Long-term safety study of Abexinostat in patients with haematological malignancies who previously well tolerated Abexinostat

Long-term safety study of abexinostat (S 078454) per os given as single-agent in haematological malignancies – Extension study

Status

Active, not recruiting

Phases

Phase 1Phase 2

Study type

Interventional

Source

EU CTR

Registry ID

EUCTR2014-002251-26-BE

Enrollment

Registered

2014-08-08

Start date

2014-09-08

Completion date

Unknown

Last updated

2020-02-01

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Hodgkin's Disease (HD) , Non-Hodgkin Lymphoma (NHL) and Chronic Lymphocytic Leukaemia (CLL) MedDRA version: 17.0 Level: PT Classification code 10029547 Term: Non-Hodgkin's lymphoma System Organ Class: 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps) MedDRA version: 17.0 Level: PT Classification code 10020206 Term: Hodgkin

Interventions

Product Name: S078454 Product Code: S078454 Pharmaceutical Form: Film-coated tablet Current Sponsor code: S078454 Other descriptive name

Eligibility

Sex/Gender

All

Inclusion criteria

Inclusion criteria: - Men or women with haematological malignancies that did not progress while treated with S 078454 for at least 6 months or 2 year(s) (according to the parent study) - Radiological tumour assessment performed in the parent study within 3 months before the inclusion in the present study - Clinical and biological tumour assessment performed in the parent study within 7 days before the first S 078454 intake in the present study - Adequate re-administration criteria - ECOG performance status = 2 Are the trial subjects under 18? no Number of subjects for this age range: F.1.2 Adults (18-64 years) yes F.1.2.1 Number of subjects for this age range 23 F.1.3 Elderly (>=65 years) yes F.1.3.1 Number of subjects for this age range 27

Exclusion criteria

Exclusion criteria: - No S 078454 intake during at least 21 days, - Concomitant use of drugs known to prolong QTc interval or that may be associated with Torsades de Pointes

Design outcomes

Primary

Measure	Time frame
Main Objective: To evaluate long-term safety of S078454 in patients with haematological malignancies who previously well tolerated S078454 and have clinical benefit from long term treatment with S078454;Secondary Objective: To assess the activity profile of S078454;Primary end point(s): Safety parameters (Adverse events assessment, physical examinations, performance status, vital signs, body weight, ECG parameters, laboratory parameters); Timepoint(s) of evaluation of this end point: Physical examinations, performance status, vital signs, body weight, ECG parameters: Each 4 cycles from inclusion to the withdrawal visit Adverse events: Throughout the study from inclusion to the withdrawal visit Laboratory parameters: Each cycles from inclusion to the withdrawal visit	—

Measure

Time frame

Main Objective: To evaluate long-term safety of S078454 in patients with haematological malignancies who previously well tolerated S078454 and have clinical benefit from long term treatment with S078454;Secondary Objective: To assess the activity profile of S078454;Primary end point(s): Safety parameters (Adverse events assessment, physical examinations, performance status, vital signs, body weight, ECG parameters, laboratory parameters); Timepoint(s) of evaluation of this end point: Physical examinations, performance status, vital signs, body weight, ECG parameters: Each 4 cycles from inclusion to the withdrawal visit Adverse events: Throughout the study from inclusion to the withdrawal visit Laboratory parameters: Each cycles from inclusion to the withdrawal visit

—

Secondary

Measure	Time frame
Timepoint(s) of evaluation of this end point: Each 4 cycles from inclusion to the withdrawal visit Overall survival: Up to the end of the trial or patient death ;Secondary end point(s): Efficacy parameters (Disease response according to pathology, overall survival and progression free survival)	—

Countries

Belgium, France, Hungary, Japan, Korea, Republic of, Singapore

Contacts

Public ContactClinical Studies Department

Institut de Recherches Internationales Servier

clinicaltrials@servier.com+331 55 72 43 66

Outcome results

None listed

Source: EU CTR (via WHO ICTRP) · Data processed: Feb 4, 2026