Advanced non-keratinising nasopharyngeal carcinoma Cancer Carcinoma in situ of oral cavity and pharynx
Conditions
Interventions
S 78454 capsules 80 mg twice a day (b.i.d.) to 140mg b.i.d.
Cisplatin / 1 infusion per cycle / 75mg/m² maximum
1. At least 2 cycles of combination treatment.
2. Cisplatin limited to 6 cycles
3. S7
Sponsors
Institut de Recherches Internationales Servier (France)
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1. Male or female patients aged =21 (Singapore) =20 (Taiwan) 2. Histologically documented, measurable or evaluable advanced non-keratinising nasopharyngeal carcinoma, that has relapsed or is refractory to conventional, standard forms of therapy. 3. Ability to swallow oral capsule(s) without difficulty 4. Eastern Cooperative Oncology Group (ECOG) performance status = 1 5. Estimated life expectancy > 12 weeks 6. Adequate haematological, renal and hepatic functions-Serum albumin 30 g/L 7. Written informed consent
Exclusion criteria
Exclusion criteria: 1. Pregnant or breastfeeding women, women of childbearing potential or men without effective contraception 2. Involvement in another clinical trial at the same time or within 4 weeks prior to inclusion, or patient already enrolled in the study 3. Major surgery within previous 4 weeks 4. Chemotherapy within previous 3 weeks (6 weeks in case of nitroso-ureas) 5. Biologic/target therapy or immunologic agents within previous 3 weeks 6. Radiotherapy within previous 4 weeks (except for palliative radiotherapy at localised lesions) 7. Abnormal thyroid function (defined as thyroid-stimulating hormone or free T4) except for patients with hypothyroidism diagnosed prior to study entry and stable on thyroid replacement 8. Concurrent therapeutic anticoagulation by anti-vitamin K (AVK) 9. Uncontrolled diabetes mellitus 10. Concomitant uncontrolled infection or severe systemic disease 11. Symptomatic or progressive brain metastasis 12. Patients with pre-existing gastrointestinal disorders 13. Patient with impaired cardiac function 14. Prior exposure to any Histone deacetylase inhibitors (HDACi) 15. Known organ dysfunction 16. Peripheral neuropathy > grade 1 17. Hearing impairment/tinnitus > grade 2 18. Known hypersensitivity to cisplatin
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| 1. MTD and DLTs of oral S 78454 capsules with a fixed dose infusion of cisplatin 2. Establish the recommended phase II dose | — |
Secondary
| Measure | Time frame |
|---|---|
| 1. Safety profile (adverse events, laboratory tests, physical exam, ECOG, vital signs, ECG, clinical neurological examination, audiometric tests) 2. To determine pharmacokinetic (PK) profile 3. Measure Tumour response according to revised Response Evaluation Criteria In Solid Tumors (RECIST)_ and plasma Epstein-Barr Virus (EBV) DNA levels | — |
Countries
Singapore, Taiwan
Outcome results
None listed