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CDK4/6 Inhibitor

Abemaciclib for Glioblastoma

Phase 2
Waitlist Available
Led By Eudocia Q Lee, MD MPH
Research Sponsored by Dana-Farber Cancer Institute
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Participants must have a Karnofsky Performance Status (KPS) ≥ 60
Participants must undergo central pathology review to histologically confirm the diagnosis of glioblastoma, IDH-wildtype; glioblastoma variants; or astrocytoma, IDH-mutant, WHO grade 4
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 2 years
Awards & highlights

Study Summary

This trial is studying how well abemaciclib works in treating patients with recurrent glioblastoma.

Who is the study for?
Adults with recurrent glioblastoma who can take oral medication and adhere to the study schedule. They must have specific genetic markers (CDK4/6 amplification, wild-type RB status), a Karnofsky Performance Status of at least 60, and be able to provide tissue samples for research. Women must test negative for pregnancy and agree to contraception; men also need to use birth control.Check my eligibility
What is being tested?
The trial is testing Abemaciclib, a targeted therapy drug, on patients with recurrent glioblastoma after surgery. The aim is to see if this drug can effectively treat the cancer by focusing on certain genetic characteristics of the tumor cells.See study design
What are the potential side effects?
Abemaciclib may cause fatigue, diarrhea, low blood cell counts increasing infection risk or bleeding problems, liver issues indicated by altered lab tests, potential harm to unborn babies necessitating contraception use in both genders during treatment.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
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I can care for myself but may need occasional help.
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My brain tumor has been confirmed as a specific type by a specialized lab review.
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I am at least 18 years old.
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I have genetic test results from a certified lab.
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My brain cancer has returned for the first time.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~2 years
This trial's timeline: 3 weeks for screening, Varies for treatment, and 2 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
6-Month Progression Free Survival (PFS6)
Intratumoral abemaciclib concentration
Secondary outcome measures
Area under the plasma concentration versus time curve (AUC)
Incidence of Treatment-Emergent Adverse Events
Median Progression Free Survival
+4 more

Side effects data

From 2018 Phase 2 trial • 132 Patients • NCT02102490
91%
Diarrhoea
67%
Nausea
48%
Fatigue
45%
Decreased appetite
35%
Vomiting
27%
Anaemia
26%
Abdominal pain
23%
Asthenia
23%
Neutrophil count decreased
21%
Cough
20%
Constipation
20%
Headache
19%
Arthralgia
18%
White blood cell count decreased
18%
Neutropenia
15%
Alopecia
14%
Platelet count decreased
14%
Dry mouth
14%
Weight decreased
14%
Dysgeusia
13%
Dyspnoea
12%
Abdominal pain upper
12%
Back pain
12%
Dizziness
11%
Pyrexia
11%
Dyspepsia
11%
Oedema peripheral
11%
Blood creatinine increased
10%
Pain
9%
Stomatitis
9%
Aspartate aminotransferase increased
8%
Dry skin
8%
Thrombocytopenia
8%
Pruritus
8%
Lacrimation increased
8%
Dehydration
8%
Alanine aminotransferase increased
7%
Flatulence
7%
Urinary tract infection
7%
Upper respiratory tract infection
7%
Hypokalaemia
6%
Chills
6%
Musculoskeletal chest pain
6%
Musculoskeletal pain
6%
Anxiety
5%
Rash
5%
Gastrooesophageal reflux disease
5%
Myalgia
2%
Cellulitis
2%
Pleural effusion
1%
Atypical pneumonia
1%
Gastroenteritis viral
1%
Sepsis
1%
Hip fracture
1%
Pneumonitis
1%
Fall
1%
Lung infection
1%
Pneumothorax
1%
Febrile neutropenia
1%
Respiratory tract infection
1%
Haematotoxicity
1%
Sinus bradycardia
1%
Tachycardia
1%
Large intestinal obstruction
1%
Pancreatic enzyme abnormality
1%
Pancreatitis
1%
Varices oesophageal
1%
Electrocardiogram abnormal
1%
Liver function test abnormal
1%
Renal function test abnormal
1%
Bone pain
1%
Muscular weakness
1%
Acute kidney injury
1%
Pulmonary embolism
1%
Arterial thrombosis
1%
Epilepsy
100%
80%
60%
40%
20%
0%
Study treatment Arm
Abemaciclib

