Phase I/II dose-escalation study of oral administration of the Pan-Histone Deacetylase (HDAC) Inhibitor S 78454 in Hodgkin’s Disease, non-Hodgkin Lymphoma and Chronic Lymphocytic Leukaemia

Phase 1

Conditions: Hodgkin's disease (HD) , non-Hodgkin lymphoma (NHL) and chronic lymphocytic Leukaemia (CLL)
MedDRA version: 12.0Level: LLTClassification code 10020206Term: Hodgkin's disease
MedDRA version: 12.0Level: LLTClassification code 10029547Term: Non-Hodgkin's lymphoma
MedDRA version: 12.0Level: LLTClassification code 10008993Term: Chronic lymphoid leukaemia

Registration Number: EUCTR2009-013691-47-FR

Lead Sponsor: Institut de Recherches Internationales Servier

Brief Summary: Not available

Detailed Description: Not available

Recruitment & Eligibility

Status: ot Recruiting

Sex: All

Target Recruitment: Not specified

Inclusion Criteria

- HD or NHL that has relapsed or is refractory to conventional, standard form of therapy.
- CLL that has relapsed or is refractory to conventional, standard form of therapy.
- Ability to swallow oral capsule(s) without difficulty.
- Estimated life expectancy > 12 weeks.
- ECOG performance status = 1.
- Adequate haematological, renal and hepatic functions.
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
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range

Exclusion Criteria

- Allogeneic bone marrow transplant.
- Major surgery within previous 4 weeks.
- Concurrent therapeutic anticoagulation by AVK (Phase I part only).
- Corticosteroids > 20 mg prednisone equivalent per day.
- Immunotherapy, chemotherapy (nitrosoureas within 6 weeks) or radiotherapy within previous 4 weeks.
- Patients treated by valproic acid.
- Any other previous (in the last 5 years) or concurrent cancer, other than resected non melanoma skin cancer or cancer in situ of the uterine cervix.
- Risk factors for, or use of drugs known to prolong QTc interval or that may be associated with Torsades de Pointes.

Study & Design

Study Type: Interventional clinical trial of medicinal product

Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Main Objective: Phase I part:<br>- To assess the MTD and the dose-limiting toxicities (DLTs).<br><br>Phase II part:<br>- To assess the objective response rate at the recommended dose defined in the phase I part.<br>- To assess the safety and tolerability.;Secondary Objective: Phase I part:<br>- To determine the PK and PD profiles.<br>- To measure tumour response.<br><br>Phase II part:<br>- To assess the activity profile.<br>- To determine the PK and PD profiles.;Primary end point(s): - DLTs and MTD.<br>- Objective response rate.

Secondary Outcome Measures