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CDK4/6 Inhibitor
Abemaciclib for Neuroendocrine Tumors
Phase 2
Recruiting
Led By Kaylyn Kit Man Wong
Research Sponsored by University of Washington
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
Measurable disease by computed tomography (CT) or magnetic resonance imaging (MRI) as per Response Evaluation Criteria in Solid Tumors (RECIST) version (v) 1.1
Age >= 18 years
Must not have
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
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
Timeline
Screening 3 weeks
Treatment Varies
Follow Up from study registration to radiographic progression per recist v1.1 (investigator assessment), clinical progression, or death of any cause, assessed up to 1 year
Awards & highlights
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.
Who is the study for?
Adults with advanced, treatment-resistant digestive system neuroendocrine tumors that can't be surgically removed. Participants must be able to take oral meds, have measurable disease by CT or MRI, and meet specific blood count and organ function criteria. Women of childbearing potential and men must agree to use effective contraception.
What is being tested?
The trial is testing the effectiveness of Abemaciclib in patients whose neuroendocrine tumors have spread and are not responding to other treatments. The drug aims to inhibit enzymes necessary for tumor cell growth.
What are the potential side effects?
Abemaciclib may cause fatigue, diarrhea, low white blood cell counts (increasing infection risk), liver enzyme changes, deep vein thrombosis or pulmonary embolism (blood clots), and potential harm to a fetus if taken during pregnancy.
Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowSelect...
My cancer can be measured on scans according to specific criteria.
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I am 18 years old or older.
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My cancer has spread and cannot be removed with surgery.
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My hemoglobin level is at least 8 g/dL without recent blood transfusions.
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I can take care of myself and am up and about more than half of my waking hours.
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My carcinoid syndrome symptoms are managed with stable medication for 2+ months.
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My liver enzymes are within the acceptable range.
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My cancer has worsened after treatment in the last year.
Exclusion Criteria
You may be eligible for the trial if you check “No” for criteria below:Select...
I have recovered from previous cancer treatment side effects, except for hair loss or mild nerve damage.
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I do not have any severe illnesses that are not under control.
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My kidneys are not working well (creatinine clearance < 30ml/min).
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I have an active, untreated hepatitis B or C infection.
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I have not had surgery, radiation, or embolization in the last 4 weeks.
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My cancer is a type of aggressive neuroendocrine tumor.
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I have not had PRRT treatment in the last 6 weeks.
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I have brain metastases but haven't used corticosteroids for 4 weeks.
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I have previously been treated with abemaciclib or similar medications.
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I have been diagnosed with HIV.
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I have not had any cancer, except for non-melanoma skin or in-situ cervical cancer, in the past 3 years.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ from study registration to radiographic progression per recist v1.1 (investigator assessment), clinical progression, or death of any cause, assessed up to 1 year
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~from study registration to radiographic progression per recist v1.1 (investigator assessment), clinical progression, or death of any cause, assessed up to 1 year
Treatment Details
Study Objectives
Study objectives can provide a clearer picture of what you can expect from a treatment.Primary study objectives
Objective response rate (ORR)
Secondary study objectives
Incidence of adverse events
Overall survival
Progression-free survival
Side effects data
From 2018 Phase 2 trial • 132 Patients • NCT0210249091%
Diarrhoea
67%
Nausea
48%
Fatigue
45%
Decreased appetite
35%
Vomiting
27%
Anaemia
26%
Abdominal pain
23%
Asthenia
23%
Neutrophil count decreased
21%
Cough
20%
Constipation
20%
Headache
19%
Arthralgia
18%
White blood cell count decreased
18%
Neutropenia
15%
Alopecia
14%
Dry mouth
14%
Platelet count decreased
14%
Weight decreased
14%
Dysgeusia
13%
Dyspnoea
12%
Abdominal pain upper
12%
Back pain
12%
Dizziness
11%
Oedema peripheral
11%
Dyspepsia
11%
Pyrexia
11%
Blood creatinine increased
10%
Pain
9%
Stomatitis
9%
Aspartate aminotransferase increased
8%
Thrombocytopenia
8%
Lacrimation increased
8%
Dehydration
8%
Dry skin
8%
Pruritus
8%
Alanine aminotransferase increased
7%
Flatulence
7%
Upper respiratory tract infection
7%
Urinary tract infection
7%
Hypokalaemia
6%
Chills
6%
Musculoskeletal chest pain
6%
Musculoskeletal pain
6%
Anxiety
5%
Gastrooesophageal reflux disease
5%
Rash
5%
Myalgia
2%
Cellulitis
2%
Pleural effusion
1%
Atypical pneumonia
1%
Gastroenteritis viral
1%
Lung infection
1%
Sepsis
1%
Fall
1%
Hip fracture
1%
Pneumonitis
1%
Pneumothorax
1%
Febrile neutropenia
1%
Respiratory tract infection
1%
Haematotoxicity
1%
Sinus bradycardia
1%
Tachycardia
1%
Large intestinal obstruction
1%
Pancreatic enzyme abnormality
1%
Pancreatitis
1%
Varices oesophageal
1%
Electrocardiogram abnormal
1%
Liver function test abnormal
1%
Renal function test abnormal
1%
Bone pain
1%
Muscular weakness
1%
Acute kidney injury
1%
Pulmonary embolism
1%
Arterial thrombosis
1%
Epilepsy
100%
80%
60%
40%
20%
0%
Study treatment Arm
Abemaciclib
Trial Design
1Treatment groups
Experimental Treatment
Group I: Treatment (abemaciclib)Experimental Treatment1 Intervention
Patients receive abemaciclib PO BID on days 1-28. Cycles repeat every 28 days in the absence of disease progression or unacceptable toxicity.
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Abemaciclib
2019
Completed Phase 2
~1800
Find a Location
Who is running the clinical trial?
University of WashingtonLead Sponsor
1,762 Previous Clinical Trials
1,876,445 Total Patients Enrolled
1 Trials studying Neuroendocrine Tumors
77 Patients Enrolled for Neuroendocrine Tumors
Eli Lilly and CompanyIndustry Sponsor
2,629 Previous Clinical Trials
3,218,073 Total Patients Enrolled
2 Trials studying Neuroendocrine Tumors
72 Patients Enrolled for Neuroendocrine Tumors
Kaylyn Kit Man WongPrincipal InvestigatorFred Hutch/University of Washington Cancer Consortium
1 Previous Clinical Trials
2 Total Patients Enrolled
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- 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.
Research Study Groups:
This trial has the following groups:- Group 1: Treatment (abemaciclib)
Awards:
This trial has 1 awards, including:- No Placebo-Only Group - All patients enrolled in this study will receive some form of active treatment.
Timeline:
This trial has the following timeline:- 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.
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