Phase I dose escalation study of oral administration of Pan-Histone Deacetylase (HDAC) inhibitor S 78454 given in combination with a fixed dose infusion of cisplatin in patients with advanced non-keratinising nasopharyngeal carcinoma.

Institut de Recherches Internationales Servier (France)0 sites40 target enrollmentJune 8, 2012

Overview

No summary available.

Registry

who.int

Start Date

June 8, 2012

End Date

November 30, 2013

Last Updated

7 years ago

Study Type

Interventional

Sex

All

Sponsor

Institut de Recherches Internationales Servier (France)

•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

•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