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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
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 1 year
Awards & highlights
Study Summary
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 belowSelect...
I am mostly able to care for myself.
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My bone marrow is working well.
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My seizures caused by brain cancer are under control with medication.
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I can swallow and keep down pills.
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My cancer has spread to my brain, confirmed by an MRI.
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I am 18 years old or older.
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My cancer has a PIK3CA mutation.
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I take less than 4mg of dexamethasone daily.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ 1 year
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~1 year
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.
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
GDC-0084
Not yet FDA approved
Find a Location
Who is running the clinical trial?
Kazia TherapeuticsUNKNOWN
Memorial Sloan Kettering Cancer CenterLead Sponsor
1,940 Previous Clinical Trials
588,890 Total Patients Enrolled
T. Jonathan Yang, MD, PhDPrincipal InvestigatorMemorial Sloan Kettering Cancer Center
3 Previous Clinical Trials
271 Total Patients Enrolled
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- I am allergic or have had a bad reaction to GDC-0084 or similar medications.My kidneys are working well.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 finished my last cancer treatment more than a week ago.My liver is working well.I have had lung conditions that needed steroid treatment.I am not taking drugs that strongly affect how my body processes certain medications.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 organ functions are within normal ranges according to recent tests.My cancer has spread to my brain, confirmed by an MRI.I have heart problems.I am eligible for a specific type of brain radiation therapy.Your heart's QT interval is longer than 450 milliseconds on an EKG test.I am 18 years old or older.My cancer has a PIK3CA mutation.I take insulin for my diabetes.I take less than 4mg of dexamethasone daily.I have new brain lesions or leptomeningeal metastases not previously treated with radiation.
Research Study Groups:
This trial has the following groups:- Group 1: Concurrent GDC-0084 with Radiation
Awards:
This trial has 1 awards, including:- No Placebo-Only Group - All patients enrolled in this study will receive some form of active treatment.
Timeline:
This trial has the following timeline:- 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.
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