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CDK4/6 Inhibitor

LY3214996 + Abemaciclib for Glioblastoma

Phase < 1

Recruiting

Led By Nader Sanai, MD

Research Sponsored by Nader Sanai

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Be older than 18 years old

Timeline

Screening 3 weeks

Treatment Varies

Follow Up up to 60 months

Awards & highlights

No Placebo-Only Group

Summary

This trial is testing a new cancer treatment on 50 people with recurrent glioblastoma. The treatment will be given before surgery to remove the tumor.

Who is the study for?

This trial is for adults over 18 with recurrent glioblastoma who've had prior treatment including surgery, temozolomide, and radiotherapy. They must have measurable disease, specific genetic features in their tumor tissue, and be able to swallow pills. Pregnant or breastfeeding individuals can't join; neither can those with certain heart conditions, severe infections or liver diseases, a history of blood clots in the eye causing vision loss, or those on coumarin anticoagulants.

What is being tested?

The trial tests LY3214996 plus Abemaciclib given before surgical removal of brain tumors in patients with recurrent glioblastoma. Initially up to 10 participants will receive this combination therapy; if successful based on PK results from Phase 0 and enrollment into Phase 2 reaches at least five participants, around 40 more may join for further evaluation.

What are the potential side effects?

Potential side effects include reactions related to liver function changes (like jaundice), fatigue due to low red blood cell counts (anemia), increased risk of infection from white blood cell changes (neutropenia), bleeding issues due to low platelets (thrombocytopenia), digestive disturbances such as diarrhea or nausea.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ up to 60 months

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~up to 60 months

This trial's timeline: 3 weeks for screening, Varies for treatment, and up to 60 months for reporting.

Treatment Details

Study Objectives

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

Primary study objectives

Pharmacokinetic analysis of plasma

Phase 0: Pharmacokinetic analysis of cerebrospinal fluid (CSF)

Phase 0: Pharmacokinetic analysis of tumor tissue

+1 more

Secondary study objectives

Deaths

Incidence of clinical laboratory abnormalities per CTCAE

Incidence of drug-related toxicity

+3 more

Awards & Highlights

No Placebo-Only Group

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

Trial Design

1Treatment groups

Experimental Treatment

Group I: Arm 1Experimental Treatment2 Interventions

400 mg of LY3214996 QD for 6 doses and 100 mg of Abemaciclib BID for 11 doses over 5.5 days prior to surgical resection. On Day 6, participants will receive Abemaciclib + LY3214996 dose 7 to 9 hours prior to craniotomy for tumor resection.

Treatment

First Studied

Drug Approval Stage

How many patients have taken this drug

Abemaciclib

2019

Completed Phase 2

~1890

LY3214996

2019

Completed Phase 2

~270