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

Status: Recruiting
Phase:
Diagnosis: Non-Hodgkin's Lymphoma, Leukemia/MDS
NCT ID: NCT01403636 (View complete trial on ClinicalTrials.gov)
DFCI Protocol ID: 11-432

 

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), or chronic lymphocytic leukemia (CLL)/small lymphocytic lymphoma (SLL) 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, 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

 

Conducting Institutions:
Dana-Farber Cancer Institute, Beth-Israel Deaconess Medical Center

Overall PI:
Jennifer Brown, MD, PhD, Dana-Farber Cancer Institute

Site-responsible Investigators:
Jon Arnason, MD, Beth Israel Deaconess Medical Center

Contacts:
Dana-Farber Cancer Institute: Ilene Galinsky, 617-632-3902, igalinsky@partners.org
Beth-Israel Deaconess Medical Center: Cancer Trials Call Center, 617-667-3060

Eligibility 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 - Eastern Cooperative Oncology Group (ECOG) performance status < or = 2 - 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 - Central nervous system or leptomeningeal involvement - Positive Hepatitis B surface antigen (HBsAg) or Hepatitis C antibody (anti-HCV) serology The above information is not intended to contain all considerations relevant to a patient's potential participation in a clinical trial.
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