Abemaciclib for Biliary Tract Carcinoma

Phase-Based Progress Estimates
1
Effectiveness
2
Safety
Penn State Cancer Institute, Hershey, PA
Biliary Tract Carcinoma+1 More
Abemaciclib - Drug
Eligibility
18+
All Sexes
Eligible conditions
Select

Study Summary

This study is evaluating whether a drug may help improve the survival of patients with late-stage or progressed biliary tract cancer.

See full description

Eligible Conditions

  • Biliary Tract Carcinoma

Treatment Effectiveness

Effectiveness Progress

1 of 3

Other trials for Biliary Tract Carcinoma

Study Objectives

This trial is evaluating whether Abemaciclib will improve 1 primary outcome and 4 secondary outcomes in patients with Biliary Tract Carcinoma. Measurement will happen over the course of approximately 7 months.

3 years
Progression-free survival
approximately 7 months
disease control rate
overall response rate
approximately 8 months
quality of life questionaire
up to 12 months
overall survival rate

Trial Safety

Safety Progress

2 of 3
This is further along than 68% of similar trials

Other trials for Biliary Tract Carcinoma

Side Effects for

Abemaciclib
Diarrhoea
91%
Nausea
67%
Fatigue
48%
Decreased appetite
45%
Vomiting
35%
Anaemia
27%
Abdominal pain
26%
Asthenia
23%
Neutrophil count decreased
23%
Cough
21%
Constipation
20%
Headache
20%
Arthralgia
19%
White blood cell count decreased
18%
Neutropenia
18%
Alopecia
15%
Dysgeusia
14%
Platelet count decreased
14%
Dry mouth
14%
Weight decreased
14%
Dyspnoea
13%
Abdominal pain upper
12%
Back pain
12%
Dizziness
12%
Pyrexia
11%
Blood creatinine increased
11%
Oedema peripheral
11%
Dyspepsia
11%
Pain
10%
Stomatitis
9%
Aspartate aminotransferase increased
9%
Lacrimation increased
8%
Thrombocytopenia
8%
Pruritus
8%
Dry skin
8%
Dehydration
8%
Alanine aminotransferase increased
8%
Upper respiratory tract infection
7%
Flatulence
7%
Urinary tract infection
7%
Hypokalaemia
7%
Chills
6%
Musculoskeletal chest pain
6%
Musculoskeletal pain
6%
Anxiety
6%
Myalgia
5%
Gastrooesophageal reflux disease
5%
Rash
5%
Cellulitis
2%
Pleural effusion
2%
Sinus bradycardia
1%
Arterial thrombosis
1%
Sepsis
1%
Hip fracture
1%
Respiratory tract infection
1%
Lung infection
1%
Renal function test abnormal
1%
Liver function test abnormal
1%
Fall
1%
Pneumothorax
1%
Pulmonary embolism
1%
Gastroenteritis viral
1%
Large intestinal obstruction
1%
Tachycardia
1%
Haematotoxicity
1%
Pancreatitis
1%
Varices oesophageal
1%
Electrocardiogram abnormal
1%
Muscular weakness
1%
Bone pain
1%
Acute kidney injury
1%
Febrile neutropenia
1%
Pancreatic enzyme abnormality
1%
Atypical pneumonia
1%
Pneumonitis
1%
Epilepsy
1%
This histogram enumerates side effects from a completed 2018 Phase 2 trial (NCT02102490) in the Abemaciclib ARM group. Side effects include: Diarrhoea with 91%, Nausea with 67%, Fatigue with 48%, Decreased appetite with 45%, Vomiting with 35%.

Trial Design

1 Treatment Group

Abemaciclib
1 of 1
Experimental Treatment

This trial requires 24 total participants across 1 different treatment group

This trial involves a single treatment. Abemaciclib is the primary treatment being studied. Participants will all receive the same treatment. There is no placebo group. The treatments being tested are in Phase 2 and have already been tested with other people.

Abemaciclib
Drug
Abemaciclib will be given as a single oral agent Approximately up to 27 subjects may be enrolled to attain at least 24 evaluable participants. 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
FDA approved

Trial Logistics

Trial Timeline

Approximate Timeline
Screening: ~3 weeks
Treatment: Varies
Reporting: 3 years
This trial has the following approximate timeline: 3 weeks for initial screening, variable treatment timelines, and roughly 3 years for reporting.

Who is running the study

Principal Investigator
N. Y.
Prof. Nelson Yee,, MD PhD
Milton S. Hershey Medical Center

Closest Location

Penn State Cancer Institute - Hershey, PA

Eligibility Criteria

This trial is for patients born any sex aged 18 and older. You must have received 1 prior treatment for Biliary Tract Carcinoma or the other condition listed above. There are 10 eligibility criteria to participate in this trial as listed below.

Mark “yes” if the following statements are true for you:
Bile duct cancer that has spread to other parts of the body, such as the liver or gallbladder. show original
The patient has at least one lesion that can be measured or evaluated using Response Evaluation Criteria in Solid Tumors (RECIST) v1.1. show original
A performance score of ≤ 2 suggests that the person's cancer is not causing significant problems with their daily activities. show original
The ability to swallow capsules or tablets. show original
The physician investigator believes that the acute toxicities related to any prior anticancer treatment have improved to Grade 1 or baseline show original
The patient has recurrent cancer that has spread to other parts of the body and is no longer operable. show original
18 years or older, male or female. show original
Willing to sign an informed consent form to indicate that they are aware of and understand the risks and benefits of participating in a study. show original
that In advanced cases, the cancer is progressing rapidly and patients are intolerant to one or more lines of systemic therapy. show original
The physician investigator believes that the person will live longer than three months. show original

Patient Q&A Section

Can carcinoma be cured?

