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

Completed · Phase 1

Conditions studied: Neoplasm Malignant

In brief

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.

Key facts

Study ID

NCT01596270

Run by

Sanofi

People needed

49

Starts

2012-06-01

Expected to finish

2014-10-01

Last updated by the study team

2020-10-28

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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.

You may not qualify if…

• 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.

Where it is running

• Investigational Site Number 840001 — Detroit, Michigan, United States
• Investigational Site Number 840002 — New Brunswick, New Jersey, United States
• Investigational Site Number 840003 — Dallas, Texas, United States

Full record on ClinicalTrials.gov

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