Trials / Completed
CompletedNCT02920697
Dose-escalation Study of Oral Administration of S 55746 in Patients With Chronic Lymphocytic Leukaemia and B-Cell Non-Hodgkin Lymphoma
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
- Status
- Completed
- Phase
- Phase 1
- Study type
- Interventional
- Enrollment
- 65 (actual)
- Sponsor
- Institut de Recherches Internationales Servier · Academic / Other
- Sex
- All
- Age
- 18 Years
- Healthy volunteers
- Not accepted
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.
Conditions
Interventions
| Type | Name | Description |
|---|---|---|
| DRUG | S 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. |
Timeline
- Start date
- 2014-03-01
- Primary completion
- 2018-10-22
- Completion
- 2018-10-22
- First posted
- 2016-09-30
- Last updated
- 2024-07-25
Locations
18 sites across 8 countries: Australia, France, Germany, Hungary, Poland, Singapore, South Korea, United Kingdom
Source: ClinicalTrials.gov record NCT02920697. Inclusion in this directory is not an endorsement.