ISRCTN85966108CompletedPhase 1
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
Institut de Recherches Internationales Servier (France)0 sites50 target enrollmentStarted: December 9, 2013Last updated:
Conditions
Trial Snapshot
- Phase
- Phase 1
- Status
- Completed
- Sponsor
- Enrollment
- 50
Study Overview
Brief Summary
No summary available.
Study Design
- Study Type
- Interventional
Eligibility Criteria
- Sex
- All
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
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
Investigators
Similar Trials
Completed
Phase 1
Phase I study of oral administration of S 78454 in association with doxorubicin in patients with solid tumourSolid tumoursMalignant neoplasm, unspecifiedCancerISRCTN55052510Institut de Recherches Internationales Servier (France)36
Completed
Phase 1
Phase I dose-escalation study of oral administration of S55746 in patients with B-Cell Non-Hodgkin LymphomaChronic Lymphocytic Leukaemia (CLL) and B-Cell Non-Hodgkin Lymphoma (NHL) including Follicular Lymphoma (FL) , Mantle Cell Lymphoma (MCL), Diffuse Large B-Cell Lymphoma, Small Lymphocytic Lymphoma, Marginal Zone Lymphoma and and Multiple myeloma (MM)Chronic Lymphocytic Leukaemia (CLL) and B-Cell Non-Hodgkin Lymphoma (NHL) including Follicular Lymphoma (FL) , Mantle Cell Lymphoma (MCL), Diffuse Large B-Cell Lymphoma, Small Lymphocytic Lymphoma, Marginal Zone Lymphoma, Multiple myeloma (MM)CancerISRCTN04804337Institut de Recherches Internationales Servier (France)120
Completed
Phase 1
Phase I study of S 78454 with tamoxifen 20 mg in patients with breast cancerAdvanced breast cancerCancerISRCTN25889030Pharmacyclics LLC (USA)40
Completed
Phase 1
Oral administration of S 78454 in combination with cisplatin in patients with advanced non-keratinising nasopharyngeal carcinomaAdvanced non-keratinising nasopharyngeal carcinomaCarcinoma in situ of oral cavity and pharynxCancerISRCTN96922360Institut de Recherches Internationales Servier (France)40
Active, not recruiting
Phase 1
Phase I/II dose-escalation study of oral administration of the Pan-Histone Deacetylase (HDAC) Inhibitor S 78454 in Hodgkin’s Disease, non-Hodgkin Lymphoma and Chronic Lymphocytic LeukaemiaHodgkin's disease (HD) , non-Hodgkin lymphoma (NHL) and chronic lymphocytic Leukaemia (CLL)MedDRA version: 12.0Level: LLTClassification code 10020206Term: Hodgkin's diseaseMedDRA version: 12.0Level: LLTClassification code 10029547Term: Non-Hodgkin's lymphomaMedDRA version: 12.0Level: LLTClassification code 10008993Term: Chronic lymphoid leukaemiaEUCTR2009-013691-47-FRInstitut de Recherches Internationales Servier