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PI3K Inhibitor

GDC-0084 + Radiation for Brain Cancer

Phase 1
Waitlist Available
Led By T. Jonathan Yang, MD, PhD
Research Sponsored by Memorial Sloan Kettering Cancer Center
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
KPS ≥ 70
Adequate bone marrow function
Must not have
Known hypersensitivity or intolerance to GDC-0084 or to any other inhibitor of the PI3K/ Akt/ mTOR pathway
Previous radiotherapy to the intended treatment site that precludes developing a treatment plan that respects tissue tolerances
Screening 3 weeks
Treatment Varies
Follow Up 1 year
Awards & highlights


This trial will test the safety of GDC-0084 in combination with radiation therapy in people with brain or leptomeningeal cancer with a PIK3CA mutation. Researchers will try to find the highest dose of the drug that causes few or mild side effects in participants, as well as if the combination is effective against cancer.

Who is the study for?
This trial is for adults with solid tumor brain metastases or leptomeningeal metastases, specifically those with a PIK3CA mutation. Participants must be over 18, able to consent, have good performance status (KPS ≥ 70), and can swallow pills. They should not have had recent systemic therapy and must use effective contraception if of reproductive potential.Check my eligibility
What is being tested?
The study is testing the safety and effectiveness of GDC-0084 when combined with whole brain radiation therapy in treating cancer that has spread to the brain. It aims to determine the highest dose of GDC-0084 that causes few or mild side effects.See study design
What are the potential side effects?
Potential side effects may include issues related to organ inflammation such as interstitial lung disease, problems from drug interactions affecting metabolism, heart rhythm abnormalities (QT interval prolongation), and general intolerance or allergic reactions to components of GDC-0084.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
I am mostly able to care for myself.
My bone marrow is working well.
My seizures caused by brain cancer are under control with medication.
I can swallow and keep down pills.
My cancer has spread to my brain, confirmed by an MRI.
I am 18 years old or older.
My cancer has a PIK3CA mutation.
I take less than 4mg of dexamethasone daily.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:
I am allergic or have had a bad reaction to GDC-0084 or similar medications.
I've had radiation before where they now want to treat, and can't have more without risking harm.
I have health conditions that prevent me from receiving radiation therapy.
I have had lung conditions that needed steroid treatment.
I am not taking drugs that strongly affect how my body processes certain medications.
I have heart problems.
I am eligible for a specific type of brain radiation therapy.
I take insulin for my diabetes.


Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~1 year
This trial's timeline: 3 weeks for screening, Varies for treatment, and 1 year for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
maximum tolerated dose (MTD)
Secondary outcome measures
local recurrence rate

Trial Design

1Treatment groups
Experimental Treatment
Group I: Concurrent GDC-0084 with RadiationExperimental Treatment2 Interventions
GDC-0084 in 3 + 3 dose-escalation in 3 cohorts: 45, 60, 75 mg daily, with a potential de-escalation cohort to 30mg, to determine MTD in combination with whole brain radiation therapy radiation therapy to 30Gy in 10 fractions. Once MTD is determined, 12 additional patients will be treated with GDC-0084 at MTD in combination with whole brain radiation therapy.
First Studied
Drug Approval Stage
How many patients have taken this drug
Not yet FDA approved

Research Highlights

Information in this section is not a recommendation. We encourage patients to speak with their healthcare team when evaluating any treatment decision.
Mechanism Of Action
Side Effect Profile
Prior Approvals
Other Research
Common treatments for brain tumors include PI3K/mTOR inhibitors like GDC-0084, which target the PI3K/mTOR pathway involved in cell growth and survival, thereby inhibiting tumor progression. Temozolomide, an alkylating agent, works by damaging the DNA of cancer cells, leading to cell death. Bevacizumab, an anti-angiogenic drug, inhibits the formation of new blood vessels that tumors need to grow. These treatments are crucial for brain tumor patients as they target specific pathways and mechanisms essential for tumor growth and survival, potentially improving outcomes and providing more personalized therapeutic options.
Bioinformatics analysis reveals potential candidate drugs for different subtypes of glioma.

Find a Location

Who is running the clinical trial?

Kazia TherapeuticsUNKNOWN
Memorial Sloan Kettering Cancer CenterLead Sponsor
1,944 Previous Clinical Trials
589,730 Total Patients Enrolled
T. Jonathan Yang, MD, PhDPrincipal InvestigatorMemorial Sloan Kettering Cancer Center
3 Previous Clinical Trials
271 Total Patients Enrolled

Media Library

GDC-0084 (PI3K Inhibitor) Clinical Trial Eligibility Overview. Trial Name: NCT04192981 — Phase 1
Brain Tumor Research Study Groups: Concurrent GDC-0084 with Radiation
Brain Tumor Clinical Trial 2023: GDC-0084 Highlights & Side Effects. Trial Name: NCT04192981 — Phase 1
GDC-0084 (PI3K Inhibitor) 2023 Treatment Timeline for Medical Study. Trial Name: NCT04192981 — Phase 1
~5 spots leftby Dec 2025