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CDK4/6 Inhibitor

LY3214996 + Abemaciclib for Cancer

Phase 2

Waitlist Available

Led By Anita Turk, MD

Research Sponsored by Anita Turk

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 up to 1 year

Awards & highlights

Study Summary

This trial is testing a combination of drugs to see if they are effective in treating cancer. The trial will continue until the cancer progresses, the patient has major side effects, or the patient withdraws from the trial.

Who is the study for?

This trial is for adults with advanced cancers that can't be surgically removed or have spread, and who haven't responded to standard treatments or refused them. They must have specific gene mutations identified by a certified test, good organ function, and no recent other cancer treatments. Pregnant women and those with untreated brain metastases or certain heart conditions are excluded.Check my eligibility

What is being tested?

The study tests the combination of two drugs: LY3214996 (200 mg daily) and abemaciclib (150 mg twice daily), taken orally until disease progression or unacceptable side effects occur. The goal is to assess the effectiveness of this drug combo in patients with particular genetic alterations related to cancer growth.See study design

What are the potential side effects?

Potential side effects include reactions typical for cancer therapies such as fatigue, digestive issues, blood disorders, liver problems, possible risk of infection due to lowered immune response, and others depending on individual health conditions.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ up to 1 year

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~up to 1 year

This trial's timeline: 3 weeks for screening, Varies for treatment, and up to 1 year 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

Duration of Overall Response Rate

Duration of Progression free survival

Incidence of Adverse Events

Trial Design

1Treatment groups

Experimental Treatment

Group I: Abemaciclib + LY3214996Experimental Treatment2 Interventions

Subjects will receive Abemaciclib 150 mg orally twice daily with LY3214996 200 mg orally daily until disease progression, unacceptable toxicity, or patient preference to withdraw from study.

Treatment

First Studied

Drug Approval Stage

How many patients have taken this drug

Abemaciclib

2019

Completed Phase 2

~1710

LY3214996

2019

Completed Phase 2

~270

Do I qualify?Apply below to find out

Find a Location

Who is running the clinical trial?

Anita TurkLead Sponsor

Eli Lilly and CompanyIndustry Sponsor

2,618 Previous Clinical Trials

3,201,544 Total Patients Enrolled

Anita Turk, MDPrincipal Investigator - Indiana University

Indiana University

Media Library

Abemaciclib (CDK4/6 Inhibitor) Clinical Trial Eligibility Overview. Trial Name: NCT04534283 — Phase 2

Cancer Research Study Groups: Abemaciclib + LY3214996

Cancer Clinical Trial 2023: Abemaciclib Highlights & Side Effects. Trial Name: NCT04534283 — Phase 2

Abemaciclib (CDK4/6 Inhibitor) 2023 Treatment Timeline for Medical Study. Trial Name: NCT04534283 — Phase 2

Frequently Asked Questions

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

What are some similar studies to this one that have been done in the past?

"LY3214996 has had a long research history, with the first clinical trials beginning in 2009. These initial studies were sponsored by Eli Lilly and Company. After the successful Phase 1 trial of 220 people, LY3214996 received drug approval. Currently, there are 97 live studies involving 1276 cities and 41 countries."

Answered by AI

Are there still opportunities to join this research project?

"This clinical trial is currently recruiting participants, as indicated on the clinicaltrials.gov website. The study was originally posted on September 28th, 2020 and was last edited on September 19th, 2022."

Answered by AI

Does LY3214996 have any negative side effects?

"LY3214996's Phase 2 status indicates that there is some data supporting its safety, but no clinical evidence yet for the efficacy of the medication. Our team at Power gave it a score of 2."

Answered by AI

What are the primary benefits of LY3214996?

"LY3214996 is often used to treat high-risk conditions that have a high chance of recurring. In addition, this medication can be prescribed for breast cancer patients who are endocrine therapy resistant and those with advanced hormone receptor positive and HER2 negative breast cancer."

Answered by AI

Recent research and studies

clinicaltrials.govStudy

A Basket Trial of an ERK1/2 Inhibitor (LY3214996) in Combination With Abemaciclib.

Anita Turk 2020. "A Basket Trial of an ERK1/2 Inhibitor (LY3214996) in Combination With Abemaciclib.". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT04534283.