ISRCTN55052510CompletedPhase 1
Phase I dose-escalation study of oral administration of S 78454 given with a fixed dose infusion of doxorubicin administered weekly 3 out of 4 weeks in patients with solid tumour
Institut de Recherches Internationales Servier (France)0 sites36 target enrollmentStarted: September 24, 2013Last updated:
Conditions
Trial Snapshot
- Phase
- Phase 1
- Status
- Completed
- Sponsor
- Enrollment
- 36
Study Overview
Brief Summary
No summary available.
Study Design
- Study Type
- Interventional
Eligibility Criteria
- Sex
- All
Inclusion Criteria
- •1. Solid tumour, with measurable or evaluable disease, that has relapsed or is refractory to conventional, standard forms of therapy
- •2. Ability to swallow oral capsule(s) without difficulty
- •3. Estimated life expectancy > 12 weeks
- •4. Eastern Cooperative Oncology Group (ECOG) performance status < or equal to 1
- •5. Adequate haematological, renal and hepatic functions
Exclusion Criteria
- •1. Major surgery within previous 4 weeks
- •2. Chemotherapy within previous 3 weeks (6 weeks in case of nitrosoureas)
- •3. Radiotherapy within previous 4 weeks (except for palliative radiotherapy at localised lesions)
- •4. Immunotherapy or hormonotherapy within previous 2 weeks, except stable oral glucocorticoid and mineralocorticoid replacement for adrenal insufficiency, or oral contraceptives or hormonal replacement therapy
- •5. Risk factors for, or use of drugs known to prolong QTc interval and that may be associated with Torsades de Pointes
- •6. Patients treated by valproic acid within previous 5 days
- •7. Phenytoin (and by extension fosphenytoin) within previous 3 weeks
Investigators
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