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Cyclin-Dependent Kinase Inhibitor

Targeted Therapy for Brain Cancer

Phase 2
Recruiting
Research Sponsored by Alliance for Clinical Trials in Oncology
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
No chemotherapy within 14 days prior to registration
Chronic concomitant treatment with strong CYP3A4 inducers is not allowed
Timeline
Screening 3 weeks
Treatment Varies
Follow Up up to 5 years
Awards & highlights

Study Summary

This trial looks at whether genetic testing can help guide treatment for brain cancer. Medications that target specific genes may stop the growth of tumor cells.

Who is the study for?
This trial is for patients with solid tumors that have spread to the brain, who can undergo MRI scans and haven't had recent surgery or chemotherapy. They must not be pregnant or nursing, have no uncontrolled medical issues, and not be on certain drugs affecting liver enzymes. Participants need confirmed metastatic disease in the brain from a solid tumor with specific gene alterations (NTRK, ROS1, KRAS G12C, CDK pathway or PI3K pathway) and meet other health criteria.Check my eligibility
What is being tested?
The trial tests if genetic testing can guide treatment using targeted medications like abemaciclib, paxalisib, entrectinib and adagrasib for brain metastases from solid tumors. These drugs aim to block enzymes needed by tumor cells to grow by focusing on mutations found in genes related to cancer progression.See study design
What are the potential side effects?
Potential side effects of these treatments may include fatigue; gastrointestinal symptoms like nausea and diarrhea; blood count changes; possible liver enzyme alterations; risk of infections due to immune system impact; as well as unique side effects related to each drug's mechanism of action.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
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I haven't had chemotherapy in the last 14 days.
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I am not on any strong medication that affects liver enzyme levels.
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My cancer has spread to my brain from another part of my body.
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I have not had surgery within the last 2 weeks.
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My cancer has spread to my brain recently or is getting worse.
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I am not currently receiving any cancer treatments.
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I am not on any strong CYP3A4 inhibitors.
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I have tissue samples available from previous surgeries or biopsies for testing.
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My cancer has a specific change in NTRK, ROS1, KRAS G12C, CDK, or PI3K that can be treated.
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My cancer type has specific treatment history requirements.
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I am able to care for myself and perform daily activities.
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My organs are working well and my lab tests are within normal ranges.
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I have had radiation for symptom relief in my nervous system before joining.
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I have been on a stable dose of dexamethasone for at least 7 days.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~up to 5 years
This trial's timeline: 3 weeks for screening, Varies for treatment, and up to 5 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
Objective response rate in the brain
Secondary outcome measures
Clinical benefit rate for central nervous system (CNS)
Clinical benefit rate for extracranial disease
Duration of response for brain metastases
+7 more

Trial Design

4Treatment groups
Experimental Treatment
Group I: Arm IV (KRAS G12C mutation)Experimental Treatment1 Intervention
Patients receive adagrasib (MRTX849) PO BID on days 1-28. Cycles repeat every 28 days in the absence of disease progression or unacceptable toxicity.
Group II: Arm III (NTRK/ROS1 gene mutation)Experimental Treatment1 Intervention
Patients receive entrectinib PO QD on days 1-28. Cycles repeat every 28 days in the absence of disease progression or unacceptable toxicity.
Group III: Arm II (PI3K gene mutation)Experimental Treatment1 Intervention
Patients receive PI3K inhibitor paxalisib PO QD on days 1-28. Cycles repeat every 28 days in the absence of disease progression or unacceptable toxicity.
Group IV: Arm I (CDK gene mutation)Experimental Treatment1 Intervention
Patients receive abemaciclib PO BID on days 1-28. Cycles repeat every 28 days in the absence of disease progression or unacceptable toxicity.
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Abemaciclib
2019
Completed Phase 2
~1710
Adagrasib
2023
Completed Phase 1
~20
Entrectinib
2014
Completed Phase 2
~360

Find a Location

Who is running the clinical trial?

Mirati Therapeutics Inc.Industry Sponsor
69 Previous Clinical Trials
7,799 Total Patients Enrolled
Eli Lilly and CompanyIndustry Sponsor
2,605 Previous Clinical Trials
3,199,169 Total Patients Enrolled
Kazia Therapeutics LimitedIndustry Sponsor
11 Previous Clinical Trials
1,404 Total Patients Enrolled

Media Library

Abemaciclib (Cyclin-Dependent Kinase Inhibitor) Clinical Trial Eligibility Overview. Trial Name: NCT03994796 — Phase 2
Brain Metastasis Research Study Groups: Arm IV (KRAS G12C mutation), Arm III (NTRK/ROS1 gene mutation), Arm I (CDK gene mutation), Arm II (PI3K gene mutation)
Brain Metastasis Clinical Trial 2023: Abemaciclib Highlights & Side Effects. Trial Name: NCT03994796 — Phase 2
Abemaciclib (Cyclin-Dependent Kinase Inhibitor) 2023 Treatment Timeline for Medical Study. Trial Name: NCT03994796 — Phase 2

Frequently Asked Questions

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

Is this experimental trial a pioneering endeavor?

"Currently, there are 106 active clinical trials for the PI3K Inhibitor paxalisib across 1346 cities and 57 countries. This pharmacological agent was first trialled in 2009 by Eli Lilly & Co with 220 participants. 38 studies have been successfully completed since then, attaining Phase 1 drug approval status."

Answered by AI

What medical applications is PI3K Inhibitor paxalisib typically employed for?

"Paxalisib, a PI3K inhibitor, is designed to combat solid tumors and malignant neoplasms in cases where surgical resection is not possible or when no known resistance mutations have been acquired."

Answered by AI

What potential risks does the PI3K Inhibitor paxalisib pose to individuals using it?

"Our experts at Power gave the PI3K Inhibitor Paxalisib a rating of 2 on our safety scale. This is due to Phase 2 trial data, which implies that prior studies have provided evidence for its safety but not efficacy."

Answered by AI

What is the participant quota for this research trial?

"This medical trial necessitates 150 qualified patients, who can be recruited from a variety of places such as the University of Chicago Comprehensive Cancer Center in Illinois or the University of Kansas Cancer Center-Overland Park located in Kansas."

Answered by AI

Is enrollment open for this research endeavor?

"Affirmative, clinicaltrials.gov states that this medical trial is actively enrolling patients since it was first publicized on August 15th 2019. The last update to the study occured on June 3rd 2022 and seeks 150 participants across 100 different sites."

Answered by AI

How many health facilities are currently participating in this trial?

"This clinical trial requires 100 participants and is currently recruiting from medical centres such as the University of Chicago Comprehensive Cancer Centre, the University of Kansas Cancer Center-Overland Park, and Genesee Cancer & Blood Disease Treatment Centre. Additional enrolment sites can be found around the world."

Answered by AI

Have previous studies explored the efficacy of PI3K Inhibitor paxalisib?

"Research into the PI3K Inhibitor paxalisib began in 2009 and has since been tested 38 times, with 106 studies actively recruiting participants. If you require more information about these trials, call 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) on weekdays between 9 AM to 5 PM Eastern Time or contact your personal physician. Most of these clinical experiments are occurring in Chicago, Illinois."

Answered by AI
~18 spots leftby Oct 2024