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

Browse trials for

• Leukemia, B-Cell 129
• Lymphoma, B-Cell 1,415
• Multiple Myeloma 3,712

Leukemia, B-Cell

129 studies on the registry are indexed under Leukemia, B-Cell; 46 are open to participants now.

This study's enrollment of 65 is above the median of 40 across 112 interventional studies indexed under Leukemia, B-Cell.

Lead sponsor

Institut de Recherches Internationales Servier is the lead sponsor of 67 studies on the registry; 4 are open to participants now.

Of its 18 completed or terminated interventional studies of FDA-regulated products, 8 (44%) have results posted.

Study arms

• Experimental
  B-cell Non-Hodgkin Lymphoma (NHL) and Multiple Myeloma (MM)

  Drug: S 55746

• Experimental
  Chronic Lymphocytic Leukaemia (CLL)

  Drug: S 55746

Interventions

• DrugS 55746

  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.

Primary outcomes

1. 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

   Time frame: During cycle 1 (21 days)

2. Incidence of Adverse Events (AEs)

   Characterized by severity and seriousness of AEs, laboratory abnormalities and other safety parameters such as electrocardiogram (ECG) changes

   Time frame: From first dose until 30 days after the last dose intake

Secondary outcomes

1. Plasma concentration of S 55746

   Time frame: 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

2. The pharmacokinetic (PK) profile of S 55746: Area Under the Curve [AUC]

   Time frame: 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

3. The PK profile of S 55746: Maximal Concentration [Cmax]

   Time frame: 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

4. Apoptotic activity from blood samples

   Time frame: At Cycle 1(21 days)

5. Objective Response Rate (ORR)

   Time frame: Up to study completion (maximum of 3 years)

6. Clinical Benefit Rate (CBR)

   Time frame: Up to study completion (maximum of 3 years)

7. Duration of response

   Time frame: Up to study completion (maximum of 3 years)

8. Progression Free Survival (PFS)

   Time frame: 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)

Publications

• 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

Individual participant data

Plan to share: Yes — 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: submitted for new medicines and new indications approved after 1 January 2014 in the European Economic Area (EEA) or the United States (US). Where Servier or an affiliate are the Marketing Authorization Holders (MAH). The date of the first Marketing Authorization of the new medicine (or the new indication) in one of the EEA Member States will be considered within this scope.

Supporting information: Study protocol, Statistical analysis plan, Informed consent form, Clinical study report

Time frame: After Marketing Authorisation in EEA or US if the study is used for the approval.

Access criteria: 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.

Data sharing details ↗ · clinicaltrials.servier.com