NCT01587040

Open Label Treatment Extension Study With SAR245408 or SAR245409 as a Monotherapy or as a Combination Regimen

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

• Status: Completed
• Phase: Phase 1 / Phase 2
• Study type: Interventional
• Enrollment: 61 (actual)
• Sponsor: Sanofi · Industry
• Sex: All
• Age: —
• Healthy volunteers: Not accepted

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.

Detailed description

The duration of the study for an individual participant included: 1. Baseline assessments: within 7 days prior to the first dose of investigational medicinal product (IMP). 2. Study treatment period(s): Participants started study treatment at the beginning of the initiation or extension periods based on the length of prior therapy with SAR245408 or SAR245409 * if \<2 cycles, started with initiation period; Participant must have had completed all the visits in the initiation period before moving to the extension period. * if \>=2 cycles, started with extension period; duration of extension period was unlimited. * Participants who took a SAR245408 or SAR245409 daily dose higher than their established dose of SAR245408 or SAR245409, respectively, in the parental study entered the study on Day 1 of the initiation period. * Participants who had dose interrupted in the parental study but fulfilled parental protocol criteria to restart IMP treatment entered the treatment-extension study on Day 1 of the initiation period. * Participants who fulfilled the parental study criteria for IMP treatment continuation but had ongoing Grade 2 adverse events (AEs) entered the treatment-extension study on Day 1 of the initiation period. Participants continued to receive study treatment until disease progression, unacceptable toxicity, withdrawal of consent, or until commercial supplies of SAR245408 or SAR245409 were available to them outside of the clinical trial. 3. Follow-up assessments: 23 to 37 days after the last dose of IMP.

Conditions

• Neoplasm Malignant

Interventions

Type	Name	Description
DRUG	SAR245408	Pharmaceutical form: capsule or tablet Route of administration: oral
DRUG	SAR245409	Pharmaceutical form: capsule or tablet Route of administration: oral

Timeline

• Start date: 2012-07-20
• Primary completion: 2018-05-23
• Completion: 2018-05-23
• First posted: 2012-04-27
• Last updated: 2022-04-19
• Results posted: 2019-06-11

Locations

21 sites across 4 countries: United States, Belgium, France, Spain

Regulatory

• FDA-regulated drug study