Abemaciclib, for Small Cell Lung Carcinoma

Phase-Based Progress Estimates
1
Effectiveness
2
Safety
Case Medical Center, University Hospitals Seidman Cancer Center, Case Comprehensive Cancer Center, Cleveland, OH
Small Cell Lung Carcinoma+2 More
Abemaciclib, - Drug
Eligibility
18+
All Sexes
Eligible conditions
Select

Study Summary

Targeted Therapy With CDK4/6 Inhibitors in Chemo-Refractory, Rb Wild-Type Extensive SCLC

See full description

Eligible Conditions

  • Small Cell Lung Carcinoma
  • Small-cell Lung Cancer

Treatment Effectiveness

Effectiveness Estimate

1 of 3

Study Objectives

This trial is evaluating whether Abemaciclib, will improve 1 primary outcome and 4 secondary outcomes in patients with Small Cell Lung Carcinoma. Measurement will happen over the course of Up to 90 days from end of treatment.

Month 6
Progression Free Survival (PFS) according to RECIST 1.1
Year 10
Overall Survival (OS)
Year 2
Duration of response in all responders (DoR using RECIST 1.1)
Overall Response Rate (ORR)
Day 90
Safety and adverse events (AE's) and serious adverse events (SAE's) (CTCAE grade version 5.0).

Trial Safety

Safety Estimate

2 of 3
This is better than 68% of similar trials

Trial Design

1 Treatment Group

Abemaciclib
1 of 1
Experimental Treatment

This trial requires 29 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
Subjects will receive Abemaciclib (200 mg), orally every 12 hours on days 1 to 28 of a 28-day cycle for a total of 56 doses per cycle. Subjects will be evaluated after 4 weeks (1st cycle) and then every 8 weeks (2 cycles) with radiographic imaging to assess response to treatment.

Trial Logistics

Trial Timeline

Approximate Timeline
Screening: ~3 weeks
Treatment: Varies
Reporting: up to 10 years from start of study.
This trial has the following approximate timeline: 3 weeks for initial screening, variable treatment timelines, and roughly up to 10 years from start of study. for reporting.

Closest Location

Case Medical Center, University Hospitals Seidman Cancer Center, Case Comprehensive Cancer Center - Cleveland, OH

Eligibility Criteria

This trial is for patients born any sex aged 18 and older. You must have received 1 prior treatment for Small Cell Lung Carcinoma or one of the other 2 conditions 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:
People who have small cell lung cancer that has spread extensively (stage 4) must have a tissue sample that confirms the diagnosis. show original
The pathology confirmed that the patient had Retinoblastoma, and the testing showed that it was a wild type gene. show original
Platinum refractory disease is when a person doesn't respond to one or two rounds of chemotherapy show original
Subjects must have a disease that can be measured using the Response Evaluation Criteria in Solid Tumors (RECIST), version 1.1. show original
, Subjects with tumors available for study may be able to participate in the trial show original
This person has a performance status of ECOG Performance status ≤ 2, which means that they are in relatively good shape. show original
Patients who have finished chemotherapy and have recovered from the acute effects (except for residual hair loss or Grade 2 peripheral neuropathy) are allowed to enroll, but must have a 21-day washout period between the last chemotherapy dose and enrollment show original
Prior to enrolling in this study, patients must have completed and fully recovered from the acute effects of radiotherapy show original
Patients who have undergone brain metastasis treatment are eligible for the study as long as their follow-up brain imaging shows no evidence of progression. show original
The patient can swallow oral medications. show original

Patient Q&A Section

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

"There are approximately 30,000 cases of SCLC diagnosed each year in the United States. This makes [lung cancer](https://www.withpower.com/clinical-trials/lung-cancer) the fifth highest leading cause of cancer-related deaths in US." - Anonymous Online Contributor

Unverified Answer

What is small cell lung carcinoma?

"The most common causes of death in patients with SCLC are pneumonitis (16%) and pneumonia (13%); however, for SCLC, chemotherapy decreases the incidence of pneumonia and pneumonitis, and radiotherapy increases the incidence of metastatic disease. SCLC accounts for 8% to 10% of all deaths and 20% to 40% of all lung malignancies diagnosed yearly in the United States." - Anonymous Online Contributor

Unverified Answer

What are common treatments for small cell lung carcinoma?

"Small-cell lung cancer is treatable and has a low rate of recurrence when treated with chemotherapy. Treatment is typically with combined chemotherapy and/or radiation for small-cell lung carcinoma. The treatment of small-cell lung carcinoma depends markedly on the size, location, the presence of disease or metastases, and the extent of involvement of the mediastinum." - Anonymous Online Contributor

Unverified Answer

What are the signs of small cell lung carcinoma?

"There are no clinical and radiological features that accurately diagnose NSCLC. Therefore, routine imaging such as PET or CT scan with PET/CT should always be considered when there is suspicion of NSCLC." - Anonymous Online Contributor

Unverified Answer

Can small cell lung carcinoma be cured?

"As some small cell lung carcinomas are associated with a poor prognosis, there is considerable justification for a trial to test chemotherapeutic agents or combined modality therapy in this subset of patients." - Anonymous Online Contributor

Unverified Answer

What causes small cell lung carcinoma?

"The most common cause of small-cell lung carcinoma is smoking. The risk is also increased among those with radiodermatitis and/or exposed to ionizing radiation. These cancers are mostly curable if they are diagnosed early enough." - Anonymous Online Contributor

Unverified Answer

How serious can small cell lung carcinoma be?

"Survival from SCLC appears to be significantly better (P<0.0001) in patients with only limited disease and no extrapulmonary spread compared to other patients with Stage III disease. Local invasion appears to be more strongly associated with survival than extrapleural extension." - Anonymous Online Contributor

Unverified Answer

Have there been other clinical trials involving abemaciclib,?

"Abemaciclib was well tolerated in the trials included in the analysis and is the subject of 2 ongoing phase II trials. Further trials are planned on patients with breast cancer and people with advanced non-small cell lung cancer previously treated with abemaciclib." - Anonymous Online Contributor

Unverified Answer

What does abemaciclib, usually treat?

"[Abemaciclib is a new drug for small cell lung carcinoma(www.clinicaltrials.gov) The treatment of small cell lung carcinoma was found to affect the clinical symptoms of small cell lung carcinoma. It has also been found that the therapeutic effect on small cell lung carcinoma needs longer durations.[abemaciclib will be better therapy for small cell lung carcinoma]." - Anonymous Online Contributor

Unverified Answer

What are the chances of developing small cell lung carcinoma?

"There is a possibility that some people could have genetic mutations that make them predisposed to develop SCLC. There is also an chances of people developing lung cancer in a certain area of the body, as well as having specific genes of ones on a certain racial group or ethnicity. The risk of developing lung cancer in a certain group of people is very small." - Anonymous Online Contributor

Unverified Answer

How does abemaciclib, work?

"In vitro, abemaciclib blocks cell proliferation and invasion via a novel mechanism that is independent of CDKN1A and CDKN2A expression and, as such, it may have a utility in inhibiting tumor cell proliferation and survival in tumors with mutated BRCA1/2." - Anonymous Online Contributor

Unverified Answer

Has abemaciclib, proven to be more effective than a placebo?

"Overall, these data show that abemaciclib appears to be well tolerated. As shown in previous studies with another Abraxane, there is an increased incidence, but manageable, of side effects when compared with a placebo, including diarrhea and arthralgia." - 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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