Study on Ivosidenib for Patients with Advanced or Metastatic Chondrosarcoma, Untreated or Treated with One Prior Systemic Therapy

Sponsor: Servier Bio-Innovation LLC

Sponsor score: 0
Inactive

ClinicalTrials ID:NCT06127407

Provider View

This clinical trial is testing the effectiveness of the drug ivosidenib in patients with advanced or metastatic chondrosarcoma, a type of bone cancer, who have not received treatment or have had only one prior treatment. The study aims to see if ivosidenib can help slow down the progression of the disease.

Patient Parameters

Program Overview

The purpose of this study is to evaluate the safety and effectiveness of ivosidenib, a medication taken by mouth, in patients with advanced or metastatic chondrosarcoma, a type of bone cancer. Participants must have a specific gene mutation (IDH1) and have either not been treated or have received only one prior treatment for their cancer. The study will compare ivosidenib to a placebo to see if it can help slow down the progression of the disease and improve survival rates.

Eligibility Criteria

Inclusion Criteria

  • Have a confirmed diagnosis of advanced or metastatic chondrosarcoma (Grades 1, 2, or 3) that cannot be surgically removed.
  • Have at least one measurable tumor that can be tracked using standard criteria.
  • Have received no more than one prior treatment for advanced/metastatic chondrosarcoma.
  • Have a tumor that has grown or returned after previous treatment, as confirmed by imaging tests.
  • Have a specific IDH1 gene mutation, confirmed by lab tests.
  • Have recovered from any side effects of previous cancer treatments.

Exclusion Criteria

  • Cannot swallow pills.
  • Are pregnant or breastfeeding.
  • Are participating in another treatment study.
  • Have previously been treated with an IDH1 inhibitor.
  • Have received cancer treatment or radiation therapy within two weeks before starting the study.
  • Have untreated or symptomatic brain metastases requiring high doses of steroids.
  • Have had another type of cancer, except for certain skin cancers or other cancers that have been treated and are not expected to affect the current diagnosis.
  • Have had major surgery within four weeks before starting the study.
  • Have significant heart disease or heart failure within six months before starting the study.
  • Have a low heart function or abnormal heart rhythm as determined by specific tests.
  • Have a history of a rare brain infection called progressive multifocal leukoencephalopathy (PML).

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