NCT03891784Active, not recruitingPhase 2
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)
Source: ClinicalTrials.gov · Last updated 14 Jan 2026
Brief summary (registry, in English)
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.
- Status (registry)
- Active, not recruiting
- Phase (registry)
- Phase 2
- Study type
- Interventional
- Enrollment
- 20 (actual)
- First submitted
- 25 Mar 2019
- Start date
- 31 Oct 2019
- Primary completion date
- 1 Nov 2025
- Lead sponsor
- University of Washington
- Diseases
- Neuroendocrine tumours, Pancreatic cancer
- NCT number
- NCT03891784
What you commit to
- Study type: Interventional · Phase 2
- Participants enrolled: 20
- From 31 Oct 2019 to the primary completion date, 1 Nov 2025
- 2 sites in 1 country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Prior treatment
- Prior treatment with abemaciclib or other CDK4/6 inhibitors
- 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)
- 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
Other illness
- Known hypersensitivity to abemaciclib or its components
- 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
- 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)
Lab values
- Severe renal impairment (e.g. estimated creatinine clearance \< 30ml/min)
Other
- Presence of poorly differentiated neuroendocrine carcinoma (NEC) or mixed adenoneuroendocrine carcinomas (MANECs)
- Pregnancy or breast-feeding
Who the study is looking for
- 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
Age in the registry: 18 years to - · Sex: All · Does not accept healthy volunteers
Sites (2)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| University of Colorado Coordinator of this site? Confirm its status | Denver | United States | Unknown status |
| Fred Hutch/University of Washington Cancer Consortium Coordinator of this site? Confirm its status | Seattle | United States | Unknown status |
This page is information, not medical advice. Discuss any trial with your doctor.