Phase 2 Study of Safusidenib for IDH1 Mutant Glioma

Sponsor: AnHeart Therapeutics Inc.

Sponsor score: 0
Inactive

ClinicalTrials ID:NCT05303519

Provider View

This clinical trial is testing the effectiveness and safety of a drug called safusidenib in patients with a specific type of brain tumor known as IDH1 mutant glioma. The study is divided into two parts and includes patients with recurrent or worsening Grade 2 or 3 glioma.

Patient Parameters

Program Overview

This study is exploring the use of safusidenib, a medication taken by mouth, to treat patients with a type of brain tumor called IDH1 mutant glioma. The trial is in Phase 2 and involves multiple centers. It is open-label, meaning both the researchers and participants know what treatment is being given. The study is divided into two parts. In Part 1, up to 25 patients will be randomly assigned to receive different doses of safusidenib to assess its safety and how the body processes the drug. In Part 2, 60 patients will be divided into two groups based on their tumor grade to evaluate the drug's effectiveness. An additional exploratory group will study the effects of safusidenib on different types of tumor lesions. Participants will continue treatment until their disease progresses, they experience unacceptable side effects, or they choose to withdraw from the study.

Eligibility Criteria

Inclusion Criteria

  • Must be 18 years or older.
  • Have a confirmed diagnosis of recurrent or worsening Grade 2 or 3 glioma with a specific IDH1 mutation.
  • Have available tumor samples for testing.
  • Have received no more than two previous treatments for tumor recurrence or progression.
  • Have a measurable tumor as defined by specific criteria.
  • Have a life expectancy of at least 3 months.
  • Have a Karnofsky Performance Status (KPS) score of 60 or higher, indicating the ability to care for oneself with some assistance.
  • Have adequate organ function based on specific blood test results.
  • Women must use effective birth control methods if of childbearing potential.
  • Men must agree to use condoms during sexual activity with women of childbearing potential.
  • Be willing to provide written consent and undergo study procedures.

Exclusion Criteria

  • Have had certain heart conditions or strokes within the last 6 months.
  • Have uncontrolled infections.
  • Have digestive issues that affect the absorption of the medication.
  • Have psychiatric conditions that interfere with study participation.
  • Test positive for active COVID-19 infection.
  • Have received certain cancer treatments within specified timeframes before starting the study.
  • Have previously received treatment targeting the IDH1 mutation.
  • Are taking certain medications that interact with the study drug.
  • Have certain heart rhythm issues or a prolonged QT interval on an ECG.
  • Have cancer spread to the spine or brain lining.
  • Test positive for HIV or active hepatitis B or C infections.
  • Are pregnant or breastfeeding.
  • Have allergies to safusidenib or similar drugs.

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