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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

Must not have

Participants who have received anti-VEGF targeted agents

Participants with IDH1/2 mutation in any prior biopsy

Timeline

Screening 3 weeks

Treatment Varies

Follow Up 2 years

Awards & highlights

No Placebo-Only Group

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.

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.

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.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:

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I have been treated with drugs targeting VEGF.

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My cancer has an IDH1 or IDH2 mutation.

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I have been treated with a CDK4/6 inhibitor before.

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My tumor has a 1p/19q co-deletion.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ 2 years

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

Study objectives can provide a clearer picture of what you can expect from a treatment.

Secondary study objectives

Area under the plasma concentration versus time curve (AUC)

Incidence of Treatment-Emergent Adverse Events

Peak Plasma Concentration (Cmax)

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

Stomatitis

Aspartate aminotransferase increased

Thrombocytopenia

Lacrimation increased

Dehydration

Dry skin

Pruritus

Alanine aminotransferase increased

Flatulence

Upper respiratory tract infection

Urinary tract infection

Hypokalaemia

Chills

Musculoskeletal chest pain

Musculoskeletal pain

Anxiety

Gastrooesophageal reflux disease

Rash

Myalgia

Cellulitis

Pleural effusion

Atypical pneumonia

Gastroenteritis viral

Lung infection

Sepsis

Fall

Hip fracture

Pneumonitis

Pneumothorax

Febrile neutropenia

Respiratory tract infection

Haematotoxicity

Sinus bradycardia

Tachycardia

Large intestinal obstruction

Pancreatic enzyme abnormality

Pancreatitis

Varices oesophageal

Electrocardiogram abnormal

Liver function test abnormal

Renal function test abnormal

Bone pain

Muscular weakness

Acute kidney injury

Pulmonary embolism

Arterial thrombosis

Epilepsy

100%

80%

60%

40%

20%

Study treatment Arm

Abemaciclib

Awards & Highlights

No Placebo-Only Group

All patients enrolled in this study will receive some form of active treatment.

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

~2490

Abemaciclib

2019

Completed Phase 2

~1890