR245409
Pharmaceutical Form: Capsule, hard
Current Sponsor code: SAR245409
Concentration unit: mg milligram(s)
Concentration type: equal
Concentration number: 10-
Product Code: SAR245
Sponsors
sanofi-aventis recherche & développement
Eligibility
Sex/Gender
All
Inclusion 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 Patient > or = 18 years old ECOG performance status =65 years) yes F.1.3.1 Number of subjects for this age range 28
Exclusion criteria
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 - Central nervous system or leptomeningeal involvement - Positive Hepatitis B surface antigen (HBsAg) or Hepatitis C antibody (anti-HCV) serology
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main 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), or chronic lymphocytic leukemia (CLL)/small lymphocytic lymphoma (SLL);Secondary Objective: - 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, or CLL/SLL treated with SAR245409 - To evaluate the safety and tolerability of SAR245409 in patients with MCL, FL, or CLL/SLL - To further characterize the plasma pharmacokinetics (PK) of SAR245409 in patients with MCL, FL, or CLL/SLL ;Primary end point(s): Objective response rate (ORR) as defined as the proportion of patients who experience complete response/remission (CR) or partial response/remission (PR);Timepoint(s) of evaluation of this end point: 2 months to 2 years | — |
Secondary
| Measure | Time frame |
|---|---|
| Secondary end point(s): Progression free survival (PFS) at 6 months;Timepoint(s) of evaluation of this end point: 6 months to 2 years | — |
Countries
Australia, Belgium, Germany, United States
Contacts
Public ContactJean Van Rampelbergh
sanofi-aventis Belgium
Outcome results
None listed