Solid tumours Cancer Malignant neoplasm, unspecified
Conditions
Interventions
Capsules containing 20 mg and 100 mg / oral use / 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 > or equal to 18 2. Solid tumour with measurable or evaluable disease, that has relapsed or is refractory to conventional standard forms of therapy 3. Ability to swallow oral capsule(s) without difficulty 4. Estimated life expectancy > 12 weeks 5. Eastern Cooperative Oncology Group (ECOG) performance status less or equal to 1 6. Adequate haematological, renal and hepatic functions
Exclusion criteria
Exclusion criteria: 1. Allogenic bone marrow transplant 2. Major surgery within previous 4 weeks 3. Chemotherapy within previous 3 weeks (6 weeks in case of nitrosoureas) 4. Radiotherapy within previous 4 weeks (except for palliative radiotherapy at localised lesions) 5. Immunotherapy or hormonotherapy within previous 2 weeks, except stable luteinizing hormone-releasing hormone (LHRH) agonist therapy for prostate cancer, stable oral glucocorticoid and mineralocorticoid replacement for adrenal insufficiency, stable mitotane for adrenal carcinoma, or oral contraceptives 6. Concurrent therapeutic anticoagulation by anti-vitamin K (AVK) 7. Patients treated by valproic acid 8. Any other previous (in the last 3 years) or concurrent cancer, other than resected non-melanoma skin cancer or cancer in situ of the uterine cervix 9. Risk factors for, or use of drugs known to prolong QTc interval and that may be associated with Torsades de Pointes
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| 1. Maximum tolerated dose (MTD) 2. Dose limiting toxicity (DLT) of S 78454. This is evaluated at the end of cycle 1. | — |
Secondary
| Measure | Time frame |
|---|---|
| 1. Safety profile at each visit 2. Pharmacokinetics (PK) and pharmacodynamics (PD) parameters: PK parameters are evaluated in cycle 1, and PD parameters during cycle 1, cycle 2 and cycle 3 3. Tumour response at baseline and every 2 cycles | — |
Countries
France
Outcome results
None listed