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GDC-0084

DRUG4 trials

Sponsors

Genentech, Inc., St. Jude Children's Research Hospital, Dana-Farber Cancer Institute, Memorial Sloan Kettering Cancer Center

Conditions

Brain MetastasesBrain and Central Nervous System TumorsBreast CancerGlioblastoma, GliomaLeptomeningeal Metastasis

Phase 1

A Study of GDC-0084 in Patients With Progressive or Recurrent High-Grade Glioma
CompletedNCT01547546
Genentech, Inc.Glioblastoma, Glioma
Start: 2012-04-30End: 2015-01-31Updated: 2016-11-02
Study of GDC-0084 in Pediatric Patients With Newly Diagnosed Diffuse Intrinsic Pontine Glioma or Diffuse Midline Gliomas
CompletedNCT03696355
St. Jude Children's Research HospitalBrain and Central Nervous System Tumors
Start: 2018-11-19End: 2022-09-04Updated: 2023-01-18
GDC-0084 With Radiation Therapy for People With PIK3CA-Mutated Solid Tumor Brain Metastases or Leptomeningeal Metastases
Active, not recruitingNCT04192981
Memorial Sloan Kettering Cancer CenterBrain Metastases, Leptomeningeal Metastasis
Start: 2019-12-06End: 2026-12-01Updated: 2026-04-22

Phase 2

GDC-0084 in Combination With Trastuzumab for Patients With HER2-Positive Breast Cancer Brain Metastases
TerminatedNCT03765983
Dana-Farber Cancer InstituteBreast Cancer
Start: 2019-02-25End: 2024-05-14Updated: 2026-05-27

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Abstract CT205: Phase 2 study to evaluate the safety, pharmacokinetics, and clinical activity of the PI3K / mTOR inhibitor paxalisib (GDC-0084) in glioblastoma (GBM) with unmethylated O6-methylguanine-methyltransferase (MGMT) promotor status
Cancer Research2020-08-152 citations
Abstract CT252: A dose escalation phase I study of concurrent GDC-0084 with radiation therapy for patients with solid tumor brain metastases or leptomeningeal metastases harboring PI3K pathway mutations
Cancer Research2020-08-151 citations
Escalation portion of phase II study to evaluate the safety, pharmacokinetics, and clinical activity of the PI3K/mTOR inhibitor paxalisib (GDC-0084) in glioblastoma (GBM) with unmethylated O6-methylguanine-methyltransferase (MGMT) promotor status.
Journal of Clinical Oncology2020-05-206 citations
Multiparametric MR-PET Imaging Predicts Pharmacokinetics and Clinical Response to GDC-0084 in Patients with Recurrent High-Grade Glioma
Clinical Cancer Research2020-04-0811 citations
Abstract OT1-08-05: Phase II trial of GDC-0084 in combination with trastuzumab for patients with HER2-positive breast cancer brain metastases (BCBM)
Cancer Research2020-02-15
NIMG-34. MULTI-PARAMETRIC MR-PET IMAGING PREDICTS PHARMACOKINETICS AND CLINICAL RESPONSE TO GDC-0084 IN HUMAN RECURRENT HIGH-GRADE GLIOMA
Neuro-Oncology2019-11-01
TRLS-03. PHASE II TRIAL OF GDC-0084 IN COMBINATION WITH TRASTUZUMAB FOR PATIENTS WITH HER2-POSITIVE BREAST CANCER BRAIN METASTASES (BCBM)
Neuro-Oncology Advances2019-08-013 citations
ACTR-51. PHASE 2 STUDY TO EVALUATE THE SAFETY, PHARMACOKINETICS AND CLINICAL ACTIVITY OF PI3K/MTOR INHIBITOR GDC-0084 GIVEN TO GLIOBLASTOMA (GBM) PATIENTS WITH UNMETHYLATED O6-METHYLGUANINE-METHYLTRANSFERASE PROMOTER STATUS
Neuro-Oncology2018-11-01
A first-in-human phase 1 study to evaluate the brain-penetrant PI3K/mTOR inhibitor GDC-0084 in patients with progressive or recurrent high-grade glioma.
Journal of Clinical Oncology2016-05-2016 citations