Spots Global Cancer Trial Database for Dose-escalation Study of Oral Administration of S 55746 in Patients With Chronic Lymphocytic Leukaemia and B-Cell Non-Hodgkin Lymphoma
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Trial Identification
Brief Title: Dose-escalation Study of Oral Administration of S 55746 in Patients With Chronic Lymphocytic Leukaemia and B-Cell Non-Hodgkin Lymphoma
Official Title: Phase I Dose-escalation Study of Oral Administration of the Selective Bcl2 Inhibitor S 55746 in Patients With Refractory or Relapsed Chronic Lymphocytic Leukaemia and B-Cell Non-Hodgkin Lymphoma
Study ID: NCT02920697
Interventions
Study Description
Brief 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.
Detailed Description:
Keywords
Eligibility
Minimum Age: 18 Years
Eligible Ages: ADULT, OLDER_ADULT
Sex: ALL
Healthy Volunteers: No
Locations
The Alfred Hospital Malignant Haematology & Stem Cell Transplantation Services, Melbourne, , Australia
Hopital Claude Huriez, Lille, , France
CHU de Nantes, Nantes, , France
Centre hospitalier Lyon Sud, Pierre-Bénite, , France
Gustave Roussy, Villejuif, , France
Universitätsklinikum Carl Gustav Carus, Dresden, , Germany
Städtisches Klinikum Schwabing, Munich, , Germany
Universitätsklinikum Ulm, Ulm, , Germany
National Oncology Institute, Budapest, , Hungary
CRU Hungary Kft, Miskolc, , Hungary
Severance Hospital, Seoul, , Korea, Republic of
St. Mary's Hospital, Seoul, , Korea, Republic of
Warsaw Institute of Oncology, Warsaw, , Poland
Warsaw Medical University, Warsaw, , Poland
National Cancer Center (NCC), Singapore, , Singapore
National University Cancer Institute Singapore, Singapore, , Singapore
University College London Hospitals, London, , United Kingdom
Freeman Hospital, Newcastle, , United Kingdom
Contact Details
Name: Steven Le Gouill, M.D., Ph.D.
Affiliation: Nantes University Hospital
Role: PRINCIPAL_INVESTIGATOR
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