Phase I study of S 78454 in combination with FOLFOX in patients with digestive cancer
| ISRCTN | ISRCTN75585722 |
|---|---|
| DOI | https://doi.org/10.1186/ISRCTN75585722 |
| Protocol serial number | CL1-78454-006 |
| Sponsor | Institut de Recherches Internationales Servier (France) |
| Funder | Institut de Recherches Internationales Servier (France) |
- Submission date
- 02/09/2013
- Registration date
- 24/09/2013
- 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
Hôpital Européen George Pompidou
20 rue Leblanc
Paris
75015
France
Study information
| Primary study design | Interventional |
|---|---|
| Study design | International multicentric non-randomised open dose escalation phase I study |
| Secondary study design | Non randomised study |
| Study type | Participant information sheet |
| Scientific title | Phase I dose-escalation study of S 78454 (HDACi) p.o. in combination with FOLFOX in patients with locally advanced or metastatic digestive cancer |
| Study objectives | To establish the safety profile and the recommended Phase II dose of S 78454 in combination with FOLFOX (folinic acid, fluorouracil, oxaliplatin). |
| Ethics approval(s) | Ethics approval was obtained before recruitment of the first participants |
| Health condition(s) or problem(s) studied | Locally advanced or metastatic digestive cancer |
| Intervention | 1. Capsules containing 20 mg and 100 mg of S 78454 / Oral use / Treatment duration is at the discretion of the investigator 2. Concomitant intravenous (i.v.) infusion of FOLFOX / Treatment duration is at the discretion of the investigator No control group is involved |
| Intervention type | Drug |
| Phase | Phase I |
| Drug / device / biological / vaccine name(s) | S 78454, FOLFOX |
| Primary outcome measure(s) |
1. Dose-limiting toxicities (DLTs) and maximum tolerated doses (MTDs) at the end of cycle 1. Methods used: blood samples, physical examination, electrocardiogram (ECG) |
| Key secondary outcome measure(s) |
1. Pharmacokinetic evaluation on the cycle 1 by blood sample |
| Completion date | 15/09/2014 |
Eligibility
| Participant type(s) | Patient |
|---|---|
| Age group | Adult |
| Lower age limit | 18 Years |
| Sex | All |
| Target sample size at registration | 60 |
| Key inclusion criteria | 1. Male or female patient aged > or equal to 18 years 2. Any histological confirmed measurable or evaluable metastatic colorectal cancer (mCRC) or locally advanced or metastatic gastric or pancreatic cancer with a true primary resistance to FOLFOX 3. Ability to swallow oral capsule(s) 4. Ability to receive FOLFOX regimen 5. Estimated life expectancy > 12 weeks 6. Eastern Cooperative Oncology Group (ECOG) performance status < or equal to 1 7. Body mass index (BMI) > or equal to 20 8. Adequate haematological, renal and hepatic functions |
| Key exclusion criteria | 1. Major surgery within previous 4 weeks 2. Chemotherapy (other than FOLFOX) within previous 3 weeks 3. Small molecules treatment (tyrosine kinase inhibitor) or antibodies within previous 1 week 4. Radiotherapy within previous 4 weeks (except for palliative radiotherapy at localised lesions) 5. Pregnant or breastfeeding women, women of childbearing potential or men without effective contraception 6. Prior exposure to any histone deacetylase inhibitors (HDACi) 7. Neuropathy > grade 1 8. Unresolved diarrhea > grade 1 9. Concomitant uncontrolled severe systemic disease 10. Patient with impaired cardiac function |
| Date of first enrolment | 15/09/2011 |
| Date of final enrolment | 15/09/2014 |
Locations
Countries of recruitment
- Belgium
- France
- Italy
Study participating centre
75015
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 | |||
| 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 had 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).
