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A Phase 2 Open-Label, Multicenter, Study to Evaluate the Efficacy and Safety of Rivoceranib in Subjects with Recurrent or Metastatic Adenoid Cystic Carcinoma of All Anatomic Sites of Origin
This is a Phase 2, multicenter, open-label, single-arm study of rivoceranib to evaluate its efficacy and safety in adult subjects with metastatic ACC of all anatomic sites of origin.
Primary Objective: To evaluate the efficacy of rivoceranib in subjects with recurrent or metastatic adenoid cystic adenocarcinoma (ACC) based on assessment of objective response rate (ORR). Secondary Objective: To further evaluate the efficacy in subjects with recurrent or metastatic ACC: Overall survival (OS), Disease control rate (DCR), Progression free survival (PFS) and Time to progression (TTP). To evaluate the safety of rivoceranib. Exploratory Objectives: To explore pharmacodynamics markers, to evaluate the pharmacokinetics (PK) of revoceranib. To evaluate quality of life measurements during treatment with rivoceranib.