The purpose of this study is to evaluate the efficacy of cabozantinib measured by Independent Radiology Committee (IRC)-assessed objective response rate (ORR) in Japanese participants with advanced renal cell carcinoma (RCC) that has progressed after prior vascular endothelial growth factor receptor (VEGFR) tyrosine kinase inhibitor (TKI) therapy.
The drug being tested in this study is called cabozantinib. Cabozantinib is being tested to treat people who have advanced renal cell carcinoma. This study will look at the efficacy of cabozantinib. The study will enroll approximately 35 patients. Participants will be enrolled in one treatment group in non-randomized and opened manner: • Cabozantinib 60 mg All participants will be asked to take tablets of cabozantinib at once daily in the fasted state throughout the study. This multi-center trial will be conducted in Japan. The overall time to participate in this study is approximately at most 3 years. Participants will make multiple visits to the clinic in treatment period, and posttreatment period including a follow-up assessment after last dose of study drug.
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
TREATMENT
Masking
NONE
