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Anti-diabetic drug

Paxalisib + Metformin + Ketogenic Diet for Glioblastoma

Phase 2

Recruiting

Led By Howard Fine, MD

Research Sponsored by Weill Medical College of Cornell University

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Patient must have had previous radiation.

Optimal surgical resection performed, with satisfactory clinical recovery in the judgment of the investigator (patients for who whom "optimal" surgical resection is considered only a subtotal resection or a biopsy, will be considered eligible).

Timeline

Screening 3 weeks

Treatment Varies

Follow Up from the start of study enrollment until death, up to approximately 18 months

Awards & highlights

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.

Who is the study for?

This trial is for adults with newly diagnosed or recurring glioblastoma, specifically those who have had radiation and show no tumor progression post-radiation. Participants must not be allergic to metformin, should have a life expectancy over 12 weeks, and agree to use contraception. Exclusions include other anti-glioma treatments, certain surgeries or conditions like severe diabetes (A1C > 7.5%), specific genetic mutations (IDH-1, IDH-2), or being on a ketogenic diet for more than two weeks prior.Check my eligibility

What is being tested?

The study tests the safety and effects of Paxalisib taken daily alongside Metformin while maintaining a high fat, low carbohydrate ketogenic diet in patients with glioblastoma. It aims to understand how this combination affects the cancer's behavior.See study design

What are the potential side effects?

Potential side effects may include typical reactions to medication such as digestive issues due to metformin; however, specifics about Paxalisib's side effects are not provided but could align with common drug reactions like fatigue or nausea.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

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I have undergone radiation therapy before.

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I've had successful surgery for my condition and recovered well.

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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.

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My cancer has an unmethylated MGMT status, or I can't take temozolomide due to its methylated status.

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I completed most of my radiation treatment as planned, starting it soon after surgery and finishing 5 weeks before joining this study.

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I have a new diagnosis of glioblastoma without MGMT methylation.

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My cancer has not worsened after radiation treatment.

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My cancer is a type of brain tumor called glioblastoma, not located in the lower back part of my brain.

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I have had previous radiation and may need to wait for treatment based on MRI results.

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I am taking less than 4mg of dexamethasone daily.

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I am 18 years old or older.

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I am mostly able to care for myself.

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I have received radiation therapy for brain cancer following official guidelines.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ from the start of study enrollment until death, up to approximately 18 months

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~from the start of study enrollment until death, up to approximately 18 months

This trial's timeline: 3 weeks for screening, Varies for treatment, and from the start of study enrollment until death, up to approximately 18 months for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.

Primary outcome measures

Progression-free survival, defined as the survival rate at 6 months

Secondary outcome measures

Change in insulin levels

Change in tumor glucose uptake values

Overall survival, defined as the time of first study treatment to death from any cause

Side effects data

From 2015 Phase 4 trial • 156 Patients • NCT02002221

13%

Nasopharyngitis

10%

Hyperhidrosis

Hunger

Tremor

Asthenia

Hypoglycaemia

Femoral neck fracture

Squamous cell carcinoma of the tongue

100%

80%

60%

40%

20%

Study treatment Arm

Vildagliptin (LAF237)

Placebo

Trial Design

2Treatment groups

Experimental Treatment

Group I: Arm 2: Recurrent glioblastoma, regardless of methylation statusExperimental Treatment3 Interventions

Group II: Arm 1: Newly diagnosed MGMT unmethylated glioblastomaExperimental Treatment3 Interventions

Treatment

First Studied

Drug Approval Stage

How many patients have taken this drug

Metformin

2006

Completed Phase 4

~2430

0 / 13Eligibility criteria met

Find a Location

Who is running the clinical trial?

Weill Medical College of Cornell UniversityLead Sponsor

1,054 Previous Clinical Trials

1,316,495 Total Patients Enrolled

8 Trials studying Glioblastoma

467 Patients Enrolled for Glioblastoma

Kazia Therapeutics LimitedIndustry Sponsor

11 Previous Clinical Trials

1,557 Total Patients Enrolled

2 Trials studying Glioblastoma

1,060 Patients Enrolled for Glioblastoma

Howard Fine, MDPrincipal InvestigatorWeill Medical College of Cornell University

6 Previous Clinical Trials

565 Total Patients Enrolled

3 Trials studying Glioblastoma

121 Patients Enrolled for Glioblastoma

Media Library

Metformin (Anti-diabetic drug) Clinical Trial Eligibility Overview. Trial Name: NCT05183204 — Phase 2

Glioblastoma Research Study Groups: Arm 1: Newly diagnosed MGMT unmethylated glioblastoma, Arm 2: Recurrent glioblastoma, regardless of methylation status

Glioblastoma Clinical Trial 2023: Metformin Highlights & Side Effects. Trial Name: NCT05183204 — Phase 2

Metformin (Anti-diabetic drug) 2023 Treatment Timeline for Medical Study. Trial Name: NCT05183204 — Phase 2

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

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."

Answered by AI

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."

Answered by AI

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."

Answered by AI

Recent research and studies

clinicaltrials.govStudy

Paxalisib With a High Fat, Low Carb Diet and Metformin for Glioblastoma

2022. "Paxalisib With a High Fat, Low Carb Diet and Metformin for Glioblastoma". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT05183204.

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