GDC-0084 With Radiation Therapy for People With PIK3CA-Mutated Solid Tumor Brain Metastases or Leptomeningeal Metastases (NCT04192981)
A Phase I Study With Expansion Cohort of Concurrent GDC-0084 With Radiation Therapy for Patients With Solid Tumor Brain Metastases or Leptomeningeal Metastases Harboring PI3K Pathway Mutations
🩺 Plain-English Summary (8th-Grade Level)
This study will test the safety of the study drug, GDC-0084, in combination with radiation therapy in people who have solid tumor brain metastases or leptomeningeal metastases. All participants will have cancer with a PIK3CA mutation. The researchers will test increasing doses of GDC-0084 to find the highest dose that causes few or mild side effects in participants. The study will also try to find out if the combination of the study drug with radiation is effective against participants' cancer.
Who can join: Review the eligibility criteria below.
Location: BAPTIST ALLIANCE - MCI (Data Collection Only) — Miami, Florida
Age range: 18 Years
🧪 Interventions in This Study
📋 "Do I Qualify?" — 1-Minute Self Screener
Instant ChecklistFull eligibility criteria are available on the official NIH protocol. View the criteria ↗
📍 All Participating Trial Locations (9 Sites)
- BAPTIST ALLIANCE - MCI (Data Collection Only) — Miami, Florida
- Memorial Sloan Kettering Basking Ridge (Consent only) — Basking Ridge, New Jersey
- Memorial Sloan Kettering Monmouth (All protocol activities) — Middletown, New Jersey
- Memorial Sloan Kettering Bergen (Consent only) — Montvale, New Jersey
- Memorial Sloan Kettering Commack (Consent only) — Commack, New York
- Memorial Sloan Kettering Westchester (All protocol activities) — Harrison, New York
- Memorial Sloan Kettering Cancer Center (All protocol activities) — New York, New York
- Memorial Sloan Kettering Nassau (Consent only) — Uniondale, New York
- University of Washington (Data Collection AND Data Analysis) — Seattle, Washington
💰 Cost, Insurance & Patient Rights
- 100% Free Items: The investigational treatment and protocol-required procedures are supplied at zero cost by the sponsor.
- Routine Patient Care: Under federal law (ACA § 2709) and many state statutes, routine care costs are covered during participation.
- Voluntary Participation: You may withdraw at any time without affecting your standard medical care.
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💡 How to Participate
- Check the checklist above to see if you may qualify.
- Review the official NIH record below to find the coordinating site.
- Ask about the visit schedule, what is covered at no cost, and any travel support.
- Confirm with your own doctor before making a decision.