Clinical Trial DRUG CBGJ398X2201
- A Phase 2, Multicenter, Open-Label Study Of BGJ398 in Patients with Recurrent Resectable or Unresectable Glioblastoma
- Principal Investigator
- Jeffrey Raizer
- Status: Accepting New Patients
- Study Type: Therapeutic, Treatment
- Protocol No:.DRUG CBGJ398X2201
- The main purpose of this study is to find out if BGJ398 is safe and if it is effective in treating glioblastoma.
- The study drug BGJ398 is a medicine which has not been approved by the Food and Drug Administration (FDA) for the treatment of glioblastoma and is currently not “on the market” (available to buy) in any country. BGJ398 is developed by the company Novartis (the study sponsor). BGJ398 binds and blocks a family of proteins called fibroblast growth factor receptor (FGFR). FGFRs are part of pathway (a series of chemical reactions between proteins) that helps cells to function normally. In some types of cancers, this pathway becomes too active, which can cause tumor cell growth. BGJ398 has been shown to stop cancers in laboratory and animal studies and is being tested in human clinical studies.
Some of the eligibility criteria include:
- Participants must have glioblastoma that has returned after prior surgery.
- Participants must have received prior external beam radiotherapy and temozolomide.
- Participants must be 18 or older.
- Description of Treatment
- Study participants will be enrolled in one of two groups. Group 1 will enroll patients who are not eligible for surgical resection of their tumor. Group 2 will enroll patients who will have surgery as part of their routine care. A treatment cycle consists of 28 days. During each 28-day cycle participants will take BGJ398 once a day on days 1 through 21. Participants who will undergo surgery will receive BGJ398 once daily for 5-10 days before surgery. After the surgery, and based on the Study Doctor’s judgment, participants will resume treatment and receive BGJ398 once daily in a 28 days cycle (three weeks on and one week off).
- Sara Duffey
Clinical Research and Education Specialist
Robert H. Lurie Comprehensive Cancer Center
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last updated: 30-Nov-15 03:48 AM
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