Abemaciclib + Bevacizumab for Recurrent Brain Cancer

Recruiting in Palo Alto (17 mi)

Age: 18+

Sex: Any

Travel: May be covered

Time Reimbursement: Varies

Trial Phase: Phase < 1

Waitlist Available

Sponsor: University of Texas Southwestern Medical Center

No Placebo Group

Breakthrough Therapy

Trial Summary

What is the purpose of this trial?Describe the safety and adverse events associated with Abemaciclib 150 mg orally twice daily when administered with Bevacizumab 10 mg/kg intravenously every 2 weeks to recurrent GBM patients with specific tumor molecular aberrations

Eligibility Criteria

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.

Inclusion Criteria

I have used Novo-TTF therapy before but stopped before joining this study.

My GBM has recurred 1 or 2 times after treatment with chemo and radiation.

I am 18 years old or older.

I can care for myself but may need occasional help.

My GBM tumor was analyzed with advanced genetic tests and has specific changes.

Exclusion Criteria

I am not taking any medications that are not allowed in the study.

I have been treated with prolifeprospan 20 and carmustine wafer before.

My high blood pressure is not well controlled.

I have not had a brain abscess or active bacterial infection in the last 6 months.

My heart condition is at least moderate in severity.

I have had a severe hypertension crisis or brain issues due to high blood pressure.

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.

I do not have any uncontrolled illnesses.

I have a serious wound or bone fracture that is not healing.

I have previously been treated with specific cancer drugs like Bevacizumab or CDK4/6 inhibitors.

Participant Groups

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.

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

Abemaciclib is already approved in United States, European Union for the following indications:

🇺🇸 Approved in United States as Verzenio for:

Hormone receptor-positive (HR+), human epidermal growth factor receptor 2 (HER2)-negative advanced or metastatic breast cancer
HR+, HER2- node-positive early breast cancer

🇪🇺 Approved in European Union as Verzenio for: