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| ID | Type | Description | Link |
|---|---|---|---|
| 2011-004479-35 | EudraCT Number |
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This open-label, multicenter, Phase I, dose-escalating study will evaluate the safety and tolerability, pharmacokinetics, pharmacodynamics and efficacy of GDC-0084 in patients with progressive or recurrent high-grade glioma. Stage 1 is the dose escalation part of the study. Stage 2, patients will receive GDC-0084 at a recommended dose for future studies.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Single Arm | Experimental |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| GDC-0084 | Drug | Multiple doses |
|
| Measure | Description | Time Frame |
|---|---|---|
| Safety: Incidence of adverse events | approximately 2 years | |
| Maximum tolerated dose (MTD) | approximately 1 year |
| Measure | Description | Time Frame |
|---|---|---|
| Pharmacokinetics: Area under the concentration-time curve | Pre- and post-dose Days 1, 8, 15, 22 and 29 Cycle 1, Day 1 every following Cycle until 30 days after the last dose of study drug | |
| Best overall response rate, tumor assessments according to Response Assessment in Neuro-Oncology (RANO) |
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Inclusion Criteria:
Patients enrolled in Stage 1:
Patients enrolled in Stage 2:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Clinical Trials | Genentech, Inc. | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Los Angeles | California | 90095 | United States | |||
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 32269051 | Derived | Ellingson BM, Yao J, Raymond C, Nathanson DA, Chakhoyan A, Simpson J, Garner JS, Olivero AG, Mueller LU, Rodon J, Gerstner E, Cloughesy TF, Wen PY. Multiparametric MR-PET Imaging Predicts Pharmacokinetics and Clinical Response to GDC-0084 in Patients with Recurrent High-Grade Glioma. Clin Cancer Res. 2020 Jul 1;26(13):3135-3144. doi: 10.1158/1078-0432.CCR-19-3817. Epub 2020 Apr 8. | |
| 31937616 |
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| ID | Term |
|---|---|
| D005909 | Glioblastoma |
| D005910 | Glioma |
| ID | Term |
|---|---|
| D001254 | Astrocytoma |
| D018302 | Neoplasms, Neuroepithelial |
| D017599 | Neuroectodermal Tumors |
| D009373 | Neoplasms, Germ Cell and Embryonal |
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| ID | Term |
|---|---|
| C000630586 | GDC-0084 |
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| approximately 2 years |
| Duration of response | approximately 2 years |
| Progression-free survival | approximately 2 years |
| Boston |
| Massachusetts |
| 02114 |
| United States |
| Boston | Massachusetts | 02115 | United States |
| Houston | Texas | 77030 | United States |
| Barcelona | Barcelona | 08035 | Spain |
| Derived |
| Wen PY, Cloughesy TF, Olivero AG, Morrissey KM, Wilson TR, Lu X, Mueller LU, Coimbra AF, Ellingson BM, Gerstner E, Lee EQ, Rodon J. First-in-Human Phase I Study to Evaluate the Brain-Penetrant PI3K/mTOR Inhibitor GDC-0084 in Patients with Progressive or Recurrent High-Grade Glioma. Clin Cancer Res. 2020 Apr 15;26(8):1820-1828. doi: 10.1158/1078-0432.CCR-19-2808. Epub 2020 Jan 14. |
| D009370 | Neoplasms by Histologic Type |
| D009369 | Neoplasms |
| D009375 | Neoplasms, Glandular and Epithelial |
| D009380 | Neoplasms, Nerve Tissue |