ISRCTN55052510
Completed
Phase 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 enrollmentSeptember 24, 2013
Overview
- Phase
- Phase 1
- Intervention
- Not specified
- Conditions
- Solid tumours
- Sponsor
- Institut de Recherches Internationales Servier (France)
- Enrollment
- 36
- Status
- Completed
- Last Updated
- 7 years ago
Overview
Brief Summary
No summary available.
Investigators
Eligibility Criteria
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
Outcomes
Primary Outcomes
Not specified
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