Patients
primary peritoneal cancer, ovarian cancer, histologically-confirmed ovarian, histologically-confirmed glioblastoma, Glioblastoma, cardiac disease, glioblastoma
OVARIAN CANCER, CEREBRAL HEMORRHAGE, RECURRENCE, TRANSIENT ISCHEMIC ATTACK, DISEASE, GLIOBLASTOMA, ISCHEMIC STROKE, CARDIAC DISEASE, ONCOLOGY, GLIOBLASTOMA, CEREBRAL ANEURYSM, PERIPHERAL NEUROPATHY
The study population comprised adult patients (≥ 18 years) with either histologically-confirmed ovarian, fallopian-tube, or primary peritoneal cancer that was platinum-resistant or refractory (the ‘ovarian cancer cohort’), or with histologically-confirmed glioblastoma at first recurrence (the ‘glioblastoma cohort’). Key inclusion criteria were life expectancy ≥ 12 weeks, acceptable organ and marrow function within 15 days prior to starting study drug, Eastern Cooperative Oncology Group (ECOG) performance status ≤ 1 (the ovarian cancer cohort) or ≤ 2 (the glioblastoma cohort), and at least one site of measurable disease as defined by RECIST version 1.1 (ovarian cancer) or RANO criteria (glioblastoma). Glioblastoma patients who were being treated with steroids had to be on a stable or decreasing dose. Patients were excluded if they had received chemotherapy, radiotherapy, immunotherapy, or any investigational agents within 4 weeks (6 weeks for nitrosoureas or mitomycin C, 12 weeks for radiotherapy of glioblastoma) prior to receiving the study drug. Other exclusion criteria were the presence of peripheral neuropathy ≥ CTCAE grade 2, systolic blood pressure ≥ 140 mmHg or diastolic blood pressure ≥ 90 mmHg, and combination treatment with more than two anti-hypertensive medications. Patients with significant cardiac disease or abnormalities, and those with a history of cerebral hemorrhage, cerebral aneurysm, ischemic stroke, or a history of transient ischemic attack within 24 months prior to screening, were also excluded.