Neoplasm Malignant
Conditions
Brief summary
Primary Objectives: * To determine safety and the maximum tolerated dose (MTD) of SAR405838 through the characterization of dose-limiting toxicities (DLTs). * To assess biological activities in patients with dedifferentiated liposarcoma during MTD cohort expansion. Secondary Objectives: * Pharmacokinetic (PK) profile of SAR405838. * Biomarkers in association with SAR405838. * Anti-tumor activity in response to SAR405838. * Food effect on SAR405838 PK. * Compliance with SAR405838 treatment. * Cytochrome P450 3A4/5 (CYP3A4/5) activity.
Detailed description
Total duration of study participation for each patient will be one month screening followed by treatment until precluded by toxicity, noncompliance, progression, or death.
Interventions
DRUGSAR405838
Pharmaceutical form: Capsule Route of administration: Oral
Sponsors
Sanofi
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* Histologically or cytologically confirmed diagnosis of a solid tumor for which no further effective standard treatment is available. Patients with lymphomas may be enrolled. * For dose escalation, tumor type that has high biomarker prevalence without molecular confirmation of biomarker status, or any tumor type with molecular confirmation of biomarker status; For MTD cohort expansion, only dedifferentiated liposarcoma will be included. * Presence of locally advanced or metastatic disease with at least one measurable lesion.
Exclusion criteria
* Age \<18 years. * Eastern Cooperative Oncology Group (ECOG) performance status of \>1. * Life expectancy \<12 weeks. * Unstable brain or leptomeningeal disease based on history and physical examination. * Inadequate organ functions, positive pregnancy test. * Pregnancy or breast-feeding. * Any anti-cancer drug therapy within 2 weeks (8 weeks for mitomycin C or nitrosoureas) or 5 half-lives of the drug prior to study treatment, whichever is shorter, prior to study treatment. * Unwillingness, if not postmenopausal or surgically sterile, to abstain from sexual intercourse or employ an effective barrier or medical method of contraception during the study drug administration and follow-up periods. * Recent (3 months) history of acute pancreatitis. 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 |
|---|---|
| SAR405838 Maximum tolerated dose (MTD) | Cycle 1 (21 days) or 2 Cycles (42 days) dependent on dosing schedule |
| In MTD cohort, clinical benefit | Until disease progression |
Secondary
| Measure | Time frame |
|---|---|
| Biomarkers | Baseline to end of study |
| Adverse events (eg, number of patients experiencing AEs) | Baseline to end of study |
| Drug administration compliance | Baseline to end of study |
| Clinical response | Baseline to end of study |
| PK parameters (Cmax, Tmax, AUC) | Baseline to end of study |
Countries
France, Netherlands, United States
Outcome results
None listed