A Phase 1 Dose-escalation Study of the Safety and Pharmacokinetics of a Tablet Formulation of SAR245409 Administered Daily to Patients With Solid Tumors or Lymphoma
Inclusion criteria :
- Solid tumor that is metastatic or unresectable, or relapsed or refractory lymphoma
(including chronic lymphocytic leukemia/small lymphocytic lymphoma), for which
standard therapies are no longer effective or there are no therapies known to prolong
- Male or female patient > or = 18 years old.
- Eastern Cooperative Oncology Group Performance Status < or = 1.
- Adequate white blood cells, platelets and haemoglobin.
- Adequate liver and kidney functions.
- Fasting plasma glucose < 160 mg/dL.
- No other malignancy.
- Women of childbearing potential using adequate contraception.
- History of partial or full gastrectomy.
- Lymphoma involving the gastrointestinal tract.
- Uncontrolled brain metastases or a primary brain tumor.
- Prior treatment with cytotoxic chemotherapy (including investigational agents) or
biologic agents (antibodies, immune modulators, and cytokines) within 4 weeks, or
nitrosoureas or mitomycin C within 6 weeks, before the first dose of study treatment.
- Prior treatment with a small-molecule kinase inhibitor (including investigational
agents) within 2 weeks, or 5 half lives of the drug or active metabolites, whichever
is longer, before the first dose of study treatment.
- Any other investigational therapy within 4 weeks before the first dose of study
- Prior anticancer hormonal therapy within 1 week before the first dose of study
- Prior radiation therapy within 2 weeks before the first dose of study treatment.
- Intolerance of prior treatment with a PI3K inhibitor.
- Hereditary or acquired immunodeficiency syndrome or HIV (human immunodeficiency
- Lymphoma patients with positive serologies for Hepatitis B surface antigen (HBsAg) or
anti-Hepatitis C virus (anti-HCV) antibodies.
- Positive serologies for Hepatitis B surface antigen (HBsAg) or anti-Hepatitis C virus
- Patient is pregnant or breastfeeding.
The above information is not intended to contain all considerations relevant to a
patient's potential participation in a clinical trial.