Your session is about to expire
← Back to Search
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
No Placebo-Only Group
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 moreSide effects data
From 2024 Phase 2 trial • 52 Patients • NCT0438605760%
Nausea
55%
Fatigue
45%
Anemia
45%
Hyponatremia
40%
Alkaline phosphatase increased
35%
Abdominal pain
35%
Alanine aminotransferase increased
35%
Vomiting
35%
Anorexia
35%
Hypoalbuminemia
30%
Aspartate aminotransferase increased
25%
Electrocardiogram QT corrected interval prolonged
20%
Constipation
20%
CPK increased
20%
Diarrhea
20%
Dehydration
20%
Hypokalemia
20%
Platelet count decreased
20%
Back pain
15%
Urinary tract infection
15%
Generalized muscle weakness
15%
Fever
15%
Chills
15%
Confusion
15%
Creatinine increased
15%
Hypocalcemia
15%
Blood bilirubin increased
10%
Dry mouth
10%
Hypomagnesemia
10%
Hyperkalemia
10%
Hyperglycemia
10%
Acidosis
10%
Bloating
10%
Cough
10%
Dyspnea
10%
Lymphocyte count decreased
10%
Weight loss
10%
Acute kidney injury
10%
Edema limbs
5%
Pruritus
5%
Somnolence
5%
Fall
5%
Generalized edema
5%
Rash acneiform
5%
Skin ulceration
5%
Flatulence
5%
Hyperhidrosis
5%
Hypernatremia
5%
Blood lactate dehydrogenase increased
5%
Pain
5%
Urinary retention
5%
Hyperphosphatemia
5%
Hypertension
5%
Cardiac troponin T increased
5%
Hiccups
5%
Insomnia
5%
Myalgia
5%
Rash maculo-papular
5%
Stroke
5%
Dizziness
5%
Dysgeusia
5%
Metabolism and nutrition disorders - Other, specify
5%
Pleural effusion
5%
Thrush
5%
Anxiety
5%
Hoarseness
5%
Hypoglycemia
5%
Hypotension
5%
Hypothyroidism
5%
Investigations - Other, specify
5%
Leukocytosis
5%
Sepsis
5%
Death NOS
5%
Respiratory failure
5%
Abdominal distension
5%
Hot flashes
5%
Musculoskeletal and connective tissue disorder - Other, specify
5%
Blood and lymphatic system disorders - Other, specify
5%
Ascites
5%
Skin and subcutaneous tissue disorders - Other, specify
100%
80%
60%
40%
20%
0%
Study treatment Arm
LY3214996 and HCQ Combination
Cross Over Arm
Safety Lead-In Cohort: Dose Level -1 (200mg LY3214996)
Safety Lead-In Cohort: Dose Level 0 (400mg LY3214996)
LY3214996-Monotherapy
Awards & Highlights
No Placebo-Only Group
All patients enrolled in this study will receive some form of active treatment.
Trial 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
~1890
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
26 Previous Clinical Trials
6,985 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
Eli Lilly and CompanyIndustry Sponsor
2,680 Previous Clinical Trials
3,466,334 Total Patients Enrolled
8 Trials studying Glioblastoma
1,346 Patients Enrolled for Glioblastoma
Nader Sanai, MDPrincipal Investigator - Deputy Director of the Ivy Brain Tumor Center
Barrow Neurological Institute at St. Joseph's, Chandler Regional Medical Center, Select Specialty Hospital-Phoenix, St. Joseph's Hospital & Medical Center
University Of California (Medical School)
University Ca Sf School Of Medicine (Residency)
13 Previous Clinical Trials
969 Total Patients Enrolled
8 Trials studying Glioblastoma
646 Patients Enrolled for Glioblastoma
Media Library
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