Rak nerki: badanie fazy III leku pazopanib i abexinostat

Kryteria wyłączenia kto nie może wziąć udziału (9)

1. Patients who meet any of the following criteria at Screening will not be enrolled in the study:
2. Has persistent clinically significant toxicities (Grade ≥ 2; per NCI CTCAE version 5 from previous anticancer therapy (excluding alopecia which is permitted and excluding Grades 2 and 3 laboratory abnormalities if they are not associated with symptoms, are not considered clinically significant by the investigator, and can be managed with available medical therapies).
3. Has untreated central nervous system (CNS) metastases. Patients with treated CNS metastases are eligible provided imaging demonstrates no new or progressive metastases obtained at least 4 weeks following completion of treatment. CNS imaging during Screening is not required unless clinically indicated.
4. Has an additional malignancy requiring treatment within the past 3 years. Patients with the following concomitant neoplastic diagnoses are eligible: non-melanoma skin cancer, carcinoma in situ, and non-muscle invasive urothelial carcinoma.
5. Poorly controlled hypertension, defined as systolic blood pressure ≥ 160 or diastolic blood pressure ≥ 100 mmHg. Use of anti-hypertensives and rescreening is permitted.
6. A new pulmonary embolism or deep venous thrombosis diagnosed within 3 months prior to randomization.
7. Has a QTcF interval > 480 msec.
8. New York Heart Association Class III or IV congestive heart failure.
9. Use of prohibited medication within 7 days or 5 half-lives, whichever is shorter, prior to first dose of study drug.