BridgeMD
New treatment option for Primary Central Nervous System Lymphoma
Official title Paxalisib (GDC-0084) In Recurrent Or Refractory PCNSL
ClinicalTrials.gov ID: NCT04906096
What this study is testing
What is PAXALISIB?
PAXALISIB is an investigational medicine, given as an once-daily pill taken by mouth, being studied as a potential treatment for primary central nervous system lymphoma.
Also referred to as GDC-0084.
Plain-language explanation of the investigational treatment - it is being studied and is not an approved or proven therapy. The study team can confirm the details.
- What it's testing
- This research study is studying a drug called Paxalisib (GDC-0084) as a possible treatment for primary central nervous system lymphoma (PCNSL)
- Phase 2: a mid-size study of how well it works
- Time commitment: about 24 months
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 18 and older
You may be able to join if
- 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...
- 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
You likely can't join if
- Participants unable to undergo MRI brain.
- Participants with active systemic disease.
- Participants with uncontrolled intercurrent illness.
- Participants with prior exposure to mTOR/PI3K inhibitors
- Prior malignancy (or any other malignancy requiring active treatment), except for adequately treated basal cell or squamous cell skin cancer, in situ...
- Participants who have received prior systemic anti-cancer therapy including investigational agents or radiotherapy within 4 weeks OR 5 half-lives...
See the full eligibility criteria
Who can join
- 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...
- 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-treatment baseline from clinically significant toxic effects of prior therapy; exception, participants with ≤ grade 2 neuropathy may be eligible.
- Participant with dexamethasone requirement of ≤ 8mg/day or bioequivalent with corticosteroid usage at a stable or decreasing dose 2 weeks prior to screening.
- Participants must be able to undergo MRI.
- Participants must demonstrate adequate as defined below (all screening labs should be performed within 14 days of treatment initiation):
- Hematology
- White Blood Count (WBC) ≥ 2 K/µL
- Platelet count ≥ 100 K/µL
- Absolute Neutrophil Count ≥ 1.5 K/µL
- Hemoglobin \> 9.0 g/dL or ≥ 5.6 mmol/L (Criteria must be met without erythropoietin dependency and without packed red blood cell (pRBC) transfusion within last 2 weeks)
- Biochemistry
- Serum creatinine ≤1.5 x institutional ULN OR Measured or calculated creatinine clearance ≥30 mL/min for participant with creatinine levels \>1.5 × institutional ULN (Creatinine clearance should be calculated per...
- Aspartate aminotransferase (AST) and alanine aminotransferase (ALT) ≤ 2.5 x ULN (≤5 × ULN for participants with liver metastases)
- Total bilirubin (TBILI) ≤ 1.5 x institutional ULN (except people with Gilbert Syndrome who must have a total bilirubin level of \ 1.5 × ULN)
- Women of childbearing potential (WOCBP) must have a negative serum pregnancy within 72 hours prior to registration.
- WOCBP who are sexually active must use highly effective methods of contraception during treatment and for 28 days after the last dose of paxalisib. For male people with a pregnant or non-pregnant WOCBP partner...
- Established use of oral, injected, or implanted hormonal methods of contraception
- Correctly placed intrauterine device (IUD) or intrauterine system (IUS)
- Male condom or female condom used WITH a spermicide (i.e., foam, gel, film, cream)
- Male sterilization with appropriately confirmed absence of sperm in the post-vasectomy ejaculate
- Bilateral tubal ligation or bilateral salpingectomy
What rules you out
- Participants unable to undergo MRI brain.
- Participants with active systemic disease.
- Participants with uncontrolled intercurrent illness.
- Participants with prior exposure to mTOR/PI3K inhibitors
- Prior malignancy (or any other malignancy requiring active treatment), except for adequately treated basal cell or squamous cell skin cancer, in situ cervical cancer, superficial bladder cancer or other cancer from...
- Participants who have received prior systemic anti-cancer therapy including investigational agents or radiotherapy within 4 weeks OR 5 half-lives prior to dosing, whichever is shorter. Note: Participants must have...
- Participants who have difficulty with or are unable to swallow oral medication or have significant gastrointestinal disease that would limit absorption of oral medication.
- Known history of infection with HIV, prior history of PML or any active significant infection (eg, bacterial, viral, or fungal).
- Known history of hypersensitivity or anaphylaxis to paxalisib including active product or excipient components.
- Requires treatment with a strong cytochrome P450 3A4 (CYP3A4) inhibitor/inducer which may have an effect of the metabolism of paxalisib.
- Participants with uncontrolled medical comorbidities per investigator discretion including but not limited to interstitial lung disease, severe dyspnea at rest or requiring oxygen therapy, pre-exisiting Crohn's disease...
- Participants with type I diabetes mellitus, participants with uncontrolled type II diabetes mellitus,despite being on oral anti-diabetic medication. , participants with Type II diabetes mellitus that are well controlled...
- Participants with uncontrolled hypertension despite optimal medical management (per investigator's assessment).
- Hepatitis B or C serologic status: people who are hepatitis B core antibody (anti-HBc) positive and who are hepatitis B surface antigen (HBsAg) negative will need to have a negative polymerase chain reaction (PCR) and...
- Breast feeding or pregnant
- Concurrent participation in another therapeutic trial.
The study team makes the final eligibility decision.
Where it's taking place
- Boston, Massachusetts, United States
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The study runs about 24 months per participant, based on its public description. The team confirms the exact schedule and number of visits before you enroll.
Who can join this trial?
This study is enrolling all sexes, 18 years and older. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Boston, Massachusetts, United States. Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.