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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: Completed Phase 2 study of Glioblastoma, Adult, sponsored by Kazia Therapeutics Limited.
NCT03522298 is a Phase 2 study of Glioblastoma, Adult that has completed, run by Kazia Therapeutics Limited. The registered enrollment target is 30 participants, below the 133-participant average among 30,622 other Phase 2 trials with a reported enrollment target (77% lower). The trial reports 6 study locations across 6 states. According to ClinicalTrials.gov, the official US trial registry.
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).
Primary Outcome
A DLT was defined as a Grade 3 or 4 toxicity occurring within the DLT assessment window and assessed to be probably or possibly related to paxalisib. DLTs were graded using the Common Terminology Criteria for Adverse Events (CTCAE), version 4.03. CTCAE Grade 3 is a severe adverse event (AE) and Grade 4 is a life-threatening or disabling AE. DLTs were collected to determine the maximum tolerated dose (MTD), which was defined as the dose level below the dose at which less than 33% of participants
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
| Field | Value |
|---|---|
| Enrollment Target | 30 participants |
| Start Date | 2018-05-15 |
| Est. Completion | 2023-03-30 |
| Phase | Phase 2 |
What the finished NCT03522298 record still lists
NCT03522298 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 30 participants, a relatively small participant target, below the 133-participant average among 30,622 other Phase 2 trials with a reported enrollment target (77% lower).
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 lists 6 locations in 6 states (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.
Learn More About Clinical Trials
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Where NCT03522298's enrollment target sits among peer trials
30 1582nd of 2000 higher than 332 of 2,000 other Phase 2 trials
participants (enrollment target), bucketed by value
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