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Abemaciclib + Bevacizumab for Recurrent Brain Cancer
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.
Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowTimeline
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Side effects data
From 2018 Phase 2 trial • 132 Patients • NCT02102490Trial Design
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- 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.
- Group 1: Abemaciclib with Bevacizumab
- Group 2: Safety Run-In
- No Placebo-Only Group - All patients enrolled in this study will receive some form of active treatment.
- 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
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."
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."
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."
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."
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."
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."
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