A study of investigational SAR245409 in patients with certain lymphoma or leukemia

Conditions: ymphoma
MedDRA version: 13.1Level: PTClassification code 10025310Term: LymphomaSystem Organ Class: 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Therapeutic area: Diseases [C] - Cancer [C04]

Registration Number: EUCTR2011-001616-57-BE

Lead Sponsor: sanofi-aventis recherche & développement

Brief Summary: Not available

Detailed Description: Not available

Recruitment & Eligibility

Status: ot Recruiting

Sex: All

Target Recruitment: 138

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 < 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

Are the trial subjects under 18? no
Number of subjects for this age range:
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range 110
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range 28

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

Study & Design

Study Type: Interventional clinical trial of medicinal product

Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
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<br>- To evaluate the safety and tolerability of SAR245409 in patients with MCL, FL, or CLL/SLL<br>- To further characterize the plasma pharmacokinetics (PK) of SAR245409 in patients with MCL, FL, or CLL/SLL<br>;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 Outcome Measures