Phase I study of S 78454 in combination with a fixed dose infusion of cisplatin in patients with advanced solid tumours
- Conditions
- Advanced solid tumoursCancer
- Registration Number
- ISRCTN85966108
- Lead Sponsor
- Institut de Recherches Internationales Servier (France)
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Completed
- Sex
- All
- Target Recruitment
- 50
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
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
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method
- Secondary Outcome Measures
Name Time Method