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GDC-0084 With Radiation Therapy for People With PIK3CA-Mutated Solid Tumor Brain Metastases or Leptomeningeal Metastases
Sponsor: Memorial Sloan Kettering Cancer Center
Summary
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.
Official title: 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
Key Details
Gender
All
Age Range
18 Years - Any
Study Type
INTERVENTIONAL
Enrollment
21
Start Date
2019-12-06
Completion Date
2026-12
Last Updated
2025-04-17
Healthy Volunteers
No
Interventions
GDC-0084
GDC-0084 in 3 + 3 dose-escalation in 3 cohorts: 45, 60, 75 mg daily
whole brain radiation therapy radiation
30Gy in 10 fractions
Locations (9)
BAPTIST ALLIANCE - MCI (Data Collection Only)
Miami, Florida, United States
Memorial Sloan Kettering Basking Ridge (Consent only)
Basking Ridge, New Jersey, United States
Memorial Sloan Kettering Monmouth (All protocol activities)
Middletown, New Jersey, United States
Memorial Sloan Kettering Bergen (Consent only)
Montvale, New Jersey, United States
Memorial Sloan Kettering Commack (Consent only)
Commack, New York, United States
Memorial Sloan Kettering Westchester (All protocol activities)
Harrison, New York, United States
Memorial Sloan Kettering Cancer Center (All protocol activities)
New York, New York, United States
Memorial Sloan Kettering Nassau (Consent only)
Uniondale, New York, United States
University of Washington (Data Collection AND Data Analysis)
Seattle, Washington, United States