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CDK4/6 Inhibitor

Abemaciclib + Bevacizumab for Recurrent Brain Cancer

Phase < 1
Waitlist Available
Research Sponsored by University of Texas Southwestern Medical Center
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Prior treatment with Novo-TTF therapy is allowed at initial diagnosis, but must be discontinued prior to study entry
Histologically confirmed GBM at first or second recurrence after concurrent chemoradiotherapy
Must not have
Taking any treatments listed in the Prohibited Concomitant Medications
Prior treatment with prolifeprospan 20 with carmustine wafer
Timeline
Screening 3 weeks
Treatment Varies
Follow Up upto 2 years after study treatment
Awards & highlights

Summary

This trial found that the addition of Abemaciclib to Bevacizumab was safe in patients with recurrent Glioblastoma (GBM) and specific molecular aberrations. Adverse events were similar to those seen with Bevacizumab alone.

Who is the study for?
This trial is for adults over 18 with recurrent glioblastoma brain tumors, who have specific genetic changes in their tumor. They must be able to take oral meds, have good organ function, and a performance status of at least 60%. Women of childbearing age and men with partners must use contraception.
What is being tested?
The trial tests the safety and side effects of Abemaciclib taken orally twice daily combined with Bevacizumab given intravenously every two weeks in patients whose glioblastoma has returned and shows certain molecular abnormalities.
What are the potential side effects?
Potential side effects include high blood pressure, bleeding or clotting issues, heart problems like congestive failure or angina, gastrointestinal complications such as fistulas or perforations, infections like abscesses, diabetes control issues, and allergic reactions.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
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I have used Novo-TTF therapy before but stopped before joining this study.
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My GBM has recurred 1 or 2 times after treatment with chemo and radiation.
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I am 18 years old or older.
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I can care for myself but may need occasional help.
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My GBM tumor was analyzed with advanced genetic tests and has specific changes.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:
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I am not taking any medications that are not allowed in the study.
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I have been treated with prolifeprospan 20 and carmustine wafer before.
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My high blood pressure is not well controlled.
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I have not had a brain abscess or active bacterial infection in the last 6 months.
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My heart condition is at least moderate in severity.
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I have had a severe hypertension crisis or brain issues due to high blood pressure.
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My diabetes is not under control despite taking all my medications.
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I have had a heart attack or unstable chest pain before joining the study.
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I do not have any uncontrolled illnesses.
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I have a serious wound or bone fracture that is not healing.
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I have previously been treated with specific cancer drugs like Bevacizumab or CDK4/6 inhibitors.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~upto 2 years after study treatment
This trial's timeline: 3 weeks for screening, Varies for treatment, and upto 2 years after study treatment for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.
Primary study objectives
Number of participants with adverse event
Secondary study objectives
Median Overall Survival
Median Progression Free Survival

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%
Dry mouth
14%
Platelet count decreased
14%
Weight decreased
14%
Dysgeusia
13%
Dyspnoea
12%
Abdominal pain upper
12%
Back pain
12%
Dizziness
11%
Oedema peripheral
11%
Dyspepsia
11%
Pyrexia
11%
Blood creatinine increased
10%
Pain
9%
Stomatitis
9%
Aspartate aminotransferase increased
8%
Thrombocytopenia
8%
Lacrimation increased
8%
Dehydration
8%
Dry skin
8%
Pruritus
8%
Alanine aminotransferase increased
7%
Flatulence
7%
Upper respiratory tract infection
7%
Urinary tract infection
7%
Hypokalaemia
6%
Chills
6%
Musculoskeletal chest pain
6%
Musculoskeletal pain
6%
Anxiety
5%
Gastrooesophageal reflux disease
5%
Rash
5%
Myalgia
2%
Cellulitis
2%
Pleural effusion
1%
Atypical pneumonia
1%
Gastroenteritis viral
1%
Lung infection
1%
Sepsis
1%
Fall
1%
Hip fracture
1%
Pneumonitis
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

2Treatment groups
Experimental Treatment
Group I: Safety Run-InExperimental Treatment2 Interventions
Abemaciclib 150 mg po bid PLUS Bevacizumab 10 mg/kg IV every 2 weeks, then continue treatments for 2 cycles
Group II: Abemaciclib with BevacizumabExperimental Treatment2 Interventions
Abemaciclib 100 mg po bid PLUS Bevacizumab 10 mg/kg IV every 2 weeks, then continue treatments for 2 cycles
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Abemaciclib
2019
Completed Phase 2
~1800
Bevacizumab
2013
Completed Phase 4
~5540

Find a Location

Who is running the clinical trial?

University of Texas Southwestern Medical CenterLead Sponsor
1,072 Previous Clinical Trials
1,056,252 Total Patients Enrolled
2 Trials studying Glioblastoma
60 Patients Enrolled for Glioblastoma
Edward PanLead Sponsor

Media Library

Abemaciclib (CDK4/6 Inhibitor) Clinical Trial Eligibility Overview. Trial Name: NCT04074785 — Phase < 1
Glioblastoma Research Study Groups: Abemaciclib with Bevacizumab, Safety Run-In
Glioblastoma Clinical Trial 2023: Abemaciclib Highlights & Side Effects. Trial Name: NCT04074785 — Phase < 1
Abemaciclib (CDK4/6 Inhibitor) 2023 Treatment Timeline for Medical Study. Trial Name: NCT04074785 — Phase < 1
~0 spots leftby Oct 2024
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