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

Phase 1

Completed

• Conditions: Advanced non-keratinising nasopharyngeal carcinoma; Cancer; Carcinoma in situ of oral cavity and pharynx

• Registration Number: ISRCTN96922360
• Lead Sponsor: Institut de Recherches Internationales Servier (France)

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2012-06-08
• Study Completion: 2013-11-30
• Last Update Posted: 21 May 2018

Recruitment & Eligibility

• Status: Completed
• Sex: All
• Target Recruitment: 40

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

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

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
1. MTD and DLTs of oral S 78454 capsules with a fixed dose infusion of cisplatin<br>2. Establish the recommended phase II dose

Secondary Outcome Measures

Name	Time	Method
1. Safety profile (adverse events, laboratory tests, physical exam, ECOG, vital signs, ECG, clinical neurological examination, audiometric tests)<br>2. To determine pharmacokinetic (PK) profile<br>3. Measure Tumour response according to revised Response Evaluation Criteria In Solid Tumors (RECIST)_ and plasma Epstein-Barr Virus (EBV) DNA levels