Phase I study of S 78454 in combination with a fixed dose infusion of cisplatin in patients with advanced solid tumours

Phase I dose-escalation study of oral administration of the Histone Deacetylase (HDAC) Inhibitor S 78454 given in combination with a fixed dose infusion of Cisplatin in patients with advanced solid tumours

Status

Active, not recruiting

Phases

Phase 1

Study type

Interventional

Source

ISRCTN

Registry ID

ISRCTN85966108

Enrollment

Registered

2013-12-09

Start date

2012-04-05

Completion date

Unknown

Last updated

2018-05-21

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

Conditions

Advanced solid tumours Cancer

Interventions

1. Capsules containing 20 mg and 100 mg of S 78454 / Oral use / Treatment duration is at the discretion of the investigator 2. Fixed dose of i.v. infusion of cisplatin at 75 mg/m² / Cisplatin administ

Eligibility

Sex/Gender

All

Inclusion criteria

Inclusion criteria: 1. Male or female patient aged > or equal to 18 years 2. Any histological confirmed diagnosis of advanced solid tumours that have relapsed or is refractory to conventional standard forms of therapy 3. Ability to swallow oral capsule(s) 4. Estimated life expectancy > 12 weeks 5. ECOG performance status < or equal to 1 6. Adequate haematological, renal and hepatic functions

Exclusion criteria

Exclusion criteria: 1. Major surgery within previous 4 weeks 2. Chemotherapy within previous 3 weeks (6 weeks for nitroso-ureas) 3. Hormonotherapy within 2 weeks (6 weeks for bicalutamide) 4. Any other prior therapy directed at the solid tumours within 3 weeks 5. Radiotherapy within previous 4 weeks (except for palliative radiotherapy at localised lesions) 6. Cumulative radiation therapy involving > 25 % of total bone marrow 7. Pregnant or breast-feeding women, women of childbearing potential or men without effective contraception 8. Peripheral Neuropathy > grade 1 9. Hearing impairment/tinnitus > grade 2 10. Prior treatment with cisplatin reaching a cumulative dose of 300 mg/m² 11. Concomitant uncontrolled infection or severe systemic disease 12. Symptomatic or progressive brain metastasis 13. Patients with pre-existing gastrointestinal disorders 14. Concurrent therapeutic anticoagulation by AVK 15. Patient with impaired cardiac function 16. Patients with pre-existing gastro-intestinal disorders 17. Uncontrolled diabetes mellitus

Design outcomes

Primary

Measure	Time frame
1. DLTs and MTDs within the cycle 1 - Methods used: blood samples (biochemistry, haematology, coagulation analysis), physical examination and vital signs assessment, urinary analysis, ECG, clinical neurological examination, audiometric test 2. Safety profile of the combination at each visit	—

Secondary

Measure	Time frame
1. Pharmacokinetic evaluation on cycle 1 by blood sample 2. Circulating Tumour Cells measurements every 2 cycles by blood sample 3. Tumour response evaluation every 2 cycles according to RECIST criteria	—

Countries

France

Outcome results

None listed

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