Overview

This trial is active, not recruiting.

Condition lymphoma
Treatment sar245409
Phase phase 2
Targets PI3K, mTOR
Sponsor Sanofi
Start date October 2011
End date September 2014
Trial size 167 participants
Trial identifier NCT01403636, 2011-001616-57, ARD12130, U1111-1118-6417

Summary

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

United States No locations recruiting
Other Countries No locations recruiting

Study Design

Allocation non-randomized
Endpoint classification efficacy study
Intervention model parallel assignment
Masking open label
Primary purpose treatment
Arm
(Experimental)
50 mg twice daily: no eating for 2 hours prior and 1 hour after dose
sar245409
Pharmaceutical form:capsule Route of administration: oral
(Experimental)
50 mg twice daily: no eating for 2 hours prior and 1 hour after dose
sar245409
Pharmaceutical form:capsule Route of administration: oral
(Experimental)
50 mg twice daily:no eating for 2 hours prior and 1 hour after dose
sar245409
Pharmaceutical form:capsule Route of administration: oral
(Experimental)
50 mg twice daily:no eating for 2 hours prior and 1 hour after dose
sar245409
Pharmaceutical form:capsule Route of administration: oral

Primary Outcomes

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

Secondary Outcomes

Measure
Progression free survival (PFS) at 6 months
time frame: 6 months to 2 years

Eligibility Criteria

Male or female participants at least 18 years old.

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.

Additional Information

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
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.
Trial information was received from ClinicalTrials.gov and was last updated in September 2014.
Information provided to ClinicalTrials.gov by Sanofi.