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Paxalisib + Metformin + Ketogenic Diet for Glioblastoma
Study Summary
This trial is for patients with newly diagnosed or recurring glioblastoma. Subjects will take Paxalisib and Metformin every day while also following a ketogenic diet.
Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowTimeline
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Side effects data
From 2015 Phase 4 trial • 156 Patients • NCT02002221Trial Design
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- I am not currently receiving, nor expected to need, cancer treatment in the next year for another cancer.Your doctor believes that you will live for at least 12 more weeks.My cancer has an unmethylated MGMT status, or I can't take temozolomide due to its methylated status.I have undergone radiation therapy before.I am allergic or react badly to paxalisib or metformin.I am not currently on any standard or experimental brain tumor treatments.My organs and bone marrow are working well.I've had successful surgery for my condition and recovered well.I have been diagnosed with a specific type of brain tumor called glioblastoma, and it is not located in the lower back part of my brain.I have a family history of high triglycerides.I don't have any health conditions that could make the study drug risky for me.I completed most of my radiation treatment as planned, starting it soon after surgery and finishing 5 weeks before joining this study.I have had severe pancreatitis or lack of pancreatic enzyme production.I have a new diagnosis of glioblastoma without MGMT methylation.My cancer has not worsened after radiation treatment.I recently had surgery to remove a returning or worsening tumor and meet all required conditions.You have read and signed a document that explains the study and its risks, and it has been approved by the organization overseeing the study.You are unable to have an MRI scan.My cancer has worsened on scans 3 months after finishing chemoradiotherapy.My cancer is a type of brain tumor called glioblastoma, not located in the lower back part of my brain.I have had previous radiation and may need to wait for treatment based on MRI results.I am taking less than 4mg of dexamethasone daily.My cancer has grown despite receiving chemoradiation.You have been on a keto diet for more than 2 weeks while dealing with your illness.I have had weight loss surgery in the past.I am 18 years old or older.I am mostly able to care for myself.I have had severe kidney stones that needed treatment by a specialist.I have received radiation therapy for brain cancer following official guidelines.My cancer's MGMT status can be any type.My tumor has a mutation in the IDH-1 or IDH-2 gene.I have been treated with bevacizumab or drugs targeting the PI3K pathway.I am not taking any strong medication that affects drug metabolism.
- Group 1: Arm 1: Newly diagnosed MGMT unmethylated glioblastoma
- Group 2: Arm 2: Recurrent glioblastoma, regardless of methylation status
- No Placebo-Only Group - All patients enrolled in this study will receive some form of active treatment.
- 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
Is it possible to sign up for the clinical trial at this time?
"From what is indicated on clinicaltrials.gov, this trial is still in need of patients and is currently recruiting them. The first posting for the trial was on 2/14/2022, with the most recent edit taking place on 10/3/2022."
What is the sample size of this clinical trial?
"The answer is affirmative. The online clinicaltrials.gov registry has the latest information on this study's status and recruitment goals. 33 individuals are needed for the trial which is taking place at a single medical facility."
Have there been any governmental approvals of Paxalisib?
"Given that this is a Phase 2 trial, which means there is some data supporting safety but no efficacy data, our team at Power has assessed the safety of Paxalisib to be a 2."
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