Could abemaciclib be the next weapon against Hard-to-Treat gut tumors?
NCT ID NCT03891784
First seen Jun 27, 2026 · Last updated Jun 27, 2026
Summary
This phase 2 trial tests the drug abemaciclib (Verzenio) in 20 patients with advanced gastroenteropancreatic neuroendocrine tumors that have spread, are not responding to treatment, and cannot be surgically removed. The drug works by blocking enzymes that help cancer cells grow. The main goal is to see if the drug can shrink or slow the growth of these tumors.
What this could mean
Our plain-language read of the trial. This is informational only, not medical advice or a prediction.
- Active substance
- abemaciclib (Verzenio), a CDK4/6 inhibitor taken orally
- What this could lead to
- If successful, this could provide a new treatment option for patients with advanced neuroendocrine tumors that have stopped responding to standard therapies.
- What could go wrong
- This is a small, early-phase trial with only 20 participants, so results may not apply to all patients. The drug may not shrink tumors or improve survival, and side effects are possible.
This is an AI summary of the original study and may miss details. Read our disclaimer.
Study facts
What this study's own registry entry says, in plain language.
- Phase
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Phase 2
Tests whether the treatment actually works, and watches for side effects, in a larger group.
- Participants
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20 people
The number who actually took part.
- Started
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Oct 2019
- Expected to finish
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Jul 2026
An estimate. End dates often move.
- Lead sponsor
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Other sponsor
The registry's catch-all category, for sponsors it does not file as a company, a government agency, or a research network.
Who can take part
This study's own entry requirements. Only the study team can say for certain whether you qualify.
- Ages
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18 years and older
- Sex
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Anyone
- Healthy volunteers
-
Not accepted
This study is not open to healthy volunteers. The entry requirements below say who it is open to.
Show the full entry requirements Hide the full entry requirements
Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.
Inclusion Criteria: * 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) * Total bilirubin =\< 1.5 times upper limit of normal (ULN) * Transaminases (aspartate aminotransferase \[AST\] and/or alanine aminotransferase \[ALT\]) =\< 3 x upper limit of normal (ULN) (=\< 5 x ULN if liver metastases) * Patients with Gilbert's syndrome with a total bilirubin =\< 2.0 times ULN and direct bilirubin within normal limits are permitted * International normalized ratio (INR) and partial thromboplastin time (PTT) =\< 1.5 x ULN * Creatinine \> 30 mL/min * Ability to understand and sign the consent form * Women of child-bearing potential must: * Have a negative serum pregnancy test within 7 days prior to initiation of treatment, and * Agree to use a highly effective method of contraception during the study and for at least 3 weeks following the last dose of study drug * Men must be sterile or agree to use a highly effective method of contraception during the study and for at least 3 weeks following the last dose of study drug Exclusion Criteria: * 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) * Pregnancy or breast-feeding
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Conditions
The condition(s) this trial relates to.
As listed by the trial registrant
The condition terms exactly as the trial's registrant entered them.
Contacts and locations
Locations
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Fred Hutch/University of Washington Cancer Consortium
Seattle, Washington, 98109, United States
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University of Colorado
Denver, Colorado, 80217, United States
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Other studies related to the condition(s) this trial covers.
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