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.