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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
Timeline
Screening 3 weeks
Treatment Varies
Follow Up upto 2 years after study treatment
Awards & highlights
Study 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.Check my eligibility
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.See study design
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 belowSelect...
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.
Select...
I am 18 years old or older.
Select...
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.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ upto 2 years after study treatment
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~upto 2 years after study treatment
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
Number of participants with adverse event
Secondary outcome measures
Median Overall Survival
Median Progression Free Survival
Side effects data
From 2018 Phase 2 trial • 132 Patients • NCT0210249091%
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
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
~1710
Bevacizumab
2013
Completed Phase 4
~5280
Find a Location
Who is running the clinical trial?
University of Texas Southwestern Medical CenterLead Sponsor
1,050 Previous Clinical Trials
1,054,349 Total Patients Enrolled
2 Trials studying Glioblastoma
60 Patients Enrolled for Glioblastoma
Edward PanLead Sponsor
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- You have a condition that makes you bleed easily or affects your blood's ability to clot.You have had bleeding in your brain recently as shown on a recent MRI.I had surgery recently for a returning or worsening tumor and meet certain conditions.I have used Novo-TTF therapy before but stopped before joining this study.I am a male willing to use contraception for 6 months after treatment if my partner is of childbearing age.I can swallow pills.I haven't had major blood vessel problems in the last 6 months.You are allergic to Chinese hamster ovary cell products or other types of engineered antibodies.I am not taking any medications that are not allowed in the study.I have not had a stroke or mini-stroke in the last 6 months.I have been treated with prolifeprospan 20 and carmustine wafer before.My high blood pressure is not well controlled.My organs and bone marrow are working well.I have recovered from the side effects of my last chemotherapy.My GBM has recurred 1 or 2 times after treatment with chemo and radiation.Your blood test results are not within the normal range.I have not had a brain abscess or active bacterial infection in the last 6 months.I have not had a gut perforation or abnormal connection in my belly in the last 6 months.My heart condition is at least moderate in severity.I am using birth control during and 6 months after treatment.I am 18 years old or older.You cannot have a special kind of MRI scan with a contrast dye injected into your veins.I have had a severe hypertension crisis or brain issues due to high blood pressure.I can care for myself but may need occasional help.My diabetes is not under control despite taking all my medications.I have had a heart attack or unstable chest pain before joining the study.You are currently taking other experimental medications.I do not have any uncontrolled illnesses.My steroid dose has been stable or decreasing for the last 5 days.I have a serious wound or bone fracture that is not healing.I have had cancer before, but I've been cancer-free for less than 3 years.My GBM tumor was analyzed with advanced genetic tests and has specific changes.Your medical images show that your tumor has started growing again according to specific criteria.I have previously been treated with specific cancer drugs like Bevacizumab or CDK4/6 inhibitors.
Research Study Groups:
This trial has the following groups:- Group 1: Abemaciclib with Bevacizumab
- Group 2: Safety Run-In
Awards:
This trial has 1 awards, including:- No Placebo-Only Group - All patients enrolled in this study will receive some form of active treatment.
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.
Frequently Asked Questions
These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.
In what type of medical treatments is Abemaciclib most commonly employed?
"Abemaciclib has been proven to be effective in treating malignant neoplasms, recurrent platinum sensitive primary peritoneal cancer, and stage IV epithelial ovarian cancer following initial surgical resection."
Answered by AI
Does this research program preclude those who are octogenarian or younger?
"This clinical trial only includes adults between the ages of 18 and 99. However, there are other trials available for minors under eighteen or seniors over sixty-five with 274 studies centred around children and 1983 research projects focused on geriatric patients."
Answered by AI
Has Abemaciclib been evaluated in any previous clinical trials?
"Presently, there are over 400 active clinical trials involving Abemaciclib with more than a hundred in Phase 3. Most of these studies are based out of Nantong, Jiangsu but the drug is being trialled at nearly 25K locations worldwide."
Answered by AI
What is the upper limit of participants enrolled in this clinical trial?
"This clinical trial has already finished recruiting and is no longer active. It was first posted on December 13th 2019, with the last update being January 23rd 2022. However, there are currently 1,739 studies open for enrollment of patients with glioblastoma and 442 trials actively looking for participants to take Abemaciclib."
Answered by AI
How can I qualify for this research endeavor?
"This trial seeks 10 participants with glioblastoma aged 18-99 who meet the following criteria: amplification of CDK4/6, male partners have to agree on using a barrier method of contraception during treatment and at least 6 months after, no hysterectomy or bilateral oophorectomy; natural postmenopausal status for 12 consecutive months prior to enrollment. Surgery must confirm recurrence."
Answered by AI
Are there still openings available for enrolment in this clinical trial?
"This trial is currently not enrolling participants, having been first posted on December 13th 2019 and last updated on January 23rd 2022. However, those searching for clinical trials related to glioblastoma have 1739 options while 442 research studies are presently seeking patients taking Abemaciclib."
Answered by AI
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