Oral administration of S 78454 in combination with cisplatin in patients with advanced non-keratinising nasopharyngeal carcinoma

INTERVENTION: 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. S78454 as long as the disease does not progress and treatment sufficiently tolerated or consent withdrawal CONDITION: Advanced non‐keratinising nasopharyngeal carcinoma ; Cancer ; Carcinoma in situ of oral cavity and pharynx PRIMARY OUTCOME: 1. MTD and DLTs of oral S 78454 capsules with a fixed dose infusion of cisplatin; 2. Establish the recommended phase II dose SECONDARY OUTCOME: 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 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