A Study to Evaluate the Efficacy and Safety of Rivoceranib in Participants With Recurrent or Metastatic Adenoid Cystic Carcinoma (ACC)
NCT04119453 · Status: TERMINATED · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 80
Last updated 2024-06-24
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
- DRUG
-
Rivoceranib
Film-coated tablets
Sponsors & Collaborators
-
Elevar Therapeutics
lead INDUSTRY
Study Design
- Allocation
- NA
- Purpose
- TREATMENT
- Masking
- NONE
- Model
- SINGLE_GROUP
Eligibility
- Min Age
- 18 Years
- Sex
- ALL
- Healthy Volunteers
- No
Timeline & Regulatory
- Start
- 2020-01-22
- Primary Completion
- 2023-06-28
- Completion
- 2023-06-28
- FDA Drug
- Yes
Countries
- United States
- South Korea
Study Locations
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