A Phase 2 interventional study of SAR245409 in Lymphoma, sponsored by Sanofi. Completed at 30 sites in 6 countries. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2016-03-17.
Sponsored by Sanofi · Phase 2, Interventional, and Treatment
Primary Objective:
Secondary Objectives:
There is a 21 day screening period followed by 28 day cycles. Patients will continue to receive SAR245409 as long as there is clinical benefit or until a study withdrawal criterion is met. The last posttreatment visit will be 30 days after the last dose or until IMP-related toxicities have resolved or are deemed irreversible, whichever is later.
5,578 studies on the registry are indexed under Lymphoma; 825 are open to participants now.
This study's enrollment of 167 is above the median of 40 across 4,508 interventional studies indexed under Lymphoma.
Browse Lymphoma 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.
50 mg twice daily: no eating for 2 hours prior and 1 hour after dose
Drug: SAR245409
50 mg twice daily: no eating for 2 hours prior and 1 hour after dose
Drug: SAR245409
50 mg twice daily:no eating for 2 hours prior and 1 hour after dose
Drug: SAR245409
50 mg twice daily:no eating for 2 hours prior and 1 hour after dose
Drug: SAR245409
Pharmaceutical form:capsule Route of administration: oral
Objective response rate (ORR) as defined as the proportion of patients who experience complete response/remission (CR) or partial response/remission (PR)
Time frame: 2 months to 2 years
Progression free survival (PFS) at 6 months
Time frame: 6 months to 2 years
This study is completed, as verified in Feb 2016. You cannot join it, but the record below documents what was studied.
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Sanofi