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.
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
TREATMENT
Masking
NONE
Enrollment
80
Film-coated tablets
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, South Korea
Asan Medical Center
Seoul, Gyeonggi-do, South Korea
Seoul National University Hospital
Seoul, Gyeonggi-do, South Korea
...and 1 more locations
Objective Response Rate (ORR): Percentage of Participants Who Achieved Confirmed Complete Response (CR) or Partial Response (PR) Per the Response Evaluation Criteria in Solid Tumors (RECIST) 1.1 by Investigator/Institutional Assessment
Complete Response - Disappearance of all target lesions. Any pathological lymph nodes (whether target or non-target) must have reduction in short axis to \<10 millimeters (mm) (the sum may not be "0" if there are target nodes). Partial Response - At least a 30% decrease in the sum of the diameters of target lesions, taking as reference the baseline sum diameters.
Time frame: Up to 41 months
ORR: Percentage of Participants Who Achieve Confirmed CR or PR Per RECIST 1.1 by Independent Central Review
CR - Disappearance of all target lesions. Any pathological lymph nodes (whether target or non-target) must have reduction in short axis to \<10 mm (the sum may not be "0" if there are target nodes). PR - At least a 30% decrease in the sum of the diameters of target lesions, taking as reference the baseline sum diameters.
Time frame: Up to 41 months
Overall Survival (OS) Rate
OS was defined as the interval from the start of study therapy to death from any cause. Here, the percentage of participants with OS at specified time points are shown.
Time frame: Months 12 and 24
Progression Free Survival (PFS) Rate at 6 Months, 12 Months, and 2 Years by Investigator or Institutional Assessment
PFS was defined as the time from the start of treatment with rivoceranib to the first evaluation showing Progressive Disease (PD) or death, whichever occurred first. Participants who did not experience PD or death were censored at the date of last disease assessment. Here, the percentage of participants with PFS at the given timepoints is shown. PD - At least a 20% increase in the sum of diameters of target lesions, taking as reference the smallest sum on study (this includes the baseline sum if that is the smallest on study). In addition to the relative increase of 20%, the sum must also demonstrate an absolute increase of at least 5 mm. (Note: the appearance of one or more new lesions is also considered progression.)
Time frame: Months 6, 12, and 24
Progression Free Survival (PFS) at 6 Months, 12 Months, and 2 Years Evaluated by Independent Central Review
PFS was defined as the time from the start of treatment with rivoceranib to the first evaluation showing PD or death, whichever occured first. Participants who do not experience PD or death were censored at the date of last disease assessment. Here, the percentage of participants with PFS at the given timepoints is shown. PD - At least a 20% increase in the sum of diameters of target lesions, taking as reference the smallest sum on study (this includes the baseline sum if that is the smallest on study). In addition to the relative increase of 20%, the sum must also demonstrate an absolute increase of at least 5 mm. (Note: the appearance of one or more new lesions is also considered progression.)
Time frame: Months 6 and 12, and Year 2
Duration of Response (DoR) Per RECIST Version 1.1 by Investigator or Institutional Assessment
Duration of response was the time from the first response of PR or CR (which was subsequently confirmed) to the first evaluation showing PD or death, whichever occurred first. Death due to any cause was considered in the determination of DOR. CR - Disappearance of all target lesions. Any pathological lymph nodes (whether target or non-target) must have reduction in short axis to \<10 mm (the sum may not be "0" if there are target nodes). PR - At least a 30% decrease in the sum of the diameters of target lesions, taking as reference the baseline sum diameters. PD - At least a 20% increase in the sum of diameters of target lesions, taking as reference the smallest sum on study (this includes the baseline sum if that is the smallest on study). In addition to the relative increase of 20%, the sum must also demonstrate an absolute increase of at least 5 mm. (Note: the appearance of one or more new lesions is also considered progression.)
Time frame: Up to 41 months
Duration of Response (DoR) Per RECIST Version 1.1 Evaluated by Independent Central Review
Duration of response was the time from the first response of PR or CR (which was subsequently confirmed) to the first evaluation showing PD or death, whichever occurred first. Death due to any cause was considered in the determination of DOR. CR - Disappearance of all target lesions. Any pathological lymph nodes (whether target or non-target) must have reduction in short axis to \<10 mm (the sum may not be "0" if there are target nodes). PR - At least a 30% decrease in the sum of the diameters of target lesions, taking as reference the baseline sum diameters. PD - At least a 20% increase in the sum of diameters of target lesions, taking as reference the smallest sum on study (this includes the baseline sum if that is the smallest on study). In addition to the relative increase of 20%, the sum must also demonstrate an absolute increase of at least 5 mm. (Note: the appearance of one or more new lesions is also considered progression.)
Time frame: Up to 41 months
Time to Progression (TTP) Per RECIST Version 1.1 by Investigator or Institutional Assessment
TTP was the length of time from the start of treatment with rivoceranib until objective tumor progression. At the time of analysis of TTP, any participants who do not experience PD including participants who died without PD were censored at the date of last disease assessment. The TTP was estimated using the Kaplan-Meier method. PD - At least a 20% increase in the sum of diameters of target lesions, taking as reference the smallest sum on study (this includes the baseline sum if that is the smallest on study). In addition to the relative increase of 20%, the sum must also demonstrate an absolute increase of at least 5 mm. (Note: the appearance of one or more new lesions is also considered progression.)
Time frame: Up to 41 months
TTP Per RECIST Version 1.1 Evaluated by Independent Central Review
TTP was the length of time from the start of treatment with rivoceranib until objective tumor progression. At the time of analysis of TTP, any participants who do not experience PD including participants who died without PD were censored at the date of last disease assessment. The TTP was estimated using the Kaplan-Meier method. PD - At least a 20% increase in the sum of diameters of target lesions, taking as reference the smallest sum on study (this includes the baseline sum if that is the smallest on study). In addition to the relative increase of 20%, the sum must also demonstrate an absolute increase of at least 5 mm. (Note: the appearance of one or more new lesions is also considered progression.)
Time frame: Up to 41 months
Number of Participants With Treatment-Emergent Adverse Events (AEs)
An AE was defined as any untoward medical occurrence in a participant who received study drug without regard to possibility of causal relationship. A summary of non-serious AEs and all serious AEs, regardless of causality is located in Reported AE section.
Time frame: From first dose of rivoceranib until 30 days after the last dose date of rivoceranib or initiation of other anticancer therapy, whichever is earlier (up to 41 months)
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