Cabozantinib for Pancreatic Neuroendocrine Tumors

Recruiting at 494 trial locations

Overseen By Jonathan R. Strosberg

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.

Research Team

Jennifer A Chan

Principal Investigator

Alliance for Clinical Trials in Oncology

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

Not pregnant and not nursing

You do not have any hollow spaces in your lungs.

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

Exclusion Criteria

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

Patient is living outside the US

I have had a condition where my lymphocytes grow abnormally.

Treatment Details

Interventions

• Cabozantinib S-malate (Tyrosine Kinase Inhibitor)

Trial Overview 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.

Participant Groups

Group I: Arm I (cabozantinib S-malate) Experimental Treatment 6 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 Group 6 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.

Who Is Running the Clinical Trial?

National Cancer Institute (NCI)

Lead Sponsor

Trials

14,080

Recruited

41,180,000+