drugset / Trial / NCT02920697

Dose-escalation Study of Oral Administration of S 55746 in Patients With Chronic Lymphocytic Leukaemia and B-Cell Non-Hodgkin Lymphoma

NCT02920697

Phase 1 Completed 65 enrolled Servier ADIR, a Servier Group company · collab
Non-randomizedSingle-groupOpen-labelTreatment

Summary

The purpose of this study is to determine the safety profile and tolerability of S 55746 in patients with CLL, B-Cell NHL and MM, in terms of Dose-Limiting Toxicities (DLTs), Maximum Tolerated Dose (MTD) and determine the Recommended Phase 2 Dose (RP2D) through safety profile (DLT, MTD), PK profile, PD profile and preliminary efficacy.

Timeline

Start
2014-03
Primary completion
2018-10-22
Completion
2018-10-22

Publications

  • Background Le Gouill S, Wermke M, Morschhauser F, Lim ST, Salles G, Kloos I, de Burgat V, Becquart M, Paux G, Kraus-Berthier L, Pennaforte S, Stilgenbauer S, Walewski J, Ribrag V. A new BCL-2 Inhibitor (S55746/BCL201) as Monotherapy in Patients with Relapsed or Refractory Non-hodgkin Lymphoma: Preliminary Results of the First-in-human Study. Hematol Oncol. 2017 Jun 07;35(S5):14-17. doi: 10.1002/hon.2437_30

Drugs

EvaluationDrugModalityDoseRoute
Subject S 55746 Unknown 50 mg Oral
Subject S 55746 Unknown 1500 mg Oral