NCT04192981View on ClinicalTrials.gov

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

PHASE1Active, not recruitingINTERVENTIONAL
Enrollment

21

Participants

Timeline

Start Date

December 6, 2019

Primary Completion Date

December 31, 2026

Study Completion Date

December 31, 2026

Conditions
Brain MetastasesLeptomeningeal Metastasis
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

Trial Locations (9)

10065

Memorial Sloan Kettering Cancer Center (All protocol activities), New York

10604

Memorial Sloan Kettering Westchester (All protocol activities), Harrison

11553

Memorial Sloan Kettering Nassau (Consent only), Uniondale

11725

Memorial Sloan Kettering Commack (Consent only), Commack

33143

BAPTIST ALLIANCE - MCI (Data Collection Only), Miami

98109

University of Washington (Data Collection AND Data Analysis), Seattle

07920

Memorial Sloan Kettering Basking Ridge (Consent only), Basking Ridge

07748

Memorial Sloan Kettering Monmouth (All protocol activities), Middletown

07645

Memorial Sloan Kettering Bergen (Consent only), Montvale

Sponsors

Collaborators (1)

Kazia Therapeutics
All Listed Sponsors
collaborator

Kazia Therapeutics

UNKNOWN

lead

Memorial Sloan Kettering Cancer Center

OTHER