Spots Global Cancer Trial Database for GDC-0084 With Radiation Therapy for People With PIK3CA-Mutated Solid Tumor Brain Metastases or Leptomeningeal Metastases
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Trial Identification
Brief Title: GDC-0084 With Radiation Therapy for People With PIK3CA-Mutated Solid Tumor Brain Metastases or Leptomeningeal Metastases
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
Study ID: NCT04192981
Study Description
Brief 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.
Detailed Description:
Eligibility
Minimum Age: 18 Years
Eligible Ages: ADULT, OLDER_ADULT
Sex: ALL
Healthy Volunteers: No
Locations
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
Contact Details
Name: Brandon Imber, MD, PhD
Affiliation: Memorial Sloan Kettering Cancer Center
Role: PRINCIPAL_INVESTIGATOR
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