NCT03891784

Abemaciclib in Treating Patients With Advanced, Refractory, and Unresectable Digestive System Neuroendocrine Tumors

A Phase 2 Trial of the CDK4/6 Inhibitor Abemaciclib in Patients With Advanced and Refractory Well-Differentiated Gastroenteropancreatic Neuroendocrine Tumors (GEP NETs)

• Status: Active Not Recruiting
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 20 (actual)
• Sponsor: University of Washington · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

This phase II trial studies how well abemaciclib works in treating patients with digestive system neuroendocrine tumors that have spread to other places in the body, do not respond to treatment, and cannot be removed by surgery. Abemaciclib may stop the growth of tumor cells by blocking some of the enzymes needed for cell growth.

Detailed description

Patients receive abemaciclib orally (PO) twice daily (BID) on days 1-28. Cycles repeat every 28 days in the absence of disease progression or unacceptable toxicity. After completion of study treatment, patients are followed up at 30 days and then every 4 months for up to 1 year.

Conditions

• Advanced Digestive System Neuroendocrine Neoplasm
• Digestive System Neuroendocrine Tumor
• Foregut Neuroendocrine Tumor
• Hindgut Neuroendocrine Tumor
• Locally Advanced Unresectable Digestive System Neuroendocrine Neoplasm
• Metastatic Digestive System Neuroendocrine Neoplasm
• Midgut Neuroendocrine Tumor
• Pancreatic Neuroendocrine Tumor
• Refractory Digestive System Neuroendocrine Neoplasm

Interventions

Type	Name	Description
DRUG	Abemaciclib	Given PO

Timeline

• Start date: 2019-10-31
• Primary completion: 2025-11-01
• Completion: 2026-07-01
• First posted: 2019-03-27
• Last updated: 2026-01-14

Locations

2 sites across 1 country: United States

Regulatory

• FDA-regulated drug study