Your session is about to expire
← Back to Search
PARP Inhibitor
PARP Inhibitor + Temozolomide for Brain Cancer (PNOC017 Trial)
Phase 1
Recruiting
Led By Sabine Mueller
Research Sponsored by University of California, San Francisco
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
Subjects in Arm B must have been treated with maximal safe resection of tumor.
Monoclonal antibody treatment: at least three half-lives must have elapsed prior to registration, and subjects on bevacizumab must have received their last dose >= 32 days prior to study registration.
Timeline
Screening 3 weeks
Treatment Varies
Follow Up up to 5 years
Awards & highlights
PNOC017 Trial Summary
This trial is testing the side effects and best dose of two drugs, BGB-290 and temozolomide, in treating adolescents and young adults with IDH1/2-mutant grade I-IV glioma.
Who is the study for?
Adolescents and young adults with newly diagnosed or recurrent IDH1/2-mutant grade I-IV glioma. Participants must have stable neurological deficits, not be on certain medications, have specific blood counts and organ functions within normal ranges, be able to swallow capsules, agree to use contraception if of childbearing potential, and provide tissue samples for study. Exclusions include prior treatment with IDH inhibitors, active infections or other cancers, bleeding disorders within the last 6 months, unresolved effects from previous therapies that pose a safety risk.Check my eligibility
What is being tested?
The trial is testing the combination of BGB-290 (a PARP inhibitor) and Temozolomide (a chemotherapy drug) in treating brain tumors with specific genetic mutations. The goal is to determine the safest doses while assessing how well these drugs work together to inhibit tumor growth by blocking enzymes needed for cell growth and killing or stopping cancer cells from dividing.See study design
What are the potential side effects?
Potential side effects may include typical reactions associated with chemotherapy such as nausea, fatigue, hair loss; as well as those related to BGB-290 like anemia or low white blood cell counts which can increase infection risk. There might also be liver function changes due to medication interactions.
PNOC017 Trial Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowSelect...
I have had surgery to remove as much of my tumor as safely possible.
Select...
It has been long enough since my last monoclonal antibody treatment to join this study.
Select...
My kidney function, measured by creatinine levels, is within the normal range.
Select...
I had my last dose of strong chemotherapy 3 weeks ago, or 6 weeks ago if it was a specific type (nitrosourea).
Select...
My cancer has a specific genetic change in IDH1 or IDH2.
Select...
I am over 16 and can do most activities, or I am 16 or under and can do most activities for my age.
Select...
My platelet count is at least 100,000/mm^3 without transfusions for 7 days.
Select...
I can swallow capsules.
PNOC017 Trial Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ up to 5 years
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~up to 5 years
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
Proportion of participants with Dose Limiting Toxicities (DLTs)
Other outcome measures
Overall survival (OS)
Progression free survival (PFS)
PNOC017 Trial Design
2Treatment groups
Experimental Treatment
Group I: Arm B (BGB-290, temozolomide)Experimental Treatment2 Interventions
Patients with grades I-IV recurrent IDH1/2 mutant glioma receive 60mg PARP inhibitor BGB-290 PO BID on days 1-28 and 20mg temozolomide PO daily on days 1-21. Courses repeat every 28 days for up to 24 months in the absence of disease progression or unacceptable toxicity.
Cohort B0: Patients who are surgical candidates with grades I-IV recurrent IDH1/2 mutant glioma receive 60mg PARP inhibitor BGB-290 PO BID for 7 days, pre-surgery. After recovery from surgery, patients receive PARP inhibitor BGB-290 PO BID on days 1-28 and 20mg temozolomide PO daily on days 1-21. Courses repeat every 28 days for up to 24 months in the absence of disease progression or unacceptable toxicity.
Group II: Arm A (BGB-290, temozolomide)Experimental Treatment2 Interventions
Patients with grades III-IV newly diagnosed IDH1/2 mutant glioma receive 60mg PARP inhibitor BGB-290 PO BID on days 1-28 and 20mg temozolomide PO daily on days 1-21. Courses repeat every 28 days for up to 24 months in the absence of disease progression or unacceptable toxicity.
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
PARP Inhibitor BGB-290
2020
Completed Phase 2
~60
Temozolomide
2010
Completed Phase 3
~1930
Find a Location
Who is running the clinical trial?
