GDC-0084 + Radiation for Brain Cancer

Recruiting in Palo Alto (17 mi)

+11 other locations

Brandon Imber, MD, MA - MSK Radiation ...

Overseen byT. Jonathan Yang, MD, PhD

Age: 18+

Sex: Any

Travel: May Be Covered

Time Reimbursement: Varies

Trial Phase: Phase 1

Waitlist Available

Sponsor: Memorial Sloan Kettering Cancer Center

No Placebo Group

Trial Summary

What is the purpose of this trial?This trial is testing a new drug, GDC-0084, combined with radiation therapy for people whose brain cancer has a specific genetic mutation. The goal is to find the safest dose and see if this combination treatment works better against their cancer.

Eligibility Criteria

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.

Inclusion Criteria

Patient at reproductive potential must agree to practice an effective contraceptive method

My kidneys are working well.

I finished my last cancer treatment more than a week ago.

+12 more

Exclusion Criteria

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.

+7 more

Participant Groups

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.

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.