Study of GDC-0084 in Pediatric Patients With Newly Diagnosed Diffuse Intrinsic Pontine Glioma or Diffuse Midline Gliomas - Trial NCT03696355
Access comprehensive clinical trial information for NCT03696355 through Pure Global AI's free database. This Phase 1 trial is sponsored by St. Jude Children's Research Hospital and is currently Not yet recruiting. The study focuses on Brain and Central Nervous System Tumors. Target enrollment is 27 participants.
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Study Focus
Sponsor & Location
St. Jude Children's Research Hospital
Timeline & Enrollment
Phase 1
Nov 19, 2018
Jun 01, 2024
Primary Outcome
Estimate the maximum tolerated dose (MTD)/recommended phase 2 dose (RP2D) of GDC-0084 after standard-of-care radiation therapy (RT),Incidence of adverse events at least possibly associated with GDC-0084 after RT by stratum,Pharmacokinetics of GDC-0084 by stratum
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
ICD-10 Classifications
Data Source
ClinicalTrials.gov
NCT03696355
Non-Device Trial