Trial Design

3Treatment groups
Experimental Treatment
Group I: Cohort 1 Surgery ArmExperimental Treatment2 Interventions
Participants who require reoperation will be treated with abemaciclib for 10-14 days prior to surgery. Tissue will be used to further investigate the abilities of Abemaciclib. After surgery participants will come off study and pursue standard of care treatments at their treating physician's discretion.
Group II: Abemaciclib without SurgeryExperimental Treatment1 Intervention
Abemaciclib will be administered on a continuous twice daily dosing schedule. Each Cycle last 28 days. NOTE: enrollment to this arm is complete
Group III: Abemaciclib with SurgeryExperimental Treatment2 Interventions
Abemaciclib will be administered on a continuous twice daily dosing schedule Patients who require re-operation will receive a short preoperative course of Abemaciclib Tissue will be used to investigate the ability of Abemaciclib to pass through the blood brain barrier. After recovery from surgery, participants will resume Abemaciclib. Each cycle lasts 28 days. NOTE: enrollment to this arm is complete
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Surgery
2000
Completed Phase 3
~2550
Abemaciclib
2019
Completed Phase 2
~1710

Find a Location

Who is running the clinical trial?

Eli Lilly and CompanyIndustry Sponsor
2,615 Previous Clinical Trials
3,201,013 Total Patients Enrolled
8 Trials studying Glioblastoma
1,170 Patients Enrolled for Glioblastoma
Dana-Farber Cancer InstituteLead Sponsor
1,079 Previous Clinical Trials
340,903 Total Patients Enrolled
23 Trials studying Glioblastoma
981 Patients Enrolled for Glioblastoma
Eudocia Q Lee, MD MPHPrincipal InvestigatorDana-Farber Cancer Institute

Media Library

Abemaciclib (CDK4/6 Inhibitor) Clinical Trial Eligibility Overview. Trial Name: NCT02981940 — Phase 2
Glioblastoma Research Study Groups: Cohort 1 Surgery Arm, Abemaciclib without Surgery, Abemaciclib with Surgery
Glioblastoma Clinical Trial 2023: Abemaciclib Highlights & Side Effects. Trial Name: NCT02981940 — Phase 2
Abemaciclib (CDK4/6 Inhibitor) 2023 Treatment Timeline for Medical Study. Trial Name: NCT02981940 — Phase 2

Frequently Asked Questions

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

Does this research mark a new milestone in its field?

"At this moment in time, 92 clinical trials for Abemaciclib are active across 41 different nations and 1276 urban centres. This drug was initially tested back in 2009, with Eli Lilly and Company sponsoring a Phase 1 investigation that included 220 participants. Since then, an additional 133 studies have been completed."

Answered by AI

Has the government approved Abemaciclib for public use?

"Abemaciclib has been evaluated in a Phase 2 trial, thus its safety rating is set at 2. This implies that while there is evidence of security, it's still lacking proof-of-efficacy data."

Answered by AI

Are there any vacancies for individuals wishing to join this clinical trial?

"Yes. Current information on clinicaltrials.gov affirms that this medical trial, which was first advertised on February 9th 2017, is actively enrolling participants. 42 individuals must be accepted from 4 different healthcare facilities."

Answered by AI

What past research exists regarding Abemaciclib?

"Abemaciclib has been researched since 2009. To access information on research sites, people can call 1-877-CTLILLY (1-877-285-4559) between 9 AM - 5 PM EST or consult their physician. As of now, 133 trials have already concluded and 92 are actively recruiting patients mostly in Los Angeles, California."

Answered by AI

What maladies are typically remedied by Abemaciclib?

"Abemaciclib is often used to reduce the recurrence of high risk medical conditions and can also be effective in treating advanced hr+her2-breast cancer, endocrine therapy, and breast."

Answered by AI

What is the scope of recruitment for this research endeavor?

"Eli Lilly and Company is organizing this medical trial, which requires 42 qualified patients to be enrolled. The study will take place in a few different locations, including the University of California Los Angeles in Los Angeles and Massachusetts General Hospital in Boston."

Answered by AI

Who else is applying?

What state do they live in?
California
What site did they apply to?
Massachusetts General Hospital
What portion of applicants met pre-screening criteria?
Met criteria
Recent research and studies
clinicaltrials.govStudy
A Study of Abemaciclib in Recurrent Glioblastoma
Eudocia Quant Lee, MD 2017. "A Study of Abemaciclib in Recurrent Glioblastoma". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT02981940.
All > Glioblastoma Long Beach > Utah
~1 spots leftby Jun 2024
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