Clinical trial · Interventional
A Study of GDC-0084 in Patients With Progressive or Recurrent High-Grade Glioma
An Open-label, Phase I, Dose-escalation Study Evaluating the Safety and Tolerability of GDC-0084 Administered to Patients With Progressive or Recurrent High-grade Glioma
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
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.
Conditions
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Glioblastoma, Glioma | Glioblastoma | CURATED_BROADER | 0.80 |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| GDC-0084 | Drug | — | UNRESOLVED |
Design
Arms and outcomes
Arms (1)
- type
- EXPERIMENTAL
- label
- Single Arm
- interventionNames
- Drug: GDC-0084
Primary outcomes (2)
- measure
- Safety: Incidence of adverse events
- timeFrame
- approximately 2 years
- measure
- Maximum tolerated dose (MTD)
- timeFrame
- approximately 1 year
Secondary outcomes (4)
- measure
- Pharmacokinetics: Area under the concentration-time curve
- timeFrame
- 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
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
Inclusion Criteria: * Adult patients, \>/= 18 years of age * Interval of at least 12 weeks from completion of adjuvant radiotherapy for gliomas to study entry * Karnofsky Performance Status of \>/= 70 at screening * Confirmed measurable disease per RANO * Adequate hematologic and organ function Patients enrolled in Stage 1: * Histologically documented recurrent or progressive high-grade gliomas (WHO Grade III-IV) * Prior treatment with at least one regimen for gliomas (radiotherapy with or without chemotherapy for Grade III gliomas and radiotherapy with chemotherapy for Grade IV gliomas) and/or not considered to be a candidate for regimens known to provide clinical benefit Patients enrolled in Stage 2: * Histologically documented recurrent or progressive glioblastoma (WHO Grade IV gliomas) * Prior treatment with one or two regimens for glioblastoma (with the initial regimen consisting of radiotherapy with chemotherapy) Exclusion Criteria: * Treatment with anti-tumor therapy (approved or experimental) within 4 weeks prior to initiation of study drug * Requirement for anticoagulants such as warfarin or any other warfarin-derivative anticoagulants; low-molecular-weight heparin is permitted * Any contraindication to MRI examination * Evidence of Grade \>/= 1 intracranial hemorrhage * Active congestive heart failure or ventricular arrhythmia requiring medication * Clinically significant history of liver disease, including viral or other hepatitis, current alcohol abuse or cirrhosis * Unresolved toxicity from prior therapy with the exception of lymphopenia (for patients with prior temozolomide) and alopecia * Pregnant or lactating women
References
Publications (2)
- DERIVEDEllingson 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. PMID 32269051
- DERIVEDWen 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. PMID 31937616