Patient case: 62-year-old male with cholangiocarcinoma; genetic feature: PIK3CA (1047H)

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

Summary: 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.

Detailed description: 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).

Eligibility: 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.

Relevance to patient case: not relevant