ISRCTN85966108
Completed
Phase 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 enrollmentDecember 9, 2013
Overview
- Phase
- Phase 1
- Intervention
- Not specified
- Conditions
- Not specified
- Sponsor
- Institut de Recherches Internationales Servier (France)
- Enrollment
- 50
- Status
- Completed
- Last Updated
- 7 years ago
Overview
Brief Summary
No summary available.
Investigators
Eligibility Criteria
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
Outcomes
Primary Outcomes
Not specified
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