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Inhibitor

GDC-0084 for Brain Tumor

Phase 1
Waitlist Available
Led By Christopher Tinkle, MD, PhD
Research Sponsored by St. Jude Children's Research Hospital
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Be younger than 65 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 1 month after start of gdc-0084 treatment
Awards & highlights

Study Summary

This trial is studying a brain-penetrant inhibitor of a growth-promoting cell signaling pathway to treat pediatric patients with diffuse intrinsic pontine glioma or other diffuse midline H3 K27M-mutant gliomas.

Eligible Conditions
  • Brain Tumor

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~1 month after start of gdc-0084 treatment
This trial's timeline: 3 weeks for screening, Varies for treatment, and 1 month after start of gdc-0084 treatment for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
Therapeutic radiology procedure
Incidence of adverse events at least possibly associated with GDC-0084 after RT by stratum
Pharmacokinetics of GDC-0084 by stratum
Secondary outcome measures
Duration of best overall response by stratum
Overall survival for patients treated with GDC-0084 after RT
Progression-free survival for patients treated with GDC-0084 after RT
+1 more

Trial Design

2Treatment groups
Experimental Treatment
Group I: Stratum A2Experimental Treatment2 Interventions
Four to 12 weeks after the completion of standard RT, subjects will received the MTD dose established in the Stratum A1 dose escalation phase. Subjects who are unable to swallow capsules will initially be enrolled until the Stratum A1 expansion cohort is filled. Once the Stratum A1 expansion cohort has been filled, both subjects who are able to swallow capsules and those unable to swallow capsules may be enrolled. Subjects who are unable to swallow capsules will take GDC-0084 as an open capsule sprinkled in purée such as applesauce. Subjects who have completed the first course of therapy and are able to swallow capsules may take GDC-0084 as capsules. Treatment may be continued for up to 24 months (26 cycles) in the absence of disease progression or unacceptable toxicity.
Group II: Stratum A1Experimental Treatment2 Interventions
Dose Escalation Phase: Four to 12 weeks after the completion of standard RT, subjects who are able to swallow capsules will receive single-agent oral GDC-0084 at one of the 4 dose levels once daily in cycles of 28 days. During cycle 1 only, a single dose of GDC-0084 will be withheld on day 2, for a total of 27 doses. Treatment may be continued for up to 24 months (26 cycles) in the absence of disease progression or unacceptable toxicity. Dose Expansion Phase Four to 12 weeks after the completion of standard RT, subjects who are able to swallow capsules will receive the MTD dose established in the Stratum A dose escalation phase. Subjects who completed the first course of therapy may take GDC-0084 as an open capsule sprinkled in purée such as applesauce. Treatment may be continued for up to 24 months (26 cycles) in the absence of disease progression or unacceptable toxicity.
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
GDC-0084
2018
Completed Phase 1
~60
radiation therapy
1994
Completed Phase 3
~13390

Find a Location

Who is running the clinical trial?

St. Jude Children's Research HospitalLead Sponsor
428 Previous Clinical Trials
5,306,586 Total Patients Enrolled
Kazia Therapeutics LimitedIndustry Sponsor
11 Previous Clinical Trials
1,563 Total Patients Enrolled
Christopher Tinkle, MD, PhDPrincipal InvestigatorSt. Jude Children's Research Hospital

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

Has this research ever been conducted before?

"Exploration into radiation therapy commenced in 2018 with Kazia Therapeutics Limited leading the charge. Following a successful Phase 1 trial, which had 27 participants, 6 live studies are now conducted across 7 nations and 52 cities."

Answered by AI

What primary aims are being sought with this medical experiment?

"According to the clinical trial sponsor Kazia Therapeutics Limited, this study is measuring a primary outcome over one month post-treatment with GDC-0084. Additionally, secondary outcomes are being tracked such as Rate of Best Overall Response by Stratum (CR/PR/SD), Overall Survival for Patients Treated With GDC-0084 after RT and Duration of Best Overall response By Stratum (from first measurement criteria met until PD)."

Answered by AI

Is this trial available for minors to participate in?

"According to the criteria for participation in this trial, those eligible must be between 2 and 21 years of age."

Answered by AI

Are there still openings for individuals to join the research project?

"From the clinicaltrials.gov portal, it is evident that this trial has not been recruiting participants since August 24th 2022 and thus applications are presently declined. However, 449 other studies currently have open enrollment requirements."

Answered by AI

Are there other precedents of radiation therapy trials?

"Currently, 6 trials related to radiation therapy are ongoing. One of these is in the crucial third phase. Though a significant portion of research has been conducted in Boston, Massachusetts; 78 sites across America are participating in clinical studies for this treatment option."

Answered by AI

Has the FDA rendered a verdict on radiation therapy?

"There is limited research to support the safety of radiation therapy, so it was scored a 1 on our team's scale."

Answered by AI

What is the maximum capacity of participants accepted into this medical experiment?

"Unfortunately, this medical research project is no longer actively seeking patient participants. The trial was initially listed on November 19th 2018 and last updated on August 24th 2022. There are presently 443 clinical trials enrolling patients with diffuse intrinsic pontine glioma as well as 6 radiation therapy studies recruiting individuals for participation."

Answered by AI

Do I meet the criteria to join this research program?

"Eligibility for this medical trial requires participants to have diffuse intrinsic pontine glioma and be within the ages of 2-21. Currently, 27 patients need to be enrolled in order for the study to reach its desired enrollment."

Answered by AI
Recent research and studies
clinicaltrials.govStudy
Study of GDC-0084 in Pediatric Patients With Newly Diagnosed Diffuse Intrinsic Pontine Glioma or Diffuse Midline Gliomas
2018. "Study of GDC-0084 in Pediatric Patients With Newly Diagnosed Diffuse Intrinsic Pontine Glioma or Diffuse Midline Gliomas". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT03696355.
~4 spots leftby Apr 2025
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