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Abemaciclib for Neuroendocrine Tumors
Study Summary
This trial tests how well abemaciclib works in treating patients with neuroendocrine tumors that have spread, don't respond to treatment, and can't be removed by surgery.
Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowTimeline
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Side effects data
From 2018 Phase 2 trial • 132 Patients • NCT02102490Trial Design
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Who is running the clinical trial?
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- I do not have any severe illnesses that are not under control.My cancer can be measured on scans according to specific criteria.I have recovered from previous cancer treatment side effects, except for hair loss or mild nerve damage.My kidneys are not working well (creatinine clearance < 30ml/min).I am 18 years old or older.Your blood clotting tests should not be more than 1.5 times the upper limit of normal.My cancer has spread and cannot be removed with surgery.I can take pills by mouth.My hemoglobin level is at least 8 g/dL without recent blood transfusions.You must have a certain number of a type of white blood cell in your body.Your total bilirubin level is not more than 1.5 times the upper limit of normal.You are currently taking experimental medications for other conditions.I can take care of myself and am up and about more than half of my waking hours.I haven't taken any cancer treatments or experimental drugs in the last 4 weeks, except for SSAs.I cannot take pills due to stomach or bowel issues.My carcinoid syndrome symptoms are managed with stable medication for 2+ months.I have an active, untreated hepatitis B or C infection.My cancer originates from the pancreas, esophagus, stomach, intestines, or rectum.I have not had surgery, radiation, or embolization in the last 4 weeks.You are allergic to abemaciclib or any of its parts.My neuroendocrine tumor is well-differentiated and has a low, intermediate, or high but not exceeding 55% growth rate.I have been on a stable dose of somatostatin analogs for at least 2 months.My cancer is a type of aggressive neuroendocrine tumor.I have not had PRRT treatment in the last 6 weeks.I have brain metastases but haven't used corticosteroids for 4 weeks.You have Gilbert's syndrome with specific levels of bilirubin that are within certain limits.My liver enzymes are within the acceptable range.I am a man who is sterile or will use effective birth control during and 3 weeks after the study.I have previously been treated with abemaciclib or similar medications.Your kidneys are not working well enough.My cancer has worsened after treatment in the last year.I have been diagnosed with HIV.You need to have a certain amount of platelets in your blood.My tumor may or may not cause hormone-related symptoms.I have not had any cancer, except for non-melanoma skin or in-situ cervical cancer, in the past 3 years.
- Group 1: Treatment (abemaciclib)
- No Placebo-Only Group - All patients enrolled in this study will receive some form of active treatment.
- Screening: It may take up to 3 Weeks to process to see if you qualify in this trial.
- Treatment: The duration you will receive the treatment varies.
- Follow Ups: You may be asked to continue sharing information regarding the trial for 6 Months after you stop receiving the treatment.
Frequently Asked Questions
What indications is Abemaciclib regularly prescribed to address?
"Abemaciclib is typically administered to patients with a higher risk of relapse. It has also been prescribed in the past for conditions such as advanced hr+ her2- breast cancer, endocrine therapy and general breast health management."
Has Abemaciclib been given the green light from the Federal Drug Administration?
"With evidence of safety but no data yet demonstrating efficacy, Abemaciclib has been judged a 2 on our team's risk assessment scale."
Has there been any further research into Abemaciclib's efficacy?
"Abemaciclib was initially explored as an experimental medication in 2009. Presently, there are 92 actively enrolling trials and 31 completed studies pertaining to this drug. Those wishing to gain more information regarding research sites should contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or consult their personal physician. The majority of these investigations are located in Seattle, Washington."
Is this research a pioneering endeavor?
"Abemaciclib has been studied since 2009 when the first clinical trial was backed by Eli Lilly and Company. This research involved 220 participants, which eventually led to Abemaciclib's Phase 1 drug approval. At present, 92 studies are actively taking place across 1276 cities in 41 countries worldwide."
Are there still enrollment opportunities for this research project?
"According to information found on clinicaltrials.gov, this medical experiment is actively seeking participants with the first posting being dated October 31st 2019 and most recent update made August 1st 2022."
How many participants are actively engaged in this research initiative?
"Affirmative, the clinicaltrials.gov page states that enrollment is ongoing for this trial which first appeared on October 31st 2019 and was last modified on August 1st 2022. The study requires 37 prospective participants to be enrolled across 2 sites."
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