Condition category
Cancer
Date applied
04/10/2013
Date assigned
09/12/2013
Last edited
17/12/2015
Prospective/Retrospective
Retrospectively registered
Overall trial status
Completed
Recruitment status
No longer recruiting

Plain English Summary

Not provided at time of registration and not expected to be available in the future

Trial website

Contact information

Type

Scientific

Primary contact

Dr Anthony Goncalves

ORCID ID

Contact details

Institut Paoli Calmettes
Oncologie Médicale
232 Boulevard Sainte Marguerite
Marseille Cedex 9
13273
France

Additional identifiers

EudraCT 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

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

Trial setting

Hospitals

Trial 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

Phase

Phase I

Drug names

S 78454, cisplatin

Primary outcome measures

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 trial start date

05/04/2012

Overall trial end date

05/02/2014

Reason abandoned

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

Patient

Age group

Adult

Gender

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

Trial 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

http://www.servier.com/

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

Not provided at time of registration

Intention to publish date

Participant level data

Not provided at time of registration

Results - basic reporting

Publication summary

Publication citations

Additional files

Editorial Notes

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).