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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 below

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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

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.

Treatment

First Studied

Drug Approval Stage

How many patients have taken this drug

GDC-0084

Not yet FDA approved

0 / 8Eligibility criteria met

Find a Location

Who is running the clinical trial?

Kazia TherapeuticsUNKNOWN

Memorial Sloan Kettering Cancer CenterLead Sponsor

1,933 Previous Clinical Trials

585,358 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

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

Does this research endeavor have vacancies for participants?

"The clinicaltrials.gov database shows that this medical trial is presently recruiting candidates; it was first launched on December 6th 2019 and has been revised as recently as October 5th 2022."

Answered by AI

What other research initiatives have been undertaken to explore the efficacy of GDC-0084?

"GDC-0084 was first investigated by St. Jude Children's Research Hospital in 2018, and a single clinical trial has been completed since then. Now there are 6 active recruiting studies taking place across the area of Middletown, New jersey."

Answered by AI

How many establishments are responsible for the management of this clinical trial?

"Currently, 8 clinical trial sites are available for this medical study including Memorial Sloan Kettering Monmouth (for all protocol activities) in Middletown, Memoral Sloan Kettering Basking Ridge (Consent only) in Basking Ridge and the flagship one -Memorial Sloan Kettering Cancer Center (All protocol activities)- located in New york. Additionally there are 5 other locations providing services related to this project."

Answered by AI

Is this investigation an innovative endeavor?

"GDC-0084 has been under investigation since 2018, when Kazia Therapeutics Limited sponsored the first trial with 27 participants. Subsequently obtaining Phase 1 approval, GDC-0084 is now being studied in 6 trials across 7 countries and 52 cities."

Answered by AI

Could you elucidate the safety profile of GDC-0084 for those receiving treatment?

"The safety of GDC-0084 was rated at a 1 due to this being an initial Phase 1 trial, thus there is limited data that can attest to its efficacy and overall security."

Answered by AI

How many subjects have been recruited to participate in this research?

"Correct. Clinicaltrials.gov displays evidence that this clinical study, which was initially shared on December 6th 2019, is still recruiting individuals for participation. 36 volunteers are needed across 8 sites."

Answered by AI

Recent research and studies

clinicaltrials.govStudy

GDC-0084 With Radiation Therapy for People With PIK3CA-Mutated Solid Tumor Brain Metastases or Leptomeningeal Metastases

2019. "GDC-0084 With Radiation Therapy for People With PIK3CA-Mutated Solid Tumor Brain Metastases or Leptomeningeal Metastases". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT04192981.

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