A Phase 1 interventional study of SAR245409 in Neoplasm Malignant, sponsored by Sanofi. Completed at 3 sites in United States. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2020-10-28.
Sponsored by Sanofi · Phase 1, Interventional, and Other
Primary Objective:
Secondary Objectives:
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).
9,365 studies on the registry are indexed under Neoplasms; 2,486 are open to participants now.
This study's enrollment of 49 is close to the median of 50 across 7,250 interventional studies indexed under Neoplasms.
Browse Neoplasms studies →Sanofi is the lead sponsor of 1,508 studies on the registry; 90 are open to participants now.
Of its 198 completed or terminated interventional studies of FDA-regulated products, 118 (60%) have results posted.
Counted across the registry records on this site, refreshed daily.
Exclusion criteria:
The above information is not intended to contain all considerations relevant to a patient's potential participation in a clinical trial.
escalating doses, once daily dosing every day, no eating for 2 hours prior and 1 hour after dose
Drug: SAR245409
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
Dose Limiting Toxicities
Time frame: Up to Day 28
Number of patients with treatment-emergent adverse events
Time frame: From first dose of SAR245409 until 30 days after the last dose
Maximum SAR245409 plasma concentration
Time frame: Cycle 1 Days 1, 2, 8, 15, and 28, and Cycle 2 Day 1
Area under the SAR245409 plasma concentration versus time curve
Time frame: 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
Time frame: 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
Time frame: Days 1, 2, 3, and 4 of the food interaction period
This study is completed, as verified in Oct 2014. You cannot join it, but the record below documents what was studied.
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Sanofi