Phase I Clinical and Pharmacokinetic Study of Pazopanib in a Population of Frail Elderly Patients According SIOG Criteria
Status:
Terminated
Trial end date:
2018-03-01
Target enrollment:
Participant gender:
Summary
This is an open-label, multicenter, non-randomized, phase 1 dose escalation clinical trial to
determine the MTD (Maximal Tolerated Dose) of Pazopanib in a population of frail elderly
patients, selected according to the International Society of Geriatric Oncology
(SIOG)classification (Group 2).
It is expected that a total number of 30 patients maximum will be enrolled in the study on 30
months : 18 months accrual - 12 months follow up.
Eligible patients will be enrolled into a standard 3+3 design with a starting dose of
Pazopanib administered orally at 400 mg per day, in 28-day cycles. Then, further dose levels
will be explored.
Toxicity of the schedule will be assessed during the first cycle. Patients will receive study
medication until disease progression. After treatment discontinuation, patients will be
followed during one year.