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BPM31510 + Vitamin K1 for Glioblastoma

Phase 2

Recruiting

Research Sponsored by Berg, LLC

Eligibility Criteria Checklist

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

Must have

Subjects with newly diagnosed pathologically verified GB

Karnofsky performance score ≥60

Timeline

Screening 3 weeks

Treatment Varies

Follow Up 5 years

Awards & highlights

Study Summary

This trial will study the effects of adding a new drug, BPM31510, to standard radiation and chemotherapy treatment for newly diagnosed glioblastoma patients.

Who is the study for?

This trial is for adults over 18 with newly diagnosed glioblastoma who haven't had prior treatments like radiation or chemotherapy. They should be able to understand the study and consent, have a life expectancy of at least 3 months, and a Karnofsky score of 60 or more. Participants must not be pregnant, avoid pregnancy during the trial, and be two weeks post-surgery.Check my eligibility

What is being tested?

The study tests BPM31510 combined with Vitamin K1 alongside standard treatment (radiation therapy and TMZ chemotherapy) for glioblastoma. It's an open-label Phase 2 trial where all participants receive this combination to see how effective it is compared to traditional methods alone.See study design

What are the potential side effects?

Potential side effects are not explicitly listed in the provided information but may include typical reactions associated with chemotherapy such as nausea, fatigue, hair loss; radiation therapy like skin irritation; plus any specific effects related to BPM31510 or Vitamin K1.

Eligibility Criteria

Inclusion Criteria

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

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I have been newly diagnosed with a glioblastoma.

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I can care for myself but may need occasional help.

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I haven't received any treatment for my current cancer lesion.

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I am 18 years old or older.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ 5 years

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~5 years

This trial's timeline: 3 weeks for screening, Varies for treatment, and 5 years for reporting.

Treatment Details

Study Objectives

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

Primary outcome measures

Efficacy will be assessed by subject progression free survival

Secondary outcome measures

Efficacy will be assessed by subject Overall survival

Safety and tolerability of BPM31510 and Vitamin K1 will be assessed by incidence of dose limiting toxicities (DLTs) and adverse events (AEs).

Trial Design

1Treatment groups

Experimental Treatment

Group I: BPM31510, Vitamin K1, RT and TMZExperimental Treatment4 Interventions

Subjects will receive a BPM31510 96hr infusion once weekly for 8 wk. Prophylactic Vitamin K1 at a recommended dose of 10 mg will be given intramuscular (IM) to all subjects prior to the beginning of each week of therapy. After 2 wk of treatment with BPM31510, subjects will start concurrent standard RT and TMZ 75 mg/m2 once daily (qd) × 42 days. Subjects will receive the standard TMZ treatment for additional 6 cycles post BPM31510 treatment.

Treatment

First Studied

Drug Approval Stage

How many patients have taken this drug

Radiation

2003

Completed Phase 3

~1020

Temozolomide (TMZ)

2005

Completed Phase 3

~760

0 / 4Eligibility criteria met

Find a Location

Who is running the clinical trial?

Berg, LLCLead Sponsor

12 Previous Clinical Trials

2,189 Total Patients Enrolled

BPGbioUNKNOWN

Media Library

BPM31510 (Other) Clinical Trial Eligibility Overview. Trial Name: NCT04752813 — Phase 2

Glioblastoma Research Study Groups: BPM31510, Vitamin K1, RT and TMZ

Glioblastoma Clinical Trial 2023: BPM31510 Highlights & Side Effects. Trial Name: NCT04752813 — Phase 2

BPM31510 (Other) 2023 Treatment Timeline for Medical Study. Trial Name: NCT04752813 — Phase 2

Frequently Asked Questions

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

Has the FDA cleared radiation for use in treatment?

"The safety of radiation is estimated to be a 2. This is due to the fact that this is a phase 2 trial, which only provides some data supporting safety and no efficacy."

Answered by AI

What conditions are often treated with Radiation?

"Radiation is commonly used to treat patients with nitrosourea treatment. However, it can also be employed to ameliorate other conditions such as refractory neuroblastoma, mycosis fungoides, and advanced directives."

Answered by AI

Has there been anything like this experiment done before?

"Radiation has been studied since 2002, with the first clinical trial sponsored by Schering-Plough. After this initial study involving 60 patients, Radiation received Phase 2 drug approval and today there are 218 active studies taking place in 947 cities across 36 countries."

Answered by AI

How many people can join this research project?

"Yes, the data on clinicaltrials.gov indicates that this clinical trial is presently recruiting candidates. The study was first posted on 8/2/2021 and was last edited on 5/31/2022. The study is enrolling 50 participants at 3 locations."

Answered by AI

Are researchers looking for more trial participants at this time?

"The answer is affirmative, as the clinical trial in question is actively recruiting patients according to the information provided on clinicaltrials.gov. This specific trial was first posted on 8/2/2021 and has been edited most recently on 5/31/2022. There are plans to admit 50 individuals at 3 distinct locations."

Answered by AI

What other scientific papers have been published on the topic of Radiation?

"There are currently 218 clinical trials underway that focus on research surrounding the use of radiation as a treatment. Of those, 25 have reached Phase 3. These numerous trials originate from 4820 locations with the majority being based in Seoul and Songpa."

Answered by AI

Recent research and studies

clinicaltrials.govStudy

A Study of BPM31510 With Vitamin K1 in Subjects With Newly Diagnosed Glioblastoma (GB)

2022. "A Study of BPM31510 With Vitamin K1 in Subjects With Newly Diagnosed Glioblastoma (GB)". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT04752813.

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