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Pancreatic Neuroendocrine Tumors > Cabozantinib S-malate

Cabozantinib for Pancreatic Neuroendocrine Tumors

Recruiting in Palo Alto (17 mi)

+491 other locations

Overseen ByJennifer A Chan

Age: 18+

Sex: Any

Travel: May be covered

Time Reimbursement: Varies

Trial Phase: Phase 3

Waitlist Available

Sponsor: National Cancer Institute (NCI)

Pivotal Trial (Near Approval)

Prior Safety Data

Breakthrough Therapy

Approved in 3 jurisdictions

Trial Summary

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.

Eligibility Criteria

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

I do not have a history of inherited long QT syndrome.

I have not had a GI perforation in the last 6 months.

My cancer has not spread to or around any major blood vessels.

I am 18 years old or older.

My condition worsened or I couldn't tolerate my previous FDA-approved treatment.

My tumor has not invaded my digestive system, risking perforation or bleeding recently.

I can swallow pills without any issues.

My cancer cannot be removed by surgery and has spread.

My cancer is a neuroendocrine tumor from the pancreas, GI tract, lung, thymus, or an unknown site.

My cancer can be measured on a scan.

My tumor is a well- or moderately-differentiated neuroendocrine tumor.

I have not had severe heart failure in the last 6 months.

I haven't had serious heart rhythm problems in the last 6 months.

I haven't had serious stomach or intestine problems that could cause bleeding in the last 6 months.

I haven't had any non-healing wounds or ulcers in the last 28 days.

I do not have any active cancer except for non-melanoma skin cancer or cervical carcinoma in situ.

I am able to get out of my bed or chair and move around.

I am not planning to use other experimental treatments or cancer therapies while in this study.

My kidney function is normal or only slightly reduced.

I do not have any signs of pancreatitis.

I have not had any fractures in the last 28 days.

My lung cancer has not spread to the main airways or blood vessels.

My cancer is not a high-grade neuroendocrine, adenocarcinoid, or goblet cell carcinoid tumor.

Exclusion Criteria

My cancer is not a high-grade neuroendocrine, adenocarcinoid, or goblet cell carcinoid tumor.

I have had a condition where my lymphocytes grow abnormally.

I have a history of cancer.

I am currently taking medication to prevent blood clots.

I am not on any strong CYP3A4 inhibitors.

I am not on any strong medications that affect liver enzymes.

Participant Groups

This phase III trial is testing if cabozantinib works better than a placebo for treating advanced neuroendocrine or carcinoid tumors. Cabozantinib is a chemotherapy drug that blocks specific receptors which may slow tumor growth. Patients will also undergo scans and quality-of-life assessments.

2Treatment groups

Experimental Treatment

Placebo Group

Group I: Arm I (cabozantinib S-malate)Experimental Treatment6 Interventions

Patients receive cabozantinib S-malate PO QD on days 1-28 of each cycle. Cycles repeat every 28 days in the absence of disease progression or unacceptable toxicity. Patients also undergo blood and urine sample collection, and CT, MRI, and/or x-ray imaging during screening and on study.

Group II: Arm II (placebo)Placebo Group6 Interventions

Patients receive placebo PO QD on days 1-28 of each cycle. Cycles repeat every 28 days in the absence of disease progression or unacceptable toxicity. Patients also undergo blood and urine sample collection, and CT, MRI, and/or x-ray imaging during screening and on study. Patients may crossover to receive cabozantinib S-malate at the time of disease progression.

Cabozantinib S-malate is already approved in United States, United States, European Union for the following indications:

🇺🇸 Approved in United States as Cabometyx for: