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

NCT02920697 · Status: COMPLETED · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 65

Last updated 2024-07-25

No results posted yet for this study

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

  • Chronic Lymphocytic Leukaemia (CLL)
  • B-Cell Non-Hodgkin Lymphoma (NHL)
  • Multiple Myeloma (MM)

Interventions

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.

Sponsors & Collaborators

  • ADIR, a Servier Group company

    collaborator INDUSTRY

  • Institut de Recherches Internationales Servier

    lead OTHER

Principal Investigators

  • Steven Le Gouill, M.D., Ph.D. · Nantes University Hospital

Study Design

Allocation
NON_RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2014-03-31
Primary Completion
2018-10-22
Completion
2018-10-22

Countries

  • Australia
  • France
  • Germany
  • Hungary
  • Poland
  • Singapore
  • South Korea
  • United Kingdom

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT02920697 on ClinicalTrials.gov