Advanced solid tumours Cancer
Conditions
Interventions
Capsules containing 7.5 mg and 30 mg of S 49076 administered orally. Treatment duration is at the discretion of the investigator
Sponsors
Institut de Recherches Internationales Servier (France)
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1. Male or female patient aged 18 years or older 2. Advanced solid tumour that has relapsed or is refractory to standard therapy or for which no effective standard therapy is available 3. Ability to swallow oral capsule(s) 4. Estimated life expectancy of more than 12 weeks 5. ECOG performance status less than or equal to 1 6. Adequate haematological, renal and hepatic functions
Exclusion criteria
Exclusion criteria: 1. Major surgery within 4 weeks prior to the first day of the study drug administration 2. Chemotherapy within 3 weeks prior to the first day of the study drug administration (6 weeks in the case of treatment with nitroso-ureas) 3. Any other prior therapy involving an agent directed to the solid tumours within five times of the half-life of said agent but not less than 3 weeks prior to the first day of study drug administration 4. Hormonal therapy directed to the solid tumours within 2 weeks prior to the first day of study drug administration (6 weeks in the case of treatment with bicalutamide), except in the case of LHRH agonist therapy for prostate cancer which is permitted. 5. Radiotherapy within 4 weeks prior to the first day of the study drug administration (within 1 week in the case of palliative radiotherapy at localised lesions) 6. Cumulative radiation therapy involving more than 25% of the total bone marrow 7. Concomitant uncontrolled infection or severe systemic disease (at the discretion of the investigator) 8. Known organ dysfunction which would either compromise the patient's safety or interfere with the evaluation of the study drug safety 9. Patients with impaired cardiac function
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| 1. Dose limiting toxicity (DLT) and maximum tolerated dose (MTD) at the end of the cycle 1, measured by AE 2. Safety profile at each visit, measured by AE monitoring | — |
Secondary
| Measure | Time frame |
|---|---|
| 1. Pharmacokinetic evaluation within cycles 1 and 2: blood samples 2. Pharmacodynamic evaluation at each cycle: blood samples 3. Tumour response evaluation every two cycles: imagery | — |
Countries
France, Spain
Outcome results
None listed