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Brief Title: A Study to Evaluate the Efficacy and Safety of Rivoceranib in Participants With Recurrent or Metastatic Adenoid Cystic Carcinoma (ACC)
Official Title: 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
Study ID: NCT04119453
Brief 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.
Detailed Description:
Minimum Age: 18 Years
Eligible Ages: ADULT, OLDER_ADULT
Sex: ALL
Healthy Volunteers: No
University of California, Los Angeles (UCLA), Los Angeles, California, United States
UCSF, San Francisco, California, United States
University of Colorado Denver, Denver, Colorado, United States
H. Lee Moffitt Cancer Center & Research Institute, Tampa, Florida, United States
Dana-Farber Cancer Institute - Head and Neck Oncology, Boston, Massachusetts, United States
University of Michigan, Ann Arbor, Michigan, United States
Memorial Sloan Kettering Cancer Center, New York, New York, United States
National Cancer Center, Goyang-si, Gyeonggi-do, Korea, Republic of
Seoul National University Hospital, Seoul, Gyeonggi-do, Korea, Republic of
Asan Medical Center, Seoul, Gyeonggi, Korea, Republic of
Samsung Medical Center, Seoul, , Korea, Republic of