Oral administration of S 78454 in combination with cisplatin in patients with advanced non-keratinising nasopharyngeal carcinoma
| ISRCTN | ISRCTN96922360 |
|---|---|
| DOI | https://doi.org/10.1186/ISRCTN96922360 |
| Protocol serial number | CL1-78454-009 |
| Sponsor | Institut de Recherches Internationales Servier (France) |
| Funder | Institut de Recherches Internationales Servier (France) |
- Submission date
- 19/04/2012
- Registration date
- 08/06/2012
- Last edited
- 18/04/2018
- Recruitment status
- No longer recruiting
- Overall study status
- Completed
- Condition category
- Cancer
Plain English summary of protocol
Not provided at time of registration and not expected to be available in the future
Contact information
Scientific
National University Cancer Institute
Department of Haematology - Oncology
5 Lower Kent Ridge Road
Main Building 1, Level 3
-
119074
Singapore
Study information
| Primary study design | Interventional |
|---|---|
| Study design | Multicentre international non-randomised non-comparative open-label phase I study |
| Secondary study design | Non randomised study |
| Study type | Participant information sheet |
| Scientific title | 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. |
| Study objectives | Establish the safety and tolerability of S 78454 given in combination with a fixed dose infusion of cisplatin in patients with advanced non-keratinising nasopharyngeal carcinoma in terms of the maximum tolerated dose (MTD) and the dose-limiting toxicities (DLTs), and establish the recommended Phase II dose (RP2D). |
| Ethics approval(s) | Ethics approval was obtained before recruitment of the first participants |
| Health condition(s) or problem(s) studied | 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 |
| Intervention type | Drug |
| Phase | Phase I |
| Drug / device / biological / vaccine name(s) | Cisplatin |
| Primary outcome measure(s) |
1. MTD and DLTs of oral S 78454 capsules with a fixed dose infusion of cisplatin |
| Key secondary outcome measure(s) |
1. Safety profile (adverse events, laboratory tests, physical exam, ECOG, vital signs, ECG, clinical neurological examination, audiometric tests) |
| Completion date | 30/11/2013 |
Eligibility
| Participant type(s) | Patient |
|---|---|
| Age group | Adult |
| Sex | All |
| Target sample size at registration | 40 |
| Key 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 |
| Key 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 |
| Date of first enrolment | 01/03/2012 |
| Date of final enrolment | 30/11/2013 |
Locations
Countries of recruitment
- Singapore
- Taiwan
Study participating centre
119074
Singapore
Results and Publications
| Individual participant data (IPD) Intention to share | Yes |
|---|---|
| IPD sharing plan summary | Available on request |
| IPD sharing plan | The datasets generated during and/or analysed during the current study will be available upon request from https://clinicaltrials.servier.com if a Marketing Authorisation has been granted after 1st January 2014. |
Study outputs
| Output type | Details | Date created | Date added | Peer reviewed? | Patient-facing? |
|---|---|---|---|---|---|
| Basic results | No | No | |||
| Participant information sheet | Participant information sheet | 11/11/2025 | 11/11/2025 | No | Yes |
Editorial Notes
18/04/2018: Internal review.
28/03/2018: Publication and dissemination plan and IPD sharing statement updated.
24/01/2018: Publication plan and IPD sharing statement added.
29/11/2017: Results summary added.
17/12/2015: Sponsoring/funding responsibility for the S 78454 project was transferred from Servier, France to Pharmacyclics, USA on 23/11/2014. However, as this study has already been completed at this time, the sponsor/funder remains stated as Servier. However, in case of any questions, please contact Pharmacyclics (info@pcyc.com).
