A Study of the Safety and Pharmacokinetics of SAR245409 Tablets in Patients With Solid Tumors or Lymphoma
Study Details
Study Description
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:
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To evaluate blood levels of SAR245409 after administration of SAR245409 tablets once or twice a day in patients with solid tumors or lymphoma.
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To evaluate the effect of food on blood levels of SAR245409 after administration of SAR245409 tablets in patients with solid tumors or lymphoma.
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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.
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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.
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To explore the antitumor activity of SAR245409 tablets administered once or twice a day to patients with solid tumors or lymphoma.
| Condition or Disease | Intervention/Treatment | Phase |
|---|---|---|
| Phase 1 |
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).
Study Design
Arms and Interventions
| Arm | Intervention/Treatment |
|---|---|
| Experimental: Once daily dosing escalating doses, once daily dosing every day, no eating for 2 hours prior and 1 hour after dose |
Drug: SAR245409
Pharmaceutical form: tablet Route of administration: oral
|
| Experimental: Twice daily dosing escalating doses, twice daily dosing every day, no eating for 2 hours prior and 1 hour after dose |
Drug: SAR245409
Pharmaceutical form: tablet Route of administration: oral
|
Outcome Measures
Primary Outcome Measures
- Dose Limiting Toxicities [Up to Day 28]
Secondary Outcome Measures
- 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]
Eligibility Criteria
Criteria
Inclusion criteria :
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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.
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Male or female patient > or = 18 years old.
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Eastern Cooperative Oncology Group Performance Status < or = 1.
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Adequate white blood cells, platelets and haemoglobin.
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Adequate liver and kidney functions.
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Fasting plasma glucose < 160 mg/dL.
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No other malignancy.
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Women of childbearing potential using adequate contraception.
Exclusion criteria:
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History of partial or full gastrectomy.
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Lymphoma involving the gastrointestinal tract.
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Uncontrolled brain metastases or a primary brain tumor.
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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.
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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.
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Any other investigational therapy within 4 weeks before the first dose of study treatment.
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Prior anticancer hormonal therapy within 1 week before the first dose of study treatment.
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Prior radiation therapy within 2 weeks before the first dose of study treatment.
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Intolerance of prior treatment with a PI3K inhibitor.
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Hereditary or acquired immunodeficiency syndrome or HIV (human immunodeficiency virus) infection.
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Lymphoma patients with positive serologies for Hepatitis B surface antigen (HBsAg) or anti-Hepatitis C virus (anti-HCV) antibodies.
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Positive serologies for Hepatitis B surface antigen (HBsAg) or anti-Hepatitis C virus (anti-HCV) antibodies.
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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.
Contacts and Locations
Locations
| Site | City | State | Country | Postal Code | |
|---|---|---|---|---|---|
| 1 | Investigational Site Number 840001 | Detroit | Michigan | United States | 48201 |
| 2 | Investigational Site Number 840002 | New Brunswick | New Jersey | United States | 08903 |
| 3 | Investigational Site Number 840003 | Dallas | Texas | United States | 75230 |
Sponsors and Collaborators
- Sanofi
Investigators
- Study Director: Clinical Sciences & Operations, Sanofi
Study Documents (Full-Text)
None provided.More Information
Publications
None provided.- TED12471
- U1111-1123-1488