Badanie fazy 1 mające na celu określenie bezpieczeństwa i farmakokinetyki selektywnego inhibitora kinazy MET DO-2 u pacjentów z zaawansowanymi lub opornymi nowotworami litymi

Kryteria wyłączenia kto nie może wziąć udziału (17)

1. tumour harbouring other known oncogenic mutations promoting tumour growth
2. major surgery within 3 weeks before enrolment
3. chemotherapy (in the case of nitrosoureas and mitomycin C within 6 weeks), radiotherapy, immunotherapy, or any other study drug within 3 weeks before study drug administration
4. antibody based cancer therapy within 4 weeks before administration of the first dose of DO-2
5. patients who became progressive on previous treatment with a MET-kinase inhibitor
6. patients with brain metastases are excluded unless all of the following criteria are met:
7. CNS lesions are asymptomatic and previously treated
8. No ongoing requirement for corticosteroids as therapy for CNS metastases
9. Imaging demonstrates stability of disease > 28 days from last treatment for CNS metastases
10. leptomeningeal involvement (leptomeningeal carcinomatosis)
11. history of uncontrolled heart disease including unstable angina, congestive heart failure, myocardial infarction within preceding 12 months, clinically significant rhythm or conduction abnormality, congenital long QT syndrome, obligate use of a cardiac pacemaker, QTc at screening greater than 450 milliseconds in males and greater than 470 milliseconds in females
12. uncontrolled arterial hypertension despite appropriate therapy
13. positive pregnancy test (urinary beta-hCG) at screening (applicable to women of child-bearing potential who are sexually active)
14. mental status alteration or history of major psychiatric illness, which may potentially impair patient's compliance with study procedures
15. signs and symptoms of active infection requiring systemic therapy
16. other medical condition (e.g. pre-existing kidney dysfunction) that in the opinion of the investigator makes it undesirable for a patient to participate
17. inability or unwillingness to swallow capsules and malabsorption syndrome or other condition that would interfere with enteral absorption