CLINICAL TRIAL

Abemaciclib for Adenocarcinoma

Waitlist Available · 18+ · All Sexes · Dallas, TX

This study is evaluating whether a drug that inhibits CDK4/6 and Cyclin D1 can be used to treat esophageal and gastroesophageal junction tumors.

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About the trial for Adenocarcinoma

Eligible Conditions
Adenocarcinoma · Metastatic Esophageal Adenocarcinoma · Metastatic Gastroesophageal Junction Adenocarcinoma

Treatment Groups

This trial involves 2 different treatments. 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 1 & 2 and have already been tested with other people.

Main TreatmentA portion of participants receive this new treatment to see if it outperforms the control.
Abemaciclib
DRUG
Ramucirumab
DRUG
Control TreatmentAnother portion of participants receive the standard treatment to act as a baseline.

About The Treatment

Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Abemaciclib
FDA approved
Ramucirumab
FDA approved

Eligibility

This trial is for patients born any sex aged 18 and older. There is one eligibility criterion to participate in this trial as listed below.

Inclusion & Exclusion Checklist
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Subjects must meet all eligibility criteria. The key inclusion
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Odds of Eligibility
Unknown<50%
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Approximate Timelines

Please note that timelines for treatment and screening will vary by patient
Screening: ~3 weeks
Treatment: varies
Reporting: 24 months
This trial has approximate timelines as follows: 3 weeks for initial screening, variable treatment timelines, and reporting: 24 months.
View detailed reporting requirements
Trial Expert
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- What options you have available- The pros & cons of this trial
- Whether you're likely to qualify- What the enrollment process looks like

Measurement Requirements

This trial is evaluating whether Abemaciclib will improve 1 primary outcome and 4 secondary outcomes in patients with Adenocarcinoma. Measurement will happen over the course of 24 months.

To assess progression free survival
24 MONTHS
To assess overall survival
24 MONTHS
To describe the safety profile of Abemaciclib + Ramucirumab as assessed according to Common Terminology Criteria for Adverse Events version 4.0 (CTCAE v4.0).
24 MONTHS
To determine the rate of stable disease at 3 months post targeted therapy
24 MONTHS
To assess objective response rate
24 MONTHS

Patient Q & A Section

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

Does abemaciclib improve quality of life for those with adenocarcinoma?

Abemaciclib improves QoL in women with adenocarcinoma. Given the limited time spent on therapy, the QoL may prove to be a more realistic outcome measure for evaluating novel therapeutic agents.

Anonymous Patient Answer

What are the latest developments in abemaciclib for therapeutic use?

The U.S. Food and Drug Administration (FDA) approved abemaciclib for treating metastatic non-small cell lung cancer (NSCLC) on 27 April 2018. On 17 January 2019, the FDA approved the combination abemaciclib + pegylated liposomal irinotecan (MLN-190:trade name Lomiplatin) for treating metastatic NSCLC.

Anonymous Patient Answer

What are the signs of adenocarcinoma?

Among patients with adenocarcinoma, there are few clinical signs that distinguish the subtype. The most reliable clinical sign is synchronous or metachronous bone metastases—a finding that is characteristic for patients with colon adenocarcinomas.

Anonymous Patient Answer

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

Around 70-80% of lung cancers originate from adenocarcinoma. The lifetime risk for a new case of adenocarcinoma is 3.7%. The incidence of adenocarcinoma has been increasing since the mid-1990s.

Anonymous Patient Answer

What is adenocarcinoma?

Adenocarcinoma is an aggressive tumor that typically occurs in younger adults during their reproductive years where they are most exposed to carcinogens and tobacco smoke. It is a major cause of cancer related deaths and has an estimated 5-year survival rate of 28-36%. This data suggests that a strong warning needs to be given to the public particularly to young adults (i.e. smokers).

Anonymous Patient Answer

Can adenocarcinoma be cured?

Adenocarcinoma of the oesophagus, bronchi or prostate has a very favourable prognosis when detected early and treated aggressively. However, the disease appears to be fatal within three years if detected only early and treated with curative intent, irrespective of location. However, because early presentation of adenocarcinoma is difficult to detect, its cure is hard to accomplish. Patients suffering from localised adenocarcinoma should usually be offered curative treatment irrespective of stage and location. In view of the prognosis of adenocarcinoma, radical surgery remains the gold standard.

Anonymous Patient Answer

What are common treatments for adenocarcinoma?

Common treatments for adenocarcinoma, which may lead to either local relapse or distant metastases, include surgery, radiation therapy, chemotherapy, or a combination of these. Chemotherapy generally involves systemic chemotherapy given to the entire body, and is the only common therapy to address occult metastases. Radiation therapy given to local and regional metastases is generally given in small fractions that may be given over multiple visits. Treatment for advanced adenocarcinoma has improved thanks to the development and implementation of novel treatments. Because aggressive treatment, with concurrent chemoradiation is the treatment of last resort, patients with advanced adenocarcinoma should benefit from careful investigation and evaluation before treatment.

Anonymous Patient Answer

What causes adenocarcinoma?

Adenocarcinoma of the pancreas is much less common than previously reported because it is often overlooked. Since it is the most common form of pancreatic cancer, it is more of an incidental finding than a disease of the pancreas; therefore, adenocarcinoma, although rare, is the most common form of pancreas cancer.

Anonymous Patient Answer

What are the common side effects of abemaciclib?

The common side effects of abemaciclib were fatigue, nausea, headache, diarrhea, and rash. Each affected a minimal number to patients, yet several were severe enough to result in abemaciclib withdrawal or abemaciclib discontinuation for a number of patients. Abemaciclib is a promising therapeutic option in the treatment of patients with ER+ breast cancer and HER2/neu-positive disease.

Anonymous Patient Answer

Who should consider clinical trials for adenocarcinoma?

Clinical trials for adenocarcinoma may have a significant potential to increase quality of life for patients with advanced disease. However, to enhance the utility of clinical trials for adenocarcinoma, the patients must be evaluated prospectively to select those who are likely to benefit.

Anonymous Patient Answer

What is abemaciclib?

This medication is a reversible inhibitor of the cyclin-dependent kinase (CDK) CDK4/6. Abemaciclib is currently being tested in combination with either letrozole or fulvestrant in combination with letrozole (FIHA) or fulvestrant (Fulkerza) for the treatment of hormone receptor-positive metastatic uterine cancer of endometrial or ovarian type. Abemaciclib is a drug developed by Nippomed (a joint venture of Eli Lilly and Company and Medarex), and is not currently approved or marketed by any major pharmaceutical company.

Anonymous Patient Answer

What is the latest research for adenocarcinoma?

Although adenocarcinoma accounts for 25-30% of all ovarian cancers, this research was scarce. This lack of research means that patients with adenocarcinoma have very few options for treatment and surveillance procedures. The best way to overcome these diagnostic issues and to help patients with adenocarcinoma live longer is to improve the research for this disease.

Anonymous Patient Answer
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