Cabozantinib for Pancreatic Neuroendocrine Tumors
What You Need to Know Before You Apply
What is the purpose of this trial?
This phase III trial studies cabozantinib to see how well it works compared with placebo in treating patients with neuroendocrine or carcinoid tumors that may have spread from where it first started to nearby tissue, lymph nodes, or distant parts of the body (advanced). Cabozantinib is a chemotherapy drug known as a tyrosine kinase inhibitor, and it targets specific tyrosine kinase receptors, that when blocked, may slow tumor growth.
Will I have to stop taking my current medications?
The trial requires stopping certain medications before participating. You must stop taking strong CYP3A4 inhibitors and inducers at least 14 days before joining. Full-dose oral anticoagulants are not allowed, but low-dose aspirin and stable doses of low molecular weight heparin are permitted.
Is cabozantinib generally safe for humans?
Cabozantinib has been studied for various cancers, and common side effects include skin reactions on hands and feet, high blood pressure, fatigue, and diarrhea. Serious side effects like gastrointestinal perforation and bleeding have also been reported, but these are managed with dose adjustments and supportive care.12345
How is the drug Cabozantinib unique for treating pancreatic neuroendocrine tumors?
Cabozantinib is unique because it targets multiple tyrosine kinases, including c-MET and VEGFR2, which play a key role in the development of neuroendocrine tumors. This drug has shown promising results in reducing tumor growth and inhibiting angiogenesis (formation of new blood vessels) in both laboratory and animal models, making it a novel option compared to other treatments.678910
What data supports the effectiveness of the drug Cabozantinib for treating pancreatic neuroendocrine tumors?
Cabozantinib is known to inhibit multiple tyrosine kinases, which play a key role in the development of neuroendocrine tumors. A phase II trial is assessing its safety and activity in combination with another drug for treating well-differentiated neuroendocrine tumors, including those in the pancreas.67111213
Who Is on the Research Team?
Jennifer A Chan
Principal Investigator
Alliance for Clinical Trials in Oncology
Are You a Good Fit for This Trial?
Adults with advanced neuroendocrine or carcinoid tumors that have spread and worsened after prior therapy can join. They must be able to swallow pills, not pregnant, no severe allergies to similar drugs as cabozantinib/placebo, and have a decent performance status (able to carry out daily activities). People with certain heart conditions, uncontrolled blood pressure, recent bleeding or clotting events, or other cancers within the last 5 years cannot participate.Inclusion Criteria
Exclusion Criteria
Timeline for a Trial Participant
Screening
Participants are screened for eligibility to participate in the trial
Treatment
Participants receive cabozantinib S-malate or placebo orally once daily in 28-day cycles, with regular blood and urine sample collection, and imaging studies
Follow-up
Participants are monitored for safety and effectiveness after treatment completion, with follow-up every 12 weeks until disease progression or new therapy, then every 6 months
What Are the Treatments Tested in This Trial?
Interventions
- Cabozantinib S-malate
Cabozantinib S-malate is already approved in United States, European Union for the following indications:
- Advanced renal cell carcinoma (RCC)
- Hepatocellular carcinoma (HCC)
- Locally advanced or metastatic differentiated thyroid cancer (DTC)
- Medullary thyroid cancer
- Advanced renal cell carcinoma (RCC)
- Hepatocellular carcinoma (HCC)
- Locally advanced or metastatic differentiated thyroid cancer (DTC)
Find a Clinic Near You
Who Is Running the Clinical Trial?
National Cancer Institute (NCI)
Lead Sponsor