drugset / Trial / NCT04745832
Phase 3 Study of Zandelisib (ME-401) in Combination With Rituximab in Patients With iNHL - (COASTAL)
RandomizedParallel-groupOpen-labelTreatment
Summary
This is a Phase 3 study of the PI3Kδ inhibitor Zandelisib (ME-401) in combination with rituximab, in comparison to standard immunochemotherapy (Rituximab-Bendamustine or Rituximab-CHOP) in subjects with relapsed or refractory FL and MZL.
Timeline
- Start
- 2021-08-13
- Primary completion
- 2023-03-20
- Completion
- 2023-03-20
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Subject | Bendamustine | Small molecule | 90 mg/m2 | Intravenous |
| Subject | Cyclophosphamide | Other / unclassified | 750 mg/m2 | Intravenous |
| Subject | Prednisone | Other / unclassified | 100 mg | Oral |
| Subject | Vincristine | Small molecule | 1.4 mg/m2 | Intravenous |
| Subject | Zandelisib | Small molecule | 60 mg | Oral |
| Subject | hydroxydoxorubicin | Unknown | 50 mg/m2 | Intravenous |
| Background | Rituximab | Monoclonal antibody | 375 mg/m2 | Intravenous |