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| ID | Type | Description | Link |
|---|---|---|---|
| 2013-003779-36 | EudraCT Number | ||
| ISRCTN04804337 | Registry Identifier | ISRCTN |
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| Name | Class |
|---|---|
| ADIR, a Servier Group company | INDUSTRY |
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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| B-cell Non-Hodgkin Lymphoma (NHL) and Multiple Myeloma (MM) | Experimental |
| |
| Chronic Lymphocytic Leukaemia (CLL) | Experimental |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| S 55746 | Drug | S 55746, per os administration, from 50 to 1500 mg, once a day during a 21-day cycle. Participants will receive 21-day cycles of treatment until a discontinuation criterion is met. |
| Measure | Description | Time Frame |
|---|---|---|
| Maximum Tolerated Dose (MTD) | The MTD is the highest drug dosage that is unlikely (<25% posterior probability) to cause DLT in more than 33% of the treated patients in the first cycle of S 55746 treatment | During cycle 1 (21 days) |
| Incidence of Adverse Events (AEs) | Characterized by severity and seriousness of AEs, laboratory abnormalities and other safety parameters such as electrocardiogram (ECG) changes | From first dose until 30 days after the last dose intake |
| Measure | Description | Time Frame |
|---|---|---|
| Plasma concentration of S 55746 | Pre-dose on Cycle 1 Day 1 (C1D1), C1D2, C1D3, C1D4, C1D5, C1D8, C1D9, C2D1 ; 0.5, 1, 1.5, 2, 3, 4, 6, 8, 10-12 hours post-dose on C1D1, C1D8 | |
| The pharmacokinetic (PK) profile of S 55746: Area Under the Curve [AUC] | Pre-dose on Cycle 1 Day 1 (C1D1), C1D2, C1D3, C1D4, C1D5, C1D8, C1D9, C2D1 ; 0.5, 1, 1.5, 2, 3, 4, 6, 8, 10-12 hours post-dose on C1D1, C1D8 |
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Inclusion Criteria:
Additional inclusion criteria for food interaction cohort:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Steven Le Gouill, M.D., Ph.D. | Nantes University Hospital | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| The Alfred Hospital Malignant Haematology & Stem Cell Transplantation Services | Melbourne | 3004 | Australia | |||
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 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 |
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| ID | Type | URL | Comment |
|---|---|---|---|
| Individual Participant Data Set | View IPD |
Researchers can ask for a study protocol, patient-level and/or study-level clinical trial data including clinical study reports (CSRs).
They can ask all interventional clinical studies:
After Marketing Authorisation in EEA or US if the study is used for the approval.
Researchers should register on Servier Data Portal and fill in the research proposal form. This form in four parts should be fully documented. The Research Proposal Form will not be reviewed until all mandatory fields are completed.
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| The PK profile of S 55746: Maximal Concentration [Cmax] | Pre-dose on Cycle 1 Day 1 (C1D1), C1D2, C1D3, C1D4, C1D5, C1D8, C1D9, C2D1 ; 0.5, 1, 1.5, 2, 3, 4, 6, 8, 10-12 hours post-dose on C1D1, C1D8 |
| Apoptotic activity from blood samples | At Cycle 1(21 days) |
| Objective Response Rate (ORR) | Up to study completion (maximum of 3 years) |
| Clinical Benefit Rate (CBR) | Up to study completion (maximum of 3 years) |
| Duration of response | Up to study completion (maximum of 3 years) |
| Progression Free Survival (PFS) | From date of inclusion until the date of progression or date of death, whichever occurs first, assessed up to study completion (maximum of 3 years) |
| 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 |
| Warsaw Institute of Oncology | Warsaw | Poland |
| Warsaw Medical University | Warsaw | Poland |
| National Cancer Center (NCC) | Singapore | Singapore |
| National University Cancer Institute Singapore | Singapore | Singapore |
| Severance Hospital | Seoul | South Korea |
| St. Mary's Hospital | Seoul | South Korea |
| University College London Hospitals | London | United Kingdom |
| Freeman Hospital | Newcastle | United Kingdom |
| Study Protocol | View IPD |
| Statistical Analysis Plan | View IPD |
| Informed Consent Form | View IPD |
| study-level clinical trial data | View IPD |
| Clinical Study Report | View IPD |
| ID | Term |
|---|---|
| D015448 | Leukemia, B-Cell |
| D016393 | Lymphoma, B-Cell |
| D009101 | Multiple Myeloma |
| ID | Term |
|---|---|
| D007945 | Leukemia, Lymphoid |
| D007938 | Leukemia |
| D009370 | Neoplasms by Histologic Type |
| D009369 | Neoplasms |
| D006402 | Hematologic Diseases |
| D006425 | Hemic and Lymphatic Diseases |
| D008232 | Lymphoproliferative Disorders |
| D008206 | Lymphatic Diseases |
| D007160 | Immunoproliferative Disorders |
| D007154 | Immune System Diseases |
| D008228 | Lymphoma, Non-Hodgkin |
| D008223 | Lymphoma |
| D054219 | Neoplasms, Plasma Cell |
| D020141 | Hemostatic Disorders |
| D014652 | Vascular Diseases |
| D002318 | Cardiovascular Diseases |
| D010265 | Paraproteinemias |
| D001796 | Blood Protein Disorders |
| D006474 | Hemorrhagic Disorders |
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