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CDK4/6 Inhibitor

Abemaciclib for Bile Duct Cancer

Phase 2
Waitlist Available
Led By Nelson Yee, MD, Ph.D
Research Sponsored by Milton S. Hershey Medical Center
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Be older than 18 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 3 years
Awards & highlights

Study Summary

This trial is testing a new drug to treat biliary tract cancer that has progressed after one line of chemotherapy.

Eligible Conditions
  • Bile Duct Cancer

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~3 years
This trial's timeline: 3 weeks for screening, Varies for treatment, and 3 years for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
overall response rate
Secondary outcome measures
Progression-free survival
disease control rate
overall survival rate
+1 more

Side effects data

From 2018 Phase 2 trial • 132 Patients • NCT02102490
91%
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%
Platelet count decreased
14%
Dry mouth
14%
Weight decreased
14%
Dysgeusia
13%
Dyspnoea
12%
Abdominal pain upper
12%
Back pain
12%
Dizziness
11%
Pyrexia
11%
Dyspepsia
11%
Oedema peripheral
11%
Blood creatinine increased
10%
Pain
9%
Stomatitis
9%
Aspartate aminotransferase increased
8%
Dry skin
8%
Thrombocytopenia
8%
Pruritus
8%
Lacrimation increased
8%
Dehydration
8%
Alanine aminotransferase increased
7%
Flatulence
7%
Urinary tract infection
7%
Upper respiratory tract infection
7%
Hypokalaemia
6%
Chills
6%
Musculoskeletal chest pain
6%
Musculoskeletal pain
6%
Anxiety
5%
Rash
5%
Gastrooesophageal reflux disease
5%
Myalgia
2%
Cellulitis
2%
Pleural effusion
1%
Atypical pneumonia
1%
Gastroenteritis viral
1%
Sepsis
1%
Hip fracture
1%
Pneumonitis
1%
Fall
1%
Lung infection
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: AbemaciclibExperimental Treatment1 Intervention
Abemaciclib will be given as a single oral agent A sample size of 10 subjects is determined to be minimally sufficient for these pilot study objectives. The starting dose will be 200 mg twice daily. Dosing will continue daily for 28 days, this being one cycle. There will be no protocol scheduled hiatus and daily dosing will be continuous unless there is unacceptable toxicity, disease progression, or death.
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Abemaciclib
2019
Completed Phase 2
~1710

Find a Location

Who is running the clinical trial?

Milton S. Hershey Medical CenterLead Sponsor
492 Previous Clinical Trials
2,798,818 Total Patients Enrolled
Eli Lilly and CompanyIndustry Sponsor
2,615 Previous Clinical Trials
3,201,054 Total Patients Enrolled
Nelson Yee, MD, Ph.DPrincipal InvestigatorPenn State Cancer Institute

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

How many people are currently taking part in this experiment?

"That is correct. The listing on clinicaltrials.gov currently shows that the trial is looking for 24 patients from 1 site. The posting date was March 29th, 2021 and the most recent editing was done on February 3rd, 2022."

Answered by AI

What are the chances that this clinical trial will pave the way for future research?

"Currently, 97 different ongoing clinical trials are using Abemaciclib. These investigations are being conducted in 1276 distinct cities spread out over 41 countries. The first ever study involving Abemaciclib was sponsored by Eli Lilly and Company back in 2009. This particular trial only had 220 participants and completed Phase 1 of the drug approval process. In the years since 2009, 30 more trials have completed."

Answered by AI

Are there any unfilled vacancies for participants in this trial?

"Yes, the study is recruiting patients at this time. According to information on clinicaltrials.gov, the trial was first posted on 3/29/2021 and last updated on 2/3/2022. They are looking for 24 participants total, from one location."

Answered by AI

Are there any severe side effects associated with taking Abemaciclib?

"Abemaciclib's safety is estimated to be a 2. This rating comes from the fact that this drug is currently in Phase 2 trials, meaning that while there is some data supporting safety, there is no data yet indicating whether or not the medication actually works."

Answered by AI

What ailments does Abemaciclib help alleviate?

"Abemaciclib is commonly used to prevent cancer recurrence in high-risk patients. It can also help manage hormone therapy and breast cancer."

Answered by AI
Recent research and studies
clinicaltrials.govStudy
A Study to Evaluate Abemaciclib in Advanced Biliary Tract Carcinoma
Nelson Yee, MD, PhD 2021. "A Study to Evaluate Abemaciclib in Advanced Biliary Tract Carcinoma". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT04003896.
~1 spots leftby Apr 2025
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