A Trial Evaluating the Activity and Safety of Combination Between Cabozantinib and Temozolomide in Lung and GEP-NENS Progressive After Everolimus, Sunitinib or PRRT (CABOTEM)

PHASE2RecruitingINTERVENTIONAL
Enrollment

35

Participants

Timeline

Start Date

June 15, 2021

Primary Completion Date

January 31, 2025

Study Completion Date

December 31, 2026

Conditions
Lung Neuroendocrine NeoplasmGEP Neuroendocrine Tumor
Interventions
DRUG

Cabozantinib and Temozolomide

"Patients enrolled will receive study medication until disease progression, unacceptable toxicity, withdrawal of consent or death, whichever comes first.~Patients will be required to attend clinic on Day 1, Day 8, Day 14 and Day 22 of every 4 week cycle.~Patients will return to clinic at 30 days (+/- 5 days) of their last dose of cabozantinib or temozolomide (whichever is discontinued last), for an end of treatment visit.~Following their end of treatment visit patients will be followed-up 3-monthly during routine clinic appointments to collect data on further anti-cancer treatment and survival. Follow-up will continue until 6 months after the last patient stops study treatment or up to 18 months after the last patient is randomised, whichever is sooner."

Trial Locations (1)

80131

RECRUITING

National Cancer Institute of Naples, Naples

All Listed Sponsors
lead

National Cancer Institute, Naples

OTHER