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

NCT03891784 | Active Not Recruiting Phase 2 DMC FDA Drug

• 3 other identifiers: RG1004456NCI-2019-014909959
• Study Type: interventional
• Target: 20
• Locations: 1 country
• Sites: 2

Brief 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.

Conditions

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

Outcome Measures

Primary Outcomes (1)

• Objective response rate (ORR)

  ORR defined as complete or partial response as per Response Evaluation Criteria in Solid Tumors (RECIST) version (v) 1.1, will be represented by a waterfall plot.

  Up to 1 year after completion of study treatment

Secondary Outcomes (3)

• Progression-free survival

  From study registration to radiographic progression per RECIST v1.1 (investigator assessment), clinical progression, or death of any cause, assessed up to 1 year

• Overall survival

  Time from study registration to death of any cause, assessed up to 1 year

• Incidence of adverse events

  Up to 30 days

Study Arms (1)

Treatment (abemaciclib)

EXPERIMENTAL

Patients receive abemaciclib PO BID on days 1-28. Cycles repeat every 28 days in the absence of disease progression or unacceptable toxicity.

Drug: Abemaciclib

Interventions

Abemaciclib DRUG

Given PO

Also known as: Verzenio, 1231929-97-7, 2-Pyrimidinamine

Treatment (abemaciclib)

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Histologically confirmed GEP NET, radiographically progressed on at least one line of standard therapy within the past 12 months
• Primary tumors may be in: pancreas, foregut (esophagus, stomach, duodenum), midgut (small intestine, appendix), hindgut (large intestine, rectum), or unknown origin
• Tumors may be functional (associated with clinical symptoms of hormone secretion) or non-functional
• Well-differentiated NET with low grade (Ki67 index \< 3% or mitotic index \< 2 mitoses/10 high power field \[HPF\]), intermediate grade (Ki67 index 3-20% or mitotic index 2-20 mitoses/10 HPF), or high grade (Ki67 21% to ≤ 55% of mitotic index 21-55% mitoses/10 HPF). In cases where pathology reports call out only a "high grade neuroendocrine carcinoma", such patients are eligible only if well differentiated status is confirmed by a board-certified pathologist AND Ki-67 is ≤ 55%
• Metastatic or locally advanced unresectable disease
• Measurable disease by computed tomography (CT) or magnetic resonance imaging (MRI) as per Response Evaluation Criteria in Solid Tumors (RECIST) version (v) 1.1
• Prior or concurrent therapy with somatostatin analogs (SSAs) is allowed. If concurrent therapy, dose must be stable for at least 2 months
• Patients with carcinoid syndrome must have symptoms controlled with stable doses of SSAs for at least 2 months
• \* Telotristat is not allowed
• Age \>= 18 years
• Eastern Cooperative Oncology Group (ECOG) performance status of 0 to 2
• Able to swallow oral medications
• Absolute neutrophil count \>= 1500/uL
• Platelet count \>= 100,000/uL (without platelet transfusion for at least two weeks)
• Hemoglobin \>= 8 g/dL (blood transfusion is not allowed the day before or on the day of study treatment)

You may not qualify if:

• Presence of poorly differentiated neuroendocrine carcinoma (NEC) or mixed adenoneuroendocrine carcinomas (MANECs)
• Prior treatment with abemaciclib or other CDK4/6 inhibitors
• Known hypersensitivity to abemaciclib or its components
• Receipt of any therapy or investigational agent within 4 weeks prior to study registration, except SSAs
• Any surgery, radiation, or embolization within 4 weeks
• Peptide receptor radionuclide therapy (PRRT) within 6 weeks
• Patients receiving other investigational agents
• Patients who have not recovered from adverse events of prior therapy to =\< grade 1 (National Cancer Institute \[NCI\] Common Terminology Criteria for Adverse Events \[CTCAE\] version \[v\] 5), except for alopecia or grade =\< 2 peripheral neuropathy prior to study treatment initiation. Subjects must have fully recovered from the acute effects of any prior radiotherapy
• Patients with untreated or symptomatic brain metastases (must be off corticosteroids for \>= 4 weeks)
• Uncontrolled or untreated intercurrent illness including, but not limited to, active bacterial or fungal infection, congestive heart failure, severe/unstable angina, syncope of cardiac etiology, ventricular arrythmia (including but not limited to ventricular tachycardia, ventricular fibrillation), history of cardiac arrest, interstitial lung disease, severe dyspnea at rest or requiring oxygen supplementation, arterial or venous thrombotic event, pre-existing chronic condition resulting in baseline grade \>= 2 diarrhea, or psychiatric illness/social situations that would limit compliance with study requirements
• Gastrointestinal tract disease resulting in an inability to take oral medication or a requirement for intravenous (IV) alimentation, prior surgical procedures involving stomach or small bowel in the last 28 days, active peptic ulcer disease, Crohn's disease or ulcerative colitis
• Severe renal impairment (e.g. estimated creatinine clearance \< 30ml/min)
• Known history of infection with human immunodeficiency virus (HIV)
• Active untreated infection with hepatitis B virus (i.e. hepatitis B surface antigen positive) or hepatitis C virus (i.e. hepatitis C antibody and ribonucleic acid \[RNA\] positive)
• Other malignancy diagnosed or recurrent in the past 3 years (except non-melanoma skin cancer and in-situ cervical cancer)

Sponsors & Collaborators

• University of Washington: lead
• Eli Lilly and Company: collaborator

Study Sites (2)

University of Colorado

Denver, Colorado, 80217, United States

Location

Fred Hutch/University of Washington Cancer Consortium

Seattle, Washington, 98109, United States

Location

MeSH Terms

Conditions

Gastro-enteropancreatic neuroendocrine tumor; Adenoma, Islet Cell

Interventions

abemaciclib

Condition Hierarchy (Ancestors)

Adenoma; Neoplasms, Glandular and Epithelial; Neoplasms by Histologic Type; Neoplasms; Pancreatic Neoplasms; Digestive System Neoplasms; Neoplasms by Site; Endocrine Gland Neoplasms; Digestive System Diseases; Pancreatic Diseases; Endocrine System Diseases

Study Officials

• David B. Zhen

  Fred Hutch/University of Washington Cancer Consortium

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: March 25, 2019
• First Posted: March 27, 2019
• Study Start: October 31, 2019
• Primary Completion: November 1, 2025
• Study Completion (Estimated): July 1, 2026
• Last Updated: January 14, 2026

Record last verified: 2026-01

Data Sharing

• IPD Sharing: Will not share

Locations

US (2)