Solid tumours Cancer
Conditions
Interventions
Capsules containing 20 mg of S 78454 administered orally. Treatment duration is at the discretion of the investigator.
Sponsors
Pharmacyclics LLC (USA)
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1. Solid tumour, with measurable or evaluable disease, requiring a course of hypofractionated radiotherapy 2. Ability to swallow oral capsule(s) without difficulty 3. Eastern Cooperative Oncology Group (ECOG) performance status less than or equal to 2 4. Estimated life expectancy of more than 20 weeks 5. 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. Previous radiotherapy on the same area 5. Cumulative radiation therapy involving more than 25% of the total bone marrow 6. 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 7. Concurrent therapeutic anticoagulation by Vitamin K antagonists 8. Patients treated by valproic acid 9. Risk factors for, or use of medications known to prolong QTc interval and that may be associated with Torsades de Pointes.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Dose-limiting toxicity (DLT) and maximum tolerated dose (MTD) at the end of cycle measured by adverse events monitoring | — |
Secondary
| Measure | Time frame |
|---|---|
| 1. Safety profile at each visit measured by adverse events monitoring 2. Tumour response evaluation at baseline and at the final visit measured by imaging and blood tests 3. Tumour perfusion measurements only for schedule 1 using functional imaging 4. Exploration of changes in biological markers (optional part in schedule 1) using biopsies | — |
Countries
France, Italy
Outcome results
None listed