A Study of the Safety and Pharmacokinetics of SAR245409 Tablets in Patients With Solid Tumors or Lymphoma
Status and phase
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Study type
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Details and patient eligibility
About
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.
Full 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).
Enrollment
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Volunteers
Inclusion and exclusion 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.
Trial design
Primary purpose
Allocation
Interventional model
Masking
49 participants in 2 patient groups
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Data sourced from clinicaltrials.gov
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