Additional identifiers
EudraCT/CTIS number
IRAS number
ClinicalTrials.gov number
Protocol/serial number
CL1-78454-008
Study information
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
Acronym
Study hypothesis
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
Study design
National multicentric non-randomised open-label dose escalation Phase I study
Primary study design
Interventional
Secondary study design
Randomised controlled trial
Study setting(s)
Hospital
Study type
Treatment
Patient information sheet
Condition
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
Pharmaceutical study type(s)
Phase
Phase I
Drug/device/biological/vaccine name(s)
S 78454, cisplatin
Primary outcome measure
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
2. Safety profile of the combination at each visit
Secondary outcome measures
1. Pharmacokinetic evaluation on cycle 1 by blood sample
2. Circulating Tumour Cells measurements every 2 cycles by blood sample
3. Tumour response evaluation every 2 cycles according to RECIST criteria
Overall study start date
05/04/2012
Overall study end date
05/02/2014
Reason abandoned (if study stopped)
Eligibility
Participant 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
Participant type(s)
Patient
Age group
Adult
Lower age limit
18 Years
Sex
Both
Target number of participants
Up to 50 patients
Participant 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
Recruitment start date
05/04/2012
Recruitment end date
05/02/2014
Locations
Countries of recruitment
France
Study participating centre
Institut Paoli Calmettes
Marseille Cedex 9
13273
France
Sponsor information
Organisation
Institut de Recherches Internationales Servier (France)
Sponsor details
50 rue Carnot
Suresnes
92284
France
Sponsor type
Industry
Website
ROR
Funders
Funder type
Industry
Funder name
Institut de Recherches Internationales Servier (France)
Alternative name(s)
Funding Body Type
Funding Body Subtype
Location
Results and Publications
Publication and dissemination plan
Publication plan:
Summary results are published in https://clinicaltrials.servier.com.
Intention to publish date
Individual participant data (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.
IPD sharing plan summary
Available on request
Study outputs
| Output type | Details | Date created | Date added | Peer reviewed? | Patient-facing? |
|---|---|---|---|---|---|
| Basic results | No | No |