Actively Recruiting
Paxalisib (GDC-0084) In Recurrent Or Refractory PCNSL
Led by Lakshmi Nayak, MD · Updated on 2025-06-26
25
Participants Needed
2
Research Sites
339 weeks
Total Duration
On this page
Sponsors
L
Lakshmi Nayak, MD
Lead Sponsor
K
Kazia Therapeutics Limited
Collaborating Sponsor
AI-Summary
What this Trial Is About
This research study is studying a drug called Paxalisib (GDC-0084) as a possible treatment for primary central nervous system lymphoma (PCNSL)
CONDITIONS
Official Title
Paxalisib (GDC-0084) In Recurrent Or Refractory PCNSL
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Able to understand and willing to sign informed consent
- Willing and able to comply with scheduled visits and study requirements
- At least 18 years old at time of consent
- Karnofsky Performance Status of 70 or higher
- Histologically confirmed recurrent or refractory primary diffuse large B-cell CNS lymphoma
- Evidence of disease on MRI with measurable or evaluable enhancing lesions
- Recovered to grade 1 or baseline from prior therapy toxic effects, except grade 2 neuropathy allowed
- Dexamethasone dose of 8 mg/day or less, stable or decreasing for 2 weeks prior to screening
- Able to undergo MRI
- Adequate blood counts and organ function as defined by study labs within 14 days before treatment
- Negative pregnancy test for women of childbearing potential within 72 hours prior to registration
- Use of effective contraception during treatment and for 28 days after last dose for women of childbearing potential and men with partner
You will not qualify if you...
- Unable to undergo MRI of the brain
- Active systemic disease
- Uncontrolled intercurrent illness
- Prior exposure to mTOR or PI3K inhibitors
- Prior malignancy requiring active treatment except specific treated cancers disease-free for 3 years
- Recent anti-cancer therapy or radiotherapy within 4 weeks or 5 half-lives prior to dosing
- Difficulty swallowing oral medications or significant gastrointestinal disease affecting absorption
- Known HIV infection, history of progressive multifocal leukoencephalopathy, or active significant infections
- Known hypersensitivity to Paxalisib or its components
- Requires treatment with strong CYP3A4 inhibitors or inducers
- Uncontrolled medical comorbidities including severe lung disease, pre-existing inflammatory bowel disease, or baseline grade 2 or higher diarrhea
- Uncontrolled type I diabetes, uncontrolled type II diabetes despite oral medication, or HbA1c above 9% with high fasting glucose
- Uncontrolled hypertension despite optimal management
- Positive hepatitis B surface antigen or hepatitis B DNA PCR positive; positive hepatitis C PCR
- Pregnant or breastfeeding
- Concurrent participation in another therapeutic clinical trial
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Trial Site Locations
Total: 2 locations
1
Brigham and Women's Hospital
Boston, Massachusetts, United States, 02115
Not Yet Recruiting
2
Dana Farber Cancer Institute
Boston, Massachusetts, United States, 02115
Actively Recruiting
Research Team
L
Lakshmi Nayak, MD
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
NA
Model
SINGLE_GROUP
Primary Purpose
TREATMENT
Number of Arms
1
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