A Study of the Safety and Pharmacokinetics of SAR245409 Tablets in Patients With Solid Tumors or Lymphoma

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

Primary Objective:

- To evaluate the safety and tolerability of SAR245409 tablets administered once or twice a day in patients with solid tumors or lymphoma.

Secondary Objectives:

• To evaluate blood levels of SAR245409 after administration of SAR245409 tablets once or twice a day in patients with solid tumors or lymphoma.
• To evaluate the effect of food on blood levels of SAR245409 after administration of SAR245409 tablets in patients with solid tumors or lymphoma.
• To evaluate the effect of SAR245409 on the body after administration of SAR245409 tablets once or twice a day in patients with solid tumors or lymphoma.
• To obtain information on how SAR245409 administered once or twice a day to patients with solid tumors or lymphoma affect disease symptoms and study treatment side effects as reported by the patients on a questionnaire.
• To explore the antitumor activity of SAR245409 tablets administered once or twice a day to patients with solid tumors or lymphoma.

The total study duration per patient will be 58 to 128 days and will include a screening period (1 to 28 days), a food interaction investigation period (when applicable; 4 to 11 days), two 28-day treatment cycles (56 days), an end-of-treatment visit (within 7 days after the last SAR245409 administration) and a follow-up visit (within 30 ± 3 days after the last SAR245409 administration).

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 survival.
• 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.

Exclusion criteria:

• 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 treatment.
• Prior anticancer hormonal therapy within 1 week before the first dose of study treatment.
• 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 virus) infection.
• 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 (anti-HCV) antibodies.
• 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.