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)

Sponsor
National Cancer Institute, Naples
Study ID
NCT04893785
Phase
PHASE2
Status
Recruiting
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Conditions

  • GEP Neuroendocrine Tumor
  • Lung Neuroendocrine Neoplasm

Eligibility Criteria

Sex
ALL
Age
18 Years - N/A
Healthy Volunteers
Not accepted

Interventions

  • Cabozantinib and Temozolomide — DRUG
    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.

Study Details

The aim of CABOTEM study is to demonstrate the safety and activity of the Cabozantinib and Temozolomide combination in Lung and GEP-NENs patients, progressing after a first line therapy, including target therapies (everolimus, sunitinib) and / or chemotherapy, in the approved setting.

Key Dates

Start date
Jun 15, 2021
Status verified
Jun 2024
Primary completion
Jan 31, 2025
Completion
Dec 31, 2026

Study Design

Enrollment
35 participants (estimated)
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT

Arms

  • Experimental: Cabozantinib and Temozolomide
    All patients will receive: * Cabozantinib 40 mg os QD * Temozolomide 100 mg/m2/day seven days followed by seven days of stop (regimen one week on / one week off).

Primary Outcome Measure

To assess the efficacy of the combination of cabozantinib and one-week-on/one-week-off temozolomide, based on overall response rate (ORR). [ Time Frame: Up to 42 months ]

Central Contacts

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