Phase I study of S 78454 in combination with FOLFOX in patients with digestive cancer
| ISRCTN | ISRCTN75585722 |
|---|---|
| DOI | https://doi.org/10.1186/ISRCTN75585722 |
| Secondary identifying numbers | CL1-78454-006 |
- 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
Prospectively registered
Protocol
Statistical analysis plan
Results
Individual participant data
Plain English summary of protocol
Not provided at time of registration and not expected to be available in the future
Contact information
Prof Philippe Rougier
Scientific
Scientific
Hôpital Européen George Pompidou
20 rue Leblanc
Paris
75015
France
Study information
| Study design | International multicentric non-randomised open dose escalation phase I study |
|---|---|
| Primary study design | Interventional |
| Secondary study design | Non randomised study |
| Study setting(s) | Hospital |
| Study type | Treatment |
| Participant information sheet | Not available in web format, please use the contact details to request a patient 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 |
| Pharmaceutical study type(s) | |
| Phase | Phase I |
| Drug / device / biological / vaccine name(s) | S 78454, FOLFOX |
| Primary outcome measure | 1. Dose-limiting toxicities (DLTs) and maximum tolerated doses (MTDs) at the end of cycle 1. Methods used: blood samples, physical examination, electrocardiogram (ECG) 2. Safety profile of the combination at each visit |
| Secondary outcome measures | 1. Pharmacokinetic evaluation on the cycle 1 by blood sample 2. Tumour response evaluation during the study by imagery 3. Tumour markers evaluation at each cycle by blood sample |
| Overall study start date | 15/09/2011 |
| Completion date | 15/09/2014 |
Eligibility
| Participant type(s) | Patient |
|---|---|
| Age group | Adult |
| Lower age limit | 18 Years |
| Sex | Both |
| Target number of participants | 60 patients |
| 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
Hôpital Européen George Pompidou
Paris
75015
France
75015
France
Sponsor information
Institut de Recherches Internationales Servier (France)
Industry
Industry
50 rue Carnot
Suresnes
92284
France
| Website | http://www.servier.com/ |
|---|---|
"ROR" |
https://ror.org/034e7c066 |
Funders
Funder type
Industry
Institut de Recherches Internationales Servier (France)
No information available
Results and Publications
| Intention to publish date | |
|---|---|
| Individual participant data (IPD) Intention to share | Yes |
| IPD sharing plan summary | Available on request |
| Publication and dissemination plan | Publication plan: Summary results are published in https://clinicaltrials.servier.com. |
| 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 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).