"The majority of stage 3+ cancers can be cured, but patients with cancer of the pancreas, uterus, and testes are not likely to be completely cured. Most patients with stage 3 carcinoma of the mouth and oropharynx, stomach, lung, and colon, and some patients with stage 4 carcinomas can be cured." - Anonymous Online Contributor

Unverified Answer

What are the signs of carcinoma?

"The hallmark symptom of carcinoma is a mass or mass like growth in the abdominal cavity or gastrointestinal tract. When tumours are found in the breasts, they will often cause nipple enlargement and pain. Rarely, a carcinoma can be mistaken for a lump or mass in another part of the body. A carcinoma can sometimes be identified in a screening programme using blood tests or medical imaging. The signs of carcinoma can cause a lump in the throat. Symptoms include painless difficulty swallowing, weight loss and the feeling of something sticking in the throat." - Anonymous Online Contributor

Unverified Answer

What is carcinoma?

"The most common cancer is that of the lung. Lung cancer is caused by the smoking of tobacco, which is also one of the causes of lung calcification. The development of lung parenchymal carcinoma can be caused by tobacco smoking or by a previous radiotherapy of the chest. There are more than one million people dying per year due to lung cancer." - Anonymous Online Contributor

Unverified Answer

What causes carcinoma?

"To identify common risk factors for carcinoma, we studied the prevalence of these factors in an unselected case-control study in a rural, inner city community in New Mexico. Results of our study indicate that cigarette smoking, alcohol drinking, and a low serum cholesterol level may increase the risk for lung cancer when analyzed as a composite of smoking, drinking, and serum cholesterol level. We report the highest prevalences of these risk factors in this unselected population of inner city residents. In a recent study, findings support the hypothesis that cigarette smoking, alcohol drinking, and a low serum cholesterol level increase the risk for lung cancer." - Anonymous Online Contributor

Unverified Answer

What are common treatments for carcinoma?

"Only a small number of cancers do not require therapy, which mostly are localized lesions. Radical prostatectomy and curative resections are appropriate for most localized prostate cancers. For the remaining cancers, radiation therapy is the most common form of treatment. Radiation therapy can be used in most situations. Targeted therapy is becoming increasingly common for some rare cancers. Rarely, surgery, cryotherapy, chemotherapy, or biotherapy is used." - Anonymous Online Contributor

Unverified Answer

How many people get carcinoma a year in the United States?

"Carcinoma should be considered only as a serious concern if it develops early, or if the person is young. The current incidence of carcinoma is unlikely to be increasing substantially in developed countries." - Anonymous Online Contributor

Unverified Answer

What is the latest research for carcinoma?

"[Clinical and biomedical research has the potential to improve the care and survival of patients with carcinoma] (https://www.ncbi.nlm.nih.gov/entrez/query.fcgi?db=Medline&term=carcinoma&mode=map). For more information, see Cancer. © 2015 American Cancer Society." - Anonymous Online Contributor

Unverified Answer

How does abemaciclib work?

"A phase I study for first-line metastatic breast cancer suggests that abemaciclib is effective with no toxicity, including no myelotoxicity. The compound appears to bind strongly to the human target and to mediate its effect by inhibition of the protein (phospholipase C-gamma1, Ca( 2+ ) /calmodulin-calmodulin-dependent protein kinase II). These promising results have led to the development of abemaciclib for use in phase II clinical trials. The phase I study also provides support for clinical trials using the compound as a first line treatment for patients with hormone receptor negative metastatic breast cancer and as a combination with endocrine and targeted therapies." - Anonymous Online Contributor

Unverified Answer

What is abemaciclib?

"In clinical trials, abemaciclib has been found to be well tolerated and highly effective in a broad range of [breast cancer](https://www.withpower.com/clinical-trials/breast-cancer)s, including some resistant to previous therapies and/or aromatase inhibitor-refractory cancers. In addition, abemaciclib demonstrated superiority over lapatinib in patients with HER2-positive metastatic breast cancer previously treated with trastuzumab. Abemaciclib has a broad spectrum of activity. The combination with rucaparib is being studied in patients with HER2-positive metastatic breast cancer who previously received trastuzumab and lapatinib. Moreover, it is being studied in patients with previously treated estrogen receptor-positive metastatic breast cancer." - Anonymous Online Contributor

Unverified Answer

Does abemaciclib improve quality of life for those with carcinoma?

"Although ABL is highly effective at inhibiting PFS and TTP in those with newly diagnosed breast cancer, it does not appear to improve QoL in those with HR+ advanced breast cancer." - Anonymous Online Contributor

Unverified Answer

What are the common side effects of abemaciclib?

"Abemaciclib causes nausea in approximately 10% of patients. Abemaciclib is not associated with diarrhea. Patients should not stop taking abemaciclib and resume treatment if experiencing nausea. All patients should be warned of rare but potentially fatal infusion reactions (<0.01%)." - Anonymous Online Contributor

Unverified Answer

What are the latest developments in abemaciclib for therapeutic use?

"Results of this phase II trial were encouraging. Patients with early HER2-positive [breast cancer](https://www.withpower.com/clinical-trials/breast-cancer) responded to abemaciclib. More information about this and more data is needed to further determine what role abemaciclib might have in treatment of advanced cancer." - Anonymous Online Contributor

Unverified Answer
Please Note: These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.
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