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BPM31510 + Vitamin K1 for Glioblastoma

Phase 2

Recruiting

Research Sponsored by BPGbio

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

Must not have

Receiving Digoxin, digitoxin, lanatoside C, or any type of digitalis alkaloids

Uncontrolled or severe coagulopathies or a history of clinically significant bleeding within the past 6 months

Timeline

Screening 3 weeks

Treatment Varies

Follow Up 5 years

Awards & highlights

No Placebo-Only Group

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.

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.

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.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:

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I am currently taking heart medication such as Digoxin.

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I haven't had serious bleeding or uncontrollable bleeding disorders in the last 6 months.

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I have a condition that makes me bleed easily, like von Willebrand's disease.

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I am not taking warfarin but am on other blood thinners.

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I am currently taking Theophylline.

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My latest tests show no remaining cancer.

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I have a history of serious heart problems.

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I have had a significant brain bleed due to my tumor.

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

Study objectives can provide a clearer picture of what you can expect from a treatment.

Primary study objectives

Efficacy will be assessed by subject progression free survival

Secondary study objectives

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).

Awards & Highlights

No Placebo-Only Group

All patients enrolled in this study will receive some form of active treatment.

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 2

~780

Temozolomide (TMZ)

2005

Completed Phase 3

~760