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CDK4/6 Inhibitor
LY3214996 + Abemaciclib for Glioblastoma
Phase < 1
Recruiting
Led By Nader Sanai, MD
Research Sponsored by Nader Sanai
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 60 months
Awards & highlights
Summary
This trial is testing a new cancer treatment on 50 people with recurrent glioblastoma. The treatment will be given before surgery to remove the tumor.
Who is the study for?
This trial is for adults over 18 with recurrent glioblastoma who've had prior treatment including surgery, temozolomide, and radiotherapy. They must have measurable disease, specific genetic features in their tumor tissue, and be able to swallow pills. Pregnant or breastfeeding individuals can't join; neither can those with certain heart conditions, severe infections or liver diseases, a history of blood clots in the eye causing vision loss, or those on coumarin anticoagulants.
What is being tested?
The trial tests LY3214996 plus Abemaciclib given before surgical removal of brain tumors in patients with recurrent glioblastoma. Initially up to 10 participants will receive this combination therapy; if successful based on PK results from Phase 0 and enrollment into Phase 2 reaches at least five participants, around 40 more may join for further evaluation.
What are the potential side effects?
Potential side effects include reactions related to liver function changes (like jaundice), fatigue due to low red blood cell counts (anemia), increased risk of infection from white blood cell changes (neutropenia), bleeding issues due to low platelets (thrombocytopenia), digestive disturbances such as diarrhea or nausea.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ up to 60 months
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~up to 60 months
Treatment Details
Study Objectives
Study objectives can provide a clearer picture of what you can expect from a treatment.Primary study objectives
Pharmacokinetic analysis of plasma
Phase 0: Pharmacokinetic analysis of cerebrospinal fluid (CSF)
Phase 0: Pharmacokinetic analysis of tumor tissue
+1 moreSecondary study objectives
Deaths
Incidence of clinical laboratory abnormalities per CTCAE
Incidence of drug-related toxicity
+3 moreTrial Design
1Treatment groups
Experimental Treatment
Group I: Arm 1Experimental Treatment2 Interventions
400 mg of LY3214996 QD for 6 doses and 100 mg of Abemaciclib BID for 11 doses over 5.5 days prior to surgical resection. On Day 6, participants will receive Abemaciclib + LY3214996 dose 7 to 9 hours prior to craniotomy for tumor resection.
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Abemaciclib
2019
Completed Phase 2
~1800
LY3214996
2019
Completed Phase 2
~270
Find a Location
Who is running the clinical trial?
Nader SanaiLead Sponsor
8 Previous Clinical Trials
278 Total Patients Enrolled
6 Trials studying Glioblastoma
176 Patients Enrolled for Glioblastoma
Barrow Neurological InstituteOTHER
25 Previous Clinical Trials
6,975 Total Patients Enrolled
7 Trials studying Glioblastoma
203 Patients Enrolled for Glioblastoma
Ivy Brain Tumor CenterOTHER
11 Previous Clinical Trials
789 Total Patients Enrolled
8 Trials studying Glioblastoma
653 Patients Enrolled for Glioblastoma
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Eligibility Criteria:
This trial includes the following eligibility criteria:- You have a current and serious bacterial or fungal infection that requires intravenous antibiotics or a detectable viral infection such as HIV or Hepatitis B/C. You don't need to get tested for these infections to join the study.You have already taken medicines like CDK4/6 inhibitors or ERK1/2 inhibitors as part of your treatment.You have taken part in another experimental treatment or received any other intervention within the last 30 days or 5 half-lives of the investigational product, whichever is longer.You can take medication by mouth without difficulty.
Timeline:
This trial has the following timeline:- Screening: It may take up to 3 Weeks to process to see if you qualify in this trial.
- Treatment: The duration you will receive the treatment varies.
- Follow Ups: You may be asked to continue sharing information regarding the trial for 6 Months after you stop receiving the treatment.
Awards:
This trial has 1 awards, including:- No Placebo-Only Group - All patients enrolled in this study will receive some form of active treatment.
Research Study Groups:
This trial has the following groups:- Group 1: Arm 1
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