NCT04906096 · Lakshmi Nayak, MD
Paxalisib (GDC-0084) In Recurrent Or Refractory PCNSL
What this study is about
This research study is studying a drug called Paxalisib (GDC-0084) as a possible treatment for primary central nervous system lymphoma (PCNSL)
View original scientific description
This research study is studying a drug called Paxalisib (GDC-0084) as a possible treatment for primary central nervous system lymphoma (PCNSL)
Interventions
DRUG
PAXALISIB
Each study treatment cycle lasts 28 days, up to 24 months. Oral, daily, dosage per protocol
Primary outcome measures
Number of participants with Objective Response Rate (ORR)
Time frame: Up to 24 Months
The Objective Response (ORR) is defined as a complete, unconfirmed complete or partial response as determined by the investigator assessment using IPCG criteria
Who can participate
This study lists these criteria on ClinicalTrials.gov. A study coordinator reviews eligibility during screening — this page does not determine whether you qualify.
Inclusion criteria
- Participants must be able to understand and willing to sign a written informed consent document.
- Participant must have signed and dated an IRB/IEC approved written informed consent form in accordance with regulatory and institutional guidelines. This must be obtained before the performance of any protocol-related procedures that are not part of normal subject care.
- Participant must be willing and able to comply with scheduled visits, treatment schedule, laboratory tests, and other requirements of the study.
- Participants must be at least 18 years old on day of signing informed consent.
- Participants must have a Karnofsky Performance Status (KPS) ≥ 70
- Participants must have histologically confirmed R/R primary DLBCL CNS lymphoma (from brain biopsy, CSF or vitreous biopsy).
- Participants should have evidence of refractory or recurrent disease on MRI with measurable or evaluable enhancing disease.
- Participants must have recovered to ≤ grade 1 or pre-treat
Where
- Boston, Massachusetts
Collaborators
Kazia Therapeutics Limited
Related conditions & keywords
Frequently asked questions
What is a clinical trial?
A clinical trial is a research study that tests new medical treatments, drugs, devices, or procedures to determine their safety and effectiveness. Trials are carefully designed and monitored to protect participants while advancing medical knowledge.
Is it safe to participate?
Clinical trials follow strict safety guidelines and ethical standards. Trials must be reviewed and approved, and participants are closely monitored by medical professionals throughout the study. You can withdraw at any time if you choose.
Will I be compensated?
Many clinical trials offer compensation for your time, travel expenses, and inconvenience. The specific compensation varies by study and will be discussed during the screening process. All study-related medical care is typically provided at no cost to participants.
Will I receive a placebo instead of treatment?
When effective treatment exists, participants typically receive either the standard treatment plus the study intervention, or the standard treatment plus placebo. You would not be denied effective care. Placebos are primarily used when no proven treatment is available, or in addition to standard care. Your trial consent form will clearly explain what treatments you may receive.
Can I leave a trial if I change my mind?
Absolutely. Participation in clinical trials is completely voluntary. You have the right to withdraw from the study at any time, for any reason, without penalty or loss of benefits to which you are otherwise entitled.
How long does a clinical trial last?
Trial duration varies widely depending on the study design and purpose. Some trials last just a few weeks, while others may continue for months or years. The study coordinator will provide specific timeline information during your screening call.
Data: ClinicalTrials.gov · synced Jun 26, 2025 · Source of record for eligibility and locations