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

Phase 1

Completed

• Conditions: ocally advanced or metastatic digestive cancer; Cancer; Malignant neoplasms of digestive organs

• Registration Number: ISRCTN75585722
• Lead Sponsor: Institut de Recherches Internationales Servier (France)

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2013-09-24
• Study Completion: 2014-09-15
• Last Update Posted: 21 May 2018

Recruitment & Eligibility

• Status: Completed
• Sex: All
• Target Recruitment: 60

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

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

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
1. Dose-limiting toxicities (DLTs) and maximum tolerated doses (MTDs) at the end of cycle 1. Methods used: blood samples, physical examination, electrocardiogram (ECG)<br>2. Safety profile of the combination at each visit

Secondary Outcome Measures

Name	Time	Method
1. Pharmacokinetic evaluation on the cycle 1 by blood sample<br>2. Tumour response evaluation during the study by imagery<br>3. Tumour markers evaluation at each cycle by blood sample