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

Status

Active, not recruiting

Phases

Phase 1Phase 2

Study type

Interventional

Source

EU CTR

Registry ID

EUCTR2009-013691-47-FR

Enrollment

Unknown

Registered

2009-10-19

Start date

2009-12-08

Completion date

Unknown

Last updated

2017-02-06

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: 12.0 Level: LLT Classification code 10020206 Term: Hodgkin's disease MedDRA version: 12.0 Level: LLT Classification code 10029547 Term: Non-Hodgkin's lymphoma MedDRA version: 12.0 Level: LLT Classification code 10008993 Term: Chronic lymphoid leukaemia

Interventions

Product Name: S78454 Product Code: S78454 Pharmaceutical Form: Capsule, hard Current Sponsor code: S78454 Concentration unit: mg milligram(s) Concentration type: equal Concentration number: 20-mg Pro

Eligibility

Sex/Gender

All

Inclusion criteria

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

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.

Design outcomes

Primary

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

Measure

Time frame

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

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Countries

Belgium, France, Hungary, United Kingdom

Outcome results

None listed

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