Study on Abemaciclib for Treating Advanced Digestive System Neuroendocrine Tumors

Inclusion Criteria

• Have a confirmed diagnosis of neuroendocrine tumors in the digestive system that have progressed despite standard treatment within the past year.
• Tumors can originate from the pancreas, esophagus, stomach, small intestine, appendix, large intestine, rectum, or unknown origin.
• Tumors may produce symptoms related to hormone secretion or may not.
• Tumors must be well-differentiated and can be low, intermediate, or high grade based on specific medical criteria.
• Have cancer that has spread or is locally advanced and cannot be removed by surgery.
• Have measurable disease as determined by CT or MRI scans.
• May have had or be currently receiving somatostatin analogs (SSAs) if the dose is stable for at least 2 months.
• If experiencing carcinoid syndrome, symptoms must be controlled with stable doses of SSAs for at least 2 months.
• Be 18 years or older.
• Have a performance status score of 0 to 2, indicating full activity or some restriction in strenuous activities.
• Be able to swallow oral medications.
• Have adequate blood cell counts and organ function as determined by specific blood tests.
• Women of childbearing potential must have a negative pregnancy test before starting treatment and agree to use effective contraception during the study and for at least 3 weeks after the last dose.
• Men must agree to use effective contraception during the study and for at least 3 weeks after the last dose.

Exclusion Criteria

• Have poorly differentiated neuroendocrine carcinoma or mixed adenoneuroendocrine carcinomas.
• Have previously been treated with abemaciclib or similar drugs.
• Have allergies to abemaciclib or its components.
• Have received any other therapy or investigational agent within 4 weeks before starting the study, except SSAs.
• Have had surgery, radiation, or embolization within 4 weeks.
• Have had peptide receptor radionuclide therapy (PRRT) within 6 weeks.
• Are receiving other investigational agents.
• Have not recovered from side effects of previous treatments to a mild level, except for hair loss or mild nerve damage.
• Have untreated or symptomatic brain metastases.
• Have uncontrolled or untreated illnesses, including severe heart or lung conditions, infections, or psychiatric issues that would interfere with the study.
• Have gastrointestinal issues that prevent taking oral medication.
• Have severe kidney problems.
• Have a history of HIV infection.
• Have active untreated hepatitis B or C infections.
• Have had another cancer diagnosed or returned in the past 3 years, except for certain skin or cervical cancers.
• Are pregnant or breastfeeding.