Phase I Clinical and Pharmacokinetic Study of Pazopanib in a Population of Frail Elderly Patients According SIOG Criteria

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.

Timeline

Start

2012-11-22

Primary completion

2017-09

Completion

2018-03

Publications

• Results Mourey L, Le Louedec F, Ravaud A, Paludetto MN, Digue L, Gomez-Roca CA, Valentin T, Balardy L, Olivier P, Cabarrou B, Filleron T, Chatelut E. VOTRAGE study: Phase I dose-escalation study of pazopanib in unfit older patients. J Geriatr Oncol. 2021 Jun;12(5):759-764. doi: 10.1016/j.jgo.2021.02.006. Epub 2021 Mar 11.

Drugs

Indications