University of California, San FranciscoLead Sponsor
2,505 Previous Clinical Trials
15,237,477 Total Patients Enrolled
Pacific Pediatric Neuro-Oncology ConsortiumOTHER
14 Previous Clinical Trials
659 Total Patients Enrolled
BeiGene USA, Inc.Industry Sponsor
2 Previous Clinical Trials
346 Total Patients Enrolled
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- I can attend all required follow-up visits and tests.I do not have diffuse intrinsic pontine glioma.I am taking low-dose aspirin or NSAIDs.My lower grade glioma has worsened after surgery but I've had other treatments.I have had surgery to remove as much of my tumor as safely possible.It has been long enough since my last monoclonal antibody treatment to join this study.I have a high-grade, newly diagnosed IDH-mutant brain tumor.I am not on antibiotics for an infection when starting therapy.My neurological symptoms have been stable for at least a week.My seizures are well controlled with specific medication.I had my last dose of strong chemotherapy 3 weeks ago, or 6 weeks ago if it was a specific type (nitrosourea).My cancer has spread to the lining of my brain and spinal cord.I had surgery to remove as much of my tumor as possible, followed by radiation. I may or may not have taken TMZ during radiation.I have previously been treated with a PARP inhibitor.I have not been treated with IDH1 or IDH2 inhibitors or any investigational drugs.I have been diagnosed with another type of cancer.My cancer has a specific genetic change in IDH1 or IDH2.I haven't had radiation therapy in the last 4 weeks.I have recovered from side effects of my previous cancer treatments.I have recovered from side effects of biological treatments and it's been over a week since my last dose.I am using medication to prevent blood clots in my catheter.My kidney function, measured by creatinine levels, is within the normal range.I will discuss my last biologic treatment with the study chair due to its long-lasting effects.I will start TMZ and BGB-290 treatment after finishing radiation and meeting all other requirements.I have a recurring brain tumor with IDH1/2 mutation and MRI-confirmed progression.My cancer is in the spine or brain but hasn't spread widely in the brain's lining.I had surgery and radiation for my high-grade glioma before it came back.I am over 16 and can do most activities, or I am 16 or under and can do most activities for my age.I haven't used certain strong medications or foods that affect liver enzymes recently.I don't have serious side effects from past treatments, except those considered safe.I am not HIV-positive or on antiretroviral therapy.I am using low-molecular weight heparin.I am willing to use birth control during and 4 months after the study.My platelet count is at least 100,000/mm^3 without transfusions for 7 days.I haven't had significant bleeding or coughed up blood in the last 6 months.I have been on a stable or decreasing dose of dexamethasone for at least a week.I do not have any serious illnesses that would stop me from following the study's requirements.I am currently taking blood thinners like heparin or warfarin.I can swallow capsules.
Research Study Groups:
This trial has the following groups:- Group 1: Arm A (BGB-290, temozolomide)
- Group 2: Arm B (BGB-290, temozolomide)
Awards:
This trial has 1 awards, including:- No Placebo-Only Group - All patients enrolled in this study will receive some form of active treatment.
Timeline:
This trial has the following timeline:- Screening: It may take up to 3 Weeks to process to see if you qualify in this trial.
- Treatment: The duration you will receive the treatment varies.
- Follow Ups: You may be asked to continue sharing information regarding the trial for 6 Months after you stop receiving the treatment.
Frequently Asked Questions
These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.
Is enrollment open for this research project?
"As depicted on clinicaltrials.gov, recruitment is still open for this trial which was posted in April 2019 and last updated in July 2022."
Answered by AI
Is this clinical trial a pioneering effort?
"Since 2002, PARP Inhibitor BGB-290 has been studied extensively. The first trial was conducted by Schering-Plough and involved 60 participants; this led to the drug's Phase 2 approval status. Currently, 211 separate trials are in progress across 986 cities and 40 countries worldwide."
Answered by AI
What criteria should participants meet to be eligible for this research?
"The inclusion criteria for this research trial necessitates that candidates have a diagnosis of glioblastoma and be within the age range of 13 to 39. In total, 78 patients will be accepted into the study."
Answered by AI
Is the age requirement for enrolling in this trial restricted to individuals under sixty?
"According to the requirements for this research trial, hopefuls must be between 13 and 39 years of age."
Answered by AI
What is the primary purpose of administering BGB-290 as a PARP Inhibitor?
"BGB-290, a PARP Inhibitor commonly administered to alleviate the effects of nitrosourea treatment, is also employed in refractory cases such as advanced directives, refractory neuroblastoma, and mycosis fungoides."
Answered by AI
To what extent is the study participant pool expanding?
"To recruit the necessary 78 participants, this clinical trial requires enrollees to meet a certain set of criteria. Potential patients may join from two locations; Texas Children's Hospital in Houston, or Children's Hospital of Philadelphia."
Answered by AI
Has the Food and Drug Administration given authorization to employ BGB-290 as a PARP Inhibitor?
"The safety of PARP Inhibitor BGB-290 is assessed to be a 1 based on the Phase 1 trial which suggests that there is minimal evidence in favour of its efficacy and security."
Answered by AI
In how many healthcare facilities is this clinical trial being conducted?
"This clinical trial is available at 20 different sites throughout the United States, including Texas Children's Hospital in Houston, The Children's Hospital of Philadelphia in Pennsylvania, and Huntsman Cancer Institute/University of Utah in Salt Lake City."
Answered by AI
Can you provide a synopsis of the other experiments that have been done with PARP Inhibitor BGB-290?
"As of now, 211 research studies are being conducted on PARP Inhibitor BGB-290. 24 of those trials have advanced to Phase 3 and the majority are hosted in Seoul, Songpa; however, there are 4,921 clinical trial sites involved with testing this medication globally."
Answered by AI
Other Trials to Consider
Popular Categories
Share this study with friends
Copy Link
Messenger