Phase I study of S 78454 in combination with a fixed dose infusion of cisplatin in patients with advanced solid tumours
| ISRCTN | ISRCTN85966108 |
|---|---|
| DOI | https://doi.org/10.1186/ISRCTN85966108 |
| Protocol serial number | CL1-78454-008 |
| Sponsor | Institut de Recherches Internationales Servier (France) |
| Funder | Institut de Recherches Internationales Servier (France) |
- Submission date
- 04/10/2013
- Registration date
- 09/12/2013
- 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
Institut Paoli Calmettes
Oncologie Médicale
232 Boulevard Sainte Marguerite
Marseille Cedex 9
13273
France
Study information
| Primary study design | Interventional |
|---|---|
| Study design | National multicentric non-randomised open-label dose escalation Phase I study |
| Secondary study design | Randomised controlled trial |
| Scientific title | Phase I dose-escalation study of oral administration of the Histone Deacetylase (HDAC) Inhibitor S 78454 given in combination with a fixed dose infusion of Cisplatin in patients with advanced solid tumours |
| Study objectives | To establish the safety profile and the recommended Phase II dose of S 78454 in combination with a fixed dose infusion of cisplatin |
| Ethics approval(s) | Ethic approval was obtained before recruitment of the first participants |
| Health condition(s) or problem(s) studied | Advanced solid tumours |
| Intervention | 1. Capsules containing 20 mg and 100 mg of S 78454 / Oral use / Treatment duration is at the discretion of the investigator 2. Fixed dose of i.v. infusion of cisplatin at 75 mg/m² / Cisplatin administration for up to 6 cycles, S 78454 could be maintained beyond |
| Intervention type | Drug |
| Phase | Phase I |
| Drug / device / biological / vaccine name(s) | S 78454, cisplatin |
| Primary outcome measure(s) |
1. DLTs and MTDs within the cycle 1 - Methods used: blood samples (biochemistry, haematology, coagulation analysis), physical examination and vital signs assessment, urinary analysis, ECG, clinical neurological examination, audiometric test |
| Key secondary outcome measure(s) |
1. Pharmacokinetic evaluation on cycle 1 by blood sample |
| Completion date | 05/02/2014 |
Eligibility
| Participant type(s) | Patient |
|---|---|
| Age group | Adult |
| Lower age limit | 18 Years |
| Sex | All |
| Target sample size at registration | 50 |
| Key inclusion criteria | 1. Male or female patient aged > or equal to 18 years 2. Any histological confirmed diagnosis of advanced solid tumours that have relapsed or is refractory to conventional standard forms of therapy 3. Ability to swallow oral capsule(s) 4. Estimated life expectancy > 12 weeks 5. ECOG performance status < or equal to 1 6. Adequate haematological, renal and hepatic functions |
| Key exclusion criteria | 1. Major surgery within previous 4 weeks 2. Chemotherapy within previous 3 weeks (6 weeks for nitroso-ureas) 3. Hormonotherapy within 2 weeks (6 weeks for bicalutamide) 4. Any other prior therapy directed at the solid tumours within 3 weeks 5. Radiotherapy within previous 4 weeks (except for palliative radiotherapy at localised lesions) 6. Cumulative radiation therapy involving > 25 % of total bone marrow 7. Pregnant or breast-feeding women, women of childbearing potential or men without effective contraception 8. Peripheral Neuropathy > grade 1 9. Hearing impairment/tinnitus > grade 2 10. Prior treatment with cisplatin reaching a cumulative dose of 300 mg/m² 11. Concomitant uncontrolled infection or severe systemic disease 12. Symptomatic or progressive brain metastasis 13. Patients with pre-existing gastrointestinal disorders 14. Concurrent therapeutic anticoagulation by AVK 15. Patient with impaired cardiac function 16. Patients with pre-existing gastro-intestinal disorders 17. Uncontrolled diabetes mellitus |
| Date of first enrolment | 05/04/2012 |
| Date of final enrolment | 05/02/2014 |
Locations
Countries of recruitment
- France
Study participating centre
13273
France
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 |
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).
