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NCT03696355 · ClinicalTrials.gov registry record · Phase 1
Study of GDC-0084 in Pediatric Patients With Newly Diagnosed Diffuse Intrinsic Pontine Glioma or Diffuse Midline Gliomas
A Phase 1 study, sponsored by St. Jude Children's Research Hospital.
- Completed
- Registry status
- Phase 1
- Development phase
- 27
- Enrollment target
NCT03696355 is a Phase 1 study that has completed, run by St. Jude Children's Research Hospital. The registered enrollment target is 27 participants.
The verdict
NCT03696355, a Phase 1 study, has completed, sponsored by St. Jude Children's Research Hospital.
- COMPLETED
- Registry status
- Phase 1
- Development phase
- 27 participants
- Enrollment target
Study Summary
Pediatric high-grade gliomas are highly aggressive and treatment options are limited. The purpose of this first-in-pediatrics study is to examine the safety, tolerability, and pharmacokinetics of GDC-0084 and to estimate its maximum tolerated dose (MTD) when administered to pediatric patients with diffuse intrinsic pontine glioma (DIPG) or other diffuse midline H3 K27M-mutant gliomas after they have received radiation therapy (RT). GDC-0084 is a brain-penetrant inhibitor of a growth-promoting cell signaling pathway that is dysregulated in the majority of diffuse midline glioma tumor cells. This study is also designed to enable a preliminary assessment of the antitumor activity of single-agent GDC-0084, in the hope of enabling rational combination therapy with systemic therapy and/or radiation therapy (RT) in this patient population, which is in desperate need of therapeutic advances. Primary Objectives 1. To estimate the maximum tolerated dose (MTD) and/or the recommended phase 2 dosage (RP2D) of GDC-0084 in pediatric patients with newly diagnosed diffuse midline glioma, including diffuse intrinsic pontine glioma (DIPG) 2. To define and describe the toxicities associated with administering GDC-0084 after radiation therapy (RT) in a pediatric population 3. To characterize the pharmacokinetics of GDC-0084 in a pediatric population Secondary Objectives 1. To estimate the rate and duration of radiographic response in patients with newly diagnosed DIPG or other diffuse midline glioma treated with RT followed by GDC-0084 2. To estimate the progression-free survival (PFS) and overall survival (OS) distributions for patients with newly diagnosed DIPG or other diffuse midline glioma treated with RT followed by GDC-0084
Interventions
- RADIATION radiation therapy
- DRUG GDC-0084
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 27 participants |
| Start Date | 2018-11-19 |
| Est. Completion | 2022-09-04 |
| Phase | Phase 1 |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT03696355
The ClinicalTrials.gov registry entry for NCT03696355 describes a study currently listed as completed, categorized as Phase 1. The registered enrollment target is 27 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is St. Jude Children's Research Hospital, which has 410 total studies on file at ClinicalTrials.gov.
The record links to 0 conditions, and to 2 interventions - of which radiation therapy is the first listed.
NCT03696355 reports 0 study locations.
Frequently Asked Questions
What is clinical trial NCT03696355 about?
NCT03696355 is a clinical study titled "Study of GDC-0084 in Pediatric Patients With Newly Diagnosed Diffuse Intrinsic Pontine Glioma or Diffuse Midline Gliomas". Pediatric high-grade gliomas are highly aggressive and treatment options are limited. The purpose of this first-in-pediatrics study is to examine the safety, tolerability, and pharmacokinetics of GDC-0084 and to estimate its maximum tolerated dose (MTD) when administered to pediatric patients with d...
What is the current status of trial NCT03696355?
This trial is currently completed. It is a Phase 1 study. The enrollment target is 27 participants. The study started on 2018-11-19. Estimated completion is 2022-09-04.
What interventions are being tested in trial NCT03696355?
The interventions under investigation include: radiation therapy (RADIATION), GDC-0084 (DRUG).
Who is sponsoring clinical trial NCT03696355?
This trial is sponsored by St. Jude Children's Research Hospital, which has 410 total clinical trials registered on ClinicalTrials.gov.
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