Testing Cabozantinib in Patients With Advanced Pancreatic Neuroendocrine and Carcinoid Tumors

Conditions

• Functioning Pancreatic Neuroendocrine Tumor
• Intermediate Grade Lung Neuroendocrine Neoplasm
• Locally Advanced Digestive System Neuroendocrine Neoplasm
• Locally Advanced Digestive System Neuroendocrine Tumor G1
• Locally Advanced Lung Neuroendocrine Neoplasm
• Locally Advanced Pancreatic Neuroendocrine Tumor
• Locally Advanced Unresectable Digestive System Neuroendocrine Neoplasm
• Low Grade Lung Neuroendocrine Neoplasm
• Lung Neuroendocrine Tumor
• Lung Neuroendocrine Tumor G2
• Metastatic Digestive System Neuroendocrine Neoplasm
• Metastatic Digestive System Neuroendocrine Tumor G1
• Metastatic Lung Neuroendocrine Neoplasm
• Metastatic Lung Neuroendocrine Tumor
• Metastatic Pancreatic Neuroendocrine Neoplasm
• Metastatic Pancreatic Neuroendocrine Tumor
• Metastatic Thymus Neuroendocrine Neoplasm
• Neuroendocrine Neoplasm
• Neuroendocrine Tumor
• Neuroendocrine Tumor G2
• Non-Functioning Pancreatic Neuroendocrine Tumor
• Pancreatic Serotonin-Producing Neuroendocrine Tumor
• Thymus Neuroendocrine Tumor
• Unresectable Digestive System Neuroendocrine Neoplasm
• Unresectable Digestive System Neuroendocrine Tumor G1
• Unresectable Lung Neuroendocrine Neoplasm
• Unresectable Pancreatic Neuroendocrine Neoplasm
• Unresectable Thymus Neuroendocrine Neoplasm

Eligibility Criteria

Sex

ALL

Age

18 Years - N/A

Healthy Volunteers

Not accepted

Interventions

• Biospecimen Collection — PROCEDURE
  Undergo blood and urine sample collection
• Cabozantinib S-malate — DRUG
  Given PO
• Computed Tomography — PROCEDURE
  Undergo CT
• Magnetic Resonance Imaging — PROCEDURE
  Undergo MRI
• Placebo Administration — OTHER
  Given PO
• Quality-of-Life Assessment — OTHER
  Ancillary studies
• X-Ray Imaging — PROCEDURE
  Undergo x-ray

Study Details

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.

Key Dates

Start date

Oct 26, 2018

Status verified

Mar 2026

Primary completion

Aug 23, 2023

Completion

Aug 19, 2026

Study Design

Enrollment

298 participants (actual)

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Arms

• Experimental: Arm I (cabozantinib S-malate)
  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.
• Placebo Comparator: Arm II (placebo)
  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.

Primary Outcome Measure

Progression-free Survival (PFS) [ Time Frame: 36 months ]

Locations (433)

Find similar trials in Anchorage, AK

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