Neoplasm Malignant
Conditions
Brief 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).
Interventions
DRUGSAR245409
Pharmaceutical form: tablet Route of administration: oral
Sponsors
Sanofi
Study design
Allocation
NON_RANDOMIZED
Intervention model
PARALLEL
Primary purpose
OTHER
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Dose Limiting Toxicities | Up to Day 28 |
Secondary
| Measure | Time frame |
|---|---|
| Number of patients with treatment-emergent adverse events | From first dose of SAR245409 until 30 days after the last dose |
| Maximum SAR245409 plasma concentration | Cycle 1 Days 1, 2, 8, 15, and 28, and Cycle 2 Day 1 |
| Area under the SAR245409 plasma concentration versus time curve | Cycle 1 Days 1, 2, 8, 15, and 28, and Cycle 2 Day 1 |
| Ratio of maximum SAR245409 plasma concentration between fed and fasted dosing | Days 1, 2, 3, and 4 of the food interaction period |
| Ratio of area under the SAR245409 plasma concentration versus time curve between fed and fasted dosing | Days 1, 2, 3, and 4 of the food interaction period |
Countries
United States
Outcome results
None listed