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ACTIVE NOT RECRUITING
NCT04192981
PHASE1

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

Sponsor: Memorial Sloan Kettering Cancer Center

View on ClinicalTrials.gov

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

DRUG

GDC-0084

GDC-0084 in 3 + 3 dose-escalation in 3 cohorts: 45, 60, 75 mg daily

RADIATION

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