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NCT03522298 · ClinicalTrials.gov registry record · Phase 2

Safety, Pharmacokinetics and Efficacy of Paxalisib (GDC-0084) in Newly-diagnosed Glioblastoma

A Phase 2 study of Glioblastoma, Adult, sponsored by Kazia Therapeutics Limited.

Completed
Registry status
Phase 2
Development phase
30
Enrollment target
6
Study locations

NCT03522298 is a Phase 2 study of Glioblastoma, Adult that has completed, run by Kazia Therapeutics Limited. The registered enrollment target is 30 participants. The trial reports 6 study locations across 6 states.

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The verdict

NCT03522298, a Phase 2 study of Glioblastoma, Adult, has completed, sponsored by Kazia Therapeutics Limited.

COMPLETED
Registry status
Phase 2
Development phase
30 participants
Enrollment target
6
Study locations

Study Summary

This protocol has a 2-part design: This phase 2 study is an open-label, multicenter, dose-escalation and expansion study to assess the safety, tolerability, recommended phase 2 dose (RP2D), pharmacokinetics (PK) and clinical activity of paxalisib in patients with newly-diagnosed glioblastoma (GBM) with unmethylated MGMT promoter status as adjuvant therapy following surgical resection and initial chemoradiation with temozolomide (TMZ).

Conditions Studied

Interventions

  • DRUG Paxalisib (GDC-0084)

Study Locations (6)

California

  • University of California Los Angeles - Jonsson Comprehensive Cancer Center - Los Angeles

Colorado

  • University of Colorado Cancer Center - Aurora

Massachusetts

  • Dana Farber Cancer Institute - Boston

New Jersey

  • John Theurer Cancer Center at Hackensack University Medical Center - Hackensack

Oklahoma

  • University of Oklahoma Health Sciences Center (Stephenson Cancer Center) - Oklahoma City

Texas

  • MD Anderson Cancer Center - Houston

Trial Details

FieldValue
Enrollment Target 30 participants
Start Date 2018-05-15
Est. Completion 2023-03-30
Phase Phase 2

Sponsor

Kazia Therapeutics Limited

3 total trials

What the Registry Record Tells You About NCT03522298

The ClinicalTrials.gov registry entry for NCT03522298 describes a study currently listed as completed, categorized as Phase 2. The registered enrollment target is 30 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is Kazia Therapeutics Limited, which has 3 total studies on file at ClinicalTrials.gov.

The record links to 1 condition, with Glioblastoma, Adult appearing as the primary indexed condition, and to 1 intervention - of which Paxalisib (GDC-0084) is the first listed.

NCT03522298 reports 6 study locations spanning 6 distinct geographic areas - top geographies include California, Colorado, Massachusetts.

Frequently Asked Questions

What is clinical trial NCT03522298 about?

NCT03522298 is a clinical study titled "Safety, Pharmacokinetics and Efficacy of Paxalisib (GDC-0084) in Newly-diagnosed Glioblastoma". This protocol has a 2-part design: This phase 2 study is an open-label, multicenter, dose-escalation and expansion study to assess the safety, tolerability, recommended phase 2 dose (RP2D), pharmacokinetics (PK) and clinical activity of paxalisib in patients with newly-diagnosed glioblastoma (GBM) ...

What is the current status of trial NCT03522298?

This trial is currently completed. It is a Phase 2 study. The enrollment target is 30 participants. The study started on 2018-05-15. Estimated completion is 2023-03-30.

What conditions does trial NCT03522298 study?

This clinical trial studies the following conditions: Glioblastoma, Adult.

What interventions are being tested in trial NCT03522298?

The interventions under investigation include: Paxalisib (GDC-0084) (DRUG).

Who is sponsoring clinical trial NCT03522298?

This trial is sponsored by Kazia Therapeutics Limited, which has 3 total clinical trials registered on ClinicalTrials.gov.

Where is trial NCT03522298 being conducted?

This trial has 6 study locations across California, Colorado, Massachusetts, New Jersey, Oklahoma. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.

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Data sourced from official public datasets. See our methodology for details. Retrieved and formatted by PlainTrial Editorial

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