Clinical trial · Interventional
A Study of the Safety and Pharmacokinetics of SAR245409 Tablets in Patients With Solid Tumors or Lymphoma
A Phase 1 Dose-escalation Study of the Safety and Pharmacokinetics of a Tablet Formulation of SAR245409 Administered Daily to Patients With Solid Tumors or Lymphoma
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
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.
Conditions
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Neoplasm Malignant | Malignant Neoplasm | ALIAS | 0.90 |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| SAR245409 | Drug | — | UNRESOLVED |
Design
Arms and outcomes
Arms (2)
- type
- EXPERIMENTAL
- label
- Once daily dosing
- description
- escalating doses, once daily dosing every day, no eating for 2 hours prior and 1 hour after dose
- interventionNames
- Drug: SAR245409
- type
- EXPERIMENTAL
- label
- Twice daily dosing
- description
- escalating doses, twice daily dosing every day, no eating for 2 hours prior and 1 hour after dose
- interventionNames
- Drug: SAR245409
Primary outcomes (1)
- measure
- Dose Limiting Toxicities
- timeFrame
- Up to Day 28
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
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.
References
Publications (0)
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