NCT04119453

A Study to Evaluate the Efficacy and Safety of Rivoceranib in Participants With Recurrent or Metastatic Adenoid Cystic Carcinoma (ACC)

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

• Status: Terminated
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 80 (actual)
• Sponsor: Elevar Therapeutics · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

The purpose of this study is to evaluate the efficacy and safety of rivoceranib in adult participants with recurrent or metastatic ACC. All participants may remain on treatment until occurrence of disease progression, unacceptable toxicity, death, the withdrawal of consent from treatment, lost to follow-up or study termination by the Sponsor. When a participant discontinues rivoceranib for any reason, the participant will enter the 24 month survival follow up period until withdrawal of consent from the study, lost to follow up, end of the study or death, whichever occurs earlier. The maximum duration of the study is estimated to be 48 months and includes screening, treatment, and follow-up phases.

Conditions

• Adenoid Cystic Carcinoma

Interventions

Type	Name	Description
DRUG	Rivoceranib	Film-coated tablets

Timeline

• Start date: 2020-01-22
• Primary completion: 2023-06-28
• Completion: 2023-06-28
• First posted: 2019-10-08
• Last updated: 2024-06-24

Locations

11 sites across 2 countries: United States, South Korea

Regulatory

• FDA-regulated drug study