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COMPLETED Phase 2

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

NCT03522298 · View on ClinicalTrials.gov ↗

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

1 total trials

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Full Details on ClinicalTrials.gov ↗

What the Registry Record Tells You About NCT03522298

The ClinicalTrials.gov registry entry for NCT03522298 describes a study currently listed as completed. It is categorized as Phase 2, which is the standard way researchers label where a study sits along the investigational pathway from early safety work through later efficacy and post-marketing evaluation. 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 1 total studies on file at ClinicalTrials.gov, and sponsors are the parties responsible for study design, oversight, and regulatory filings.

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. Interventions can include drugs, devices, procedures, behavioral programs, or observational arms, and each is tracked as a separate registry field so that downstream queries can filter accurately. When a trial lists multiple interventions, it usually reflects a multi-arm design or a comparison protocol rather than a single treatment being tested in isolation. The brief summary published in the registry is the clearest source of protocol intent and should be read before drawing conclusions from any sidebar tags.

Geographic footprint matters for practical reasons: NCT03522298 reports 6 study locations spanning 6 distinct geographic areas — top geographies include California, Colorado, Massachusetts. A larger site network tends to correlate with broader recruitment capacity, but it does not imply anything about study quality, and site-level enrollment status can diverge from the overall registry status shown above. Every data point on this page comes from the public ClinicalTrials.gov dataset and is reproduced here for reference only; it is not a medical recommendation, an endorsement of the sponsor, or an invitation to enroll. Verify current status, eligibility criteria, and contact details directly at ClinicalTrials.gov, and discuss any participation decision with your own healthcare provider.

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. These conditions were identified from the trial registry and reflect the primary focus areas of the research.

What interventions are being tested in trial NCT03522298?

The interventions under investigation include: Paxalisib (GDC-0084) (DRUG). Each intervention is being evaluated for safety and efficacy as part of this clinical study.

Who is sponsoring clinical trial NCT03522298?

This trial is sponsored by Kazia Therapeutics Limited, which has 1 total clinical trials registered on ClinicalTrials.gov. The sponsor is responsible for the study's design, funding, and regulatory compliance.

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.

Related

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