25
Participants
Start Date
August 7, 2019
Primary Completion Date
August 7, 2020
Study Completion Date
August 7, 2022
Cabozantinib 20 MG
Cabozantinib will be administered orally at a (starting) dose of 60 mg once daily. The drug is taken continuously over a period of 28 days (4 weeks), which constitutes one treatment cycle. In all subjects, dose reductions (40mg 20mg) and delays to manage toxicity.
Cabozantinib 40 MG
Cabozantinib will be administered orally at a (starting) dose of 60 mg once daily. The drug is taken continuously over a period of 28 days (4 weeks), which constitutes one treatment cycle. In all subjects, dose reductions (40mg 20mg) and delays to manage toxicity.
Cabozantinib 60 MG
Cabozantinib will be administered orally at a (starting) dose of 60 mg once daily. The drug is taken continuously over a period of 28 days (4 weeks), which constitutes one treatment cycle. In all subjects, dose reductions and delays to manage toxicity. Cabozantinib should be taken in fasting condition with no food for at least 2 hours before and 1 hour after taking the tablets. A high fat meal significantly increased the median tmax to 6 hours from 4 hours (fasted). The treatment will be continued until disease progression, intolerable toxicity, patient refusal or Investigator's decision or any criterion for withdrawal from the trial or trial drug is fulfilled.
NOT_YET_RECRUITING
Oncologia Medica 2 -Policlinico San Martino, Genova
NOT_YET_RECRUITING
S.S. di Oncologia Medica toraco-polmonare - Fondazione IRCCS - Istituto Nazionale Tumori, Milan
NOT_YET_RECRUITING
UOC di Oncologia Medica - Azienda Sanitaria Universitaria Integrata di Udine, Udine
NOT_YET_RECRUITING
UOC di Oncologia Medica 2 - IOV Istituto Oncologico Veneto, Padua
RECRUITING
OU di Oncologia Medica- Azienda ospedaliero-Universitaria S. Orsola Malpighi, Bologna
NOT_YET_RECRUITING
UOC di Oncologia Medica- Azienda Ospidaliero Universitaria di Parma, Parma
NOT_YET_RECRUITING
UO Pneumologia - A.O.U Pisana, Pisa
NOT_YET_RECRUITING
U.O.C Pneumologia ad Indirizzo Oncologico -AORN Ospedali dei Colli Monaldi-Cotugno-CTO, Napoli
NOT_YET_RECRUITING
U.O di Oncologia Medica Policlinico V.Emanuele-G.Rodolico, Catania
NOT_YET_RECRUITING
US di Oncologia Medica - A.O. di Perugia, Perugia
NOT_YET_RECRUITING
S.C. di Oncologia Medica - IFO - Istituto Regina Elena, Roma
Collaborators (1)
AOU S.Orsola Malpighi-Unit of Oncologic Molecular and Transplantations Pathology
UNKNOWN
Bioikos Ambiente Srl
OTHER
Ipsen
INDUSTRY
Mipharm SpA
UNKNOWN
University of Bologna
OTHER