Phase I study of S 78454 in combination with FOLFOX in patients with digestive cancer

Phase I dose-escalation study of S 78454 (HDACi) p.o. in combination with FOLFOX in patients with locally advanced or metastatic digestive cancer

Status

Active, not recruiting

Phases

Phase 1

Study type

Interventional

Source

ISRCTN

Registry ID

ISRCTN75585722

Enrollment

Registered

2013-09-24

Start date

2011-09-15

Completion date

Unknown

Last updated

2018-05-21

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Locally advanced or metastatic digestive cancer Cancer Malignant neoplasms of digestive organs

Interventions

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

Eligibility

Sex/Gender

All

Inclusion criteria

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 20 8. Adequate haematological, renal and hepatic functions

Exclusion criteria

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

Design outcomes

Primary

Measure	Time frame
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

Measure	Time frame
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	—

Countries

Belgium, France, Italy

Outcome results

None listed

Source: ISRCTN (via WHO ICTRP) · Data processed: Feb 4, 2026