Study on BPM31510 with Vitamin K1 for Patients with Newly Diagnosed Glioblastoma

Sponsor: BPGbio

Sponsor score: 0
Inactive

ClinicalTrials ID:NCT04752813

Provider View

This clinical trial is testing the addition of BPM31510 to standard treatments for patients with newly diagnosed glioblastoma, a type of brain cancer. The study aims to evaluate the safety and effectiveness of this combination therapy.

Patient Parameters

Program Overview

This study is exploring whether adding BPM31510 to the usual treatment of radiation therapy (RT) and chemotherapy with temozolomide (TMZ) can help treat patients with newly diagnosed glioblastoma, a type of brain cancer. The trial will first confirm the safe dose of BPM31510 and then assess its effectiveness when combined with standard treatments.

Description

The study begins with a phase to confirm the safe dose of BPM31510 when used with radiation therapy (RT) and chemotherapy (TMZ). This phase will use a standard approach to find the right dose, starting at 110 mg/kg per week, with a possible reduction to 66 mg/kg per week if needed. Patients will be monitored for any side effects for 30 days after finishing RT and then regularly for up to 5 years to check for any late side effects. An independent committee will oversee safety and make recommendations if dose changes are necessary. Once the safe dose is confirmed, the study will move on to test how well the treatment works.

Eligibility Criteria

Inclusion Criteria

  • Have a new diagnosis of glioblastoma confirmed by a pathologist.
  • Have not received prior radiation, chemotherapy, immunotherapy, or targeted treatments for the current tumor.
  • Be 18 years or older.
  • Have a life expectancy of at least 3 months.
  • Have a Karnofsky performance score of 60 or higher, indicating the ability to care for oneself with some assistance.
  • Have adequate organ and bone marrow function as specified in the study protocol.
  • Be able to understand and willing to sign a written informed consent form.
  • If of childbearing potential, agree to use effective birth control methods during the study.
  • Be at least 14 days post-surgery.

Exclusion Criteria

  • No remaining tumor visible after surgery.
  • History of significant bleeding in the brain related to the tumor.
  • Serious heart problems as specified in the study protocol.
  • Uncontrolled bleeding disorders or significant bleeding in the past 6 months.
  • Known bleeding disorders like von Willebrand's disease.
  • Uncontrolled other illnesses.
  • Previous cancer, except for certain skin cancers or in situ cancers, unless treated and resolved over 3 years ago.
  • Taking certain medications, including:
    • Blood thinners like warfarin.
    • Heart medications like digoxin.
    • Anti-cancer drugs like Avastin recently or planned soon.
    • Theophylline.
  • Known allergy to CoQ10 or Vitamin K1.
  • Pregnant or breastfeeding.
  • Known HIV positive status.

Get This Program In Your Inbox

Receive detailed information about this treatment opportunity to review with your healthcare provider.