Safusidenib Phase 2 Study in IDH1 Mutant Glioma
Trial ID or NCT#
Status
RECRUITING
Purpose
This is a 2-part study. The purpose of Part 1 of the study is to evaluate the efficacy, safety, and pharmacokinetic (PK) characteristics of safusidenib in participants with recurrent/progressive IDH1-mutant World Health Organization (WHO) Grade 2 or Grade 3 glioma. The purpose of Part 2 will be to evaluate the efficacy of maintenance safusidenib treatment versus placebo in IDH1-mutant Grade 3 astrocytoma with high-risk features or Grade 4 IDH1-mutant astrocytoma, following standard-of-care radiation or chemoradiation and adjuvant temozolomide. Part 2 will be randomized, double blind, and placebo controlled.
Official Title
A Phase 2, Multicenter, Clinical Study to Evaluate the Efficacy and Safety of Safusidenib Erbumine in Patients With Isocitrate Dehydrogenase 1 (IDH1) Mutant Glioma
Eligibility Criteria
- 1. Patients with history or complication of any of the following diseases within 6 months prior to the initial dose of safusidenib:
- * Myocardial infarction * Severe or unstable angina pectoris * Coronary or peripheral endovascular treatment * Heart failure * Cerebrovascular disorder including transient ischemic attack, stroke, central nervous system (CNS) bleeding.2. Uncontrolled active systemic fungal, bacterial, or other infection (despite appropriate antibiotics or other treatment).3. Gastrointestinal diseases that may interfere with oral ingestion of safusidenib or may affect absorption of safusidenib.4. Psychiatric disease or symptoms that may interfere with the patient's continuous participation in the study.5. Patients should be tested for severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) and those with active infection detected using either molecular or antigen tests in accordance with local testing guidelines will be excluded.6. Prior anti-cancer therapy, within the applicable periods shown below, before the start of the protocol treatment:
- * Systemic drug therapies: within 3 weeks (lomustine within 6 weeks) * Surgery: within 3 weeks * Radiation therapy: within 12 weeks * Investigational agents: within 5 half-lives for other investigational agents7. Patient did receive the prior therapy targeted to IDH1 mutation.8. Patients taking substrates of cytochrome CYP2C8, CYP2C9, and CYP3A4 (See Appendix 7) with narrow therapeutic window, should be excluded unless they can be transferred to other medications prior to enrolling. Patients taking sensitive CYP 2C8, 2C9 or 3A4 substrate medications may require dosage adjustment unless they can be transferred to other medications within ≥ 5 half-lives prior to dosing.9. Patients taking sensitive substrates of P-gp and BCRP transporters (See Appendix 7) should be excluded unless they can be transferred to other medications prior to enrolling.
- Patients taking sensitive substrates of P-gp and BCRP may require dosage adjustment unless they can be transferred to other medications within ≥ 5 half-lives prior to dosing.10. Advanced arrhythmia of Grade ≥ 2 per NCI-CTCAE v5.0, uncontrolled atrial fibrillation (any grade) and corrected QT interval by Fredericia's formula (QTcF) \> 470 msec.11. Evidence of intraspinal dissemination or diffuse leptomeningeal disease by MRI.12. Positive test results for human immunodeficiency virus (HIV) antibody.13. Positive test results for hepatitis B surface (HBs) antigen and/or hepatitis C virus (HCV) antibody. Patients who have tested positive for hepatitis B core (HBc) antibody and/or HBs antibody, despite negative test results for HBs antigen, may be enrolled only if they have negative finding on quantitative hepatitis B virus (HBV) DNA assays and the Anti-HBV treatment is allowing during study period. Patients who are hepatitis C antibody positive will need to have a negative polymerase chain reaction (PCR) result before enrollment; those who are hepatitis C PCR positive will be excluded.14. Pregnant or breastfeeding female patient.15. Known hypersensitivity to safusidenib or to any drug with similar chemical structure or to any other excipient present in the pharmaceutical form of safusidenib.
Investigator(s)
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Contact
Hari Priya Yerraballa
650-724-9363
View on ClinicalTrials.gov
