NCT lookup

Pull any trial record directly from ClinicalTrials.gov.

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

CompletedPhase 1

Sponsor: Sanofi

Conditions: Neoplasm Malignant

Interventions: SAR245409

Countries: United States

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.

Eligibility overview

Sex: ALL

Age: 18 Years to —

Healthy volunteers: No

Study type: INTERVENTIONAL

Eligibility criteria

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.

Locations (3)

Detroit, Michigan, United States
New Brunswick, New Jersey, United States
Dallas, Texas, United States