At a glance
ClinicalIndex Comparison RecordPhase 2Completed· 61 enrolled
Drug / intervention
SAR245408 +1 moredrug
Likely dose
Not stated in record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.
Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.
International, Multicenter, Open-label, Treatment-extension Study for Subjects Who Completed a Phase 1 or Phase 2 Parental Study to Continue Receiving Treatment With SAR245408 or SAR245409 as a Monotherapy or as a Combination Regimen
In Brief
A Phase 2 clinical trial evaluating SAR245408 and SAR245409 for Neoplasm Malignant. Completed, enrolled 61 participants across 21 sites in 4 countries.
Detailed Summary
Primary Objective: The purpose of this study was to determine the long term safety and tolerability of SAR245408 and SAR245409 as a monotherapy or as part of a combination regimen in participants who were benefiting from treatment.
Study Details
Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsNeoplasm Malignant
CountriesBelgium, France, Spain, United States
Collaborators--
Timeline
Phase 2CompletedFinished
201220132014201520162017201820192020202120222023202420252026
First PostedApr 2012
Enrollment StartJul 2012
Primary CompletionMay 2018
TodayJul 2026
First PostedApr 27, 2012
Enrollment StartJul 20, 2012
Primary CompletionMay 23, 2018
TodayJul 2, 2026
Enrollment to primary: 5.8 yearsPosted 14.2 years ago
Interventions
SAR245408drug
Pharmaceutical form: capsule or tablet Route of administration: oral
SAR245409drug
Pharmaceutical form: capsule or tablet Route of administration: oral