4 recruiting, 3 completed, 1 active not recruiting, 1 terminated. 6 Phase 2, 4 Phase 1, 1 Phase 3.
| Phase | Trials | Status |
|---|---|---|
| Phase 2 | 6 | Recruiting 4, Completed 1, Terminated 1 |
| Phase 1 | 4 | Completed 2, Active not recruiting 1, Recruiting 1 |
| Phase 3 | 1 | Recruiting 1 |
Follow GDC-0084: new trials by email Literature Review of GDC-0084 trials Research Report on GDC-0084
Tick up to 5 trials to compare them side by side (eligibility, arms, endpoints, adverse events) in a Literature Matrix.
| Trial | Phase | Status | Sponsor | Enrollment | Start | Updated |
|---|---|---|---|---|---|---|
| 5G-PEARL: Paxalisib in Malignant Brain Tumours Paxalisib, Temozolomide capsule - Malignant Primary Gliomas, Glioblastoma Multiforme (GBM) | Phase 1 / Phase 2 | Recruiting | Institute of Cancer Research, United Kingdom | 64 | 2026-01-19 | 2026-02-05 |
| Combination Therapy for the Treatment of Diffuse Midline Gliomas ONC201, Radiation Therapy, Paxalisib - Diffuse Intrinsic Pontine Glioma, Diffuse Midline Glioma, H3 K27M-Mutant | Phase 2 | Recruiting | University of California, San Francisco | 360 | 2021-10-20 | 2026-06-26 |
| Paxalisib (GDC-0084) In Recurrent Or Refractory PCNSL PAXALISIB - Primary Central Nervous System Lymphoma, Non-Hodgkin Lymphoma of Extranodal Site | Phase 2 | Recruiting | Lakshmi Nayak, MD | 25 | 2021-06-01 | 2026-08-05 |
| GDC-0084 With Radiation Therapy for People With PIK3CA-Mutated Solid Tumor Brain Metastases or Leptomeningeal Metastases GDC-0084, whole brain radiation therapy radiation - Brain Metastases, Leptomeningeal Metastasis | Phase 1 | Active not recruiting | Memorial Sloan Kettering Cancer Center | 21 | 2019-12-06 | 2026-04-22 |
| A Trial to Evaluate Multiple Regimens in Newly Diagnosed and Recurrent Glioblastoma Temozolomide, Lomustine, Regorafenib - Glioblastoma | Phase 2 / Phase 3 | Recruiting | Global Coalition for Adaptive Research | 2250 | 2019-07-30 | 2026-10-23 |
| GDC-0084 in Combination With Trastuzumab for Patients With HER2-Positive Breast Cancer Brain Metastases Trastuzumab, GDC-0084 - Breast Cancer | Phase 2 | Terminated | Dana-Farber Cancer Institute | 17 | 2019-02-25 | 2026-05-27 |
| Study of GDC-0084 in Pediatric Patients With Newly Diagnosed Diffuse Intrinsic Pontine Glioma or Diffuse Midline Gliomas GDC-0084, radiation therapy - Brain and Central Nervous System Tumors | Phase 1 | Completed | St. Jude Children's Research Hospital | 27 | 2018-11-19 | 2023-01-18 |
| Safety, Pharmacokinetics and Efficacy of Paxalisib (GDC-0084) in Newly-diagnosed Glioblastoma Paxalisib (GDC-0084) - Glioblastoma, Adult | Phase 2 | Completed | Kazia Therapeutics Limited | 30 | 2018-05-15 | 2025-03-24 |
| A Study of GDC-0084 in Patients With Progressive or Recurrent High-Grade Glioma GDC-0084 - Glioblastoma, Glioma | Phase 1 | Completed | Genentech, Inc. | 29 | 2012-04-01 | 2016-11-02 |
Glioblastoma (5) · Brain Neoplasms (2) · Diffuse Intrinsic Pontine Glioma (2) · Astrocytoma (1) · Breast Neoplasms (1) · Central Nervous System Neoplasms (1) · Glioma (1) · Meningeal Carcinomatosis (1) · Recurrence (1)
Dana-Farber Cancer Institute (1) · Genentech, Inc. (1) · Global Coalition for Adaptive Research (1) · Institute of Cancer Research, United Kingdom (1) · Kazia Therapeutics Limited (1) · Lakshmi Nayak, MD (1) · Memorial Sloan Kettering Cancer Center (1) · St. Jude Children's Research Hospital (1) · University of California, San Francisco (1)
United States (8) · Australia (2) · Switzerland (2) · Canada (1) · France (1) · Germany (1) · Israel (1) · Netherlands (1) · New Zealand (1) · Spain (1) · United Kingdom (1)
Amar Gajjar, MD (1) · Brandon Imber, MD, PhD (1) · Christopher Tinkle, MD, PhD (1) · James Garner, MD (1) · Jose P Leone, MD (1) · Juanita Lopez, MD, PhD (1) · Lakshmi Nayak, MD (1) · Sabine Mueller, MD, PhD (1) · Tim Cloughesy, MD (1)
PMID 31937616, PMID 32269051, PMID 35157764, PMID 37195023, PMID 38773224, PMID 41980234
R01NS124607 (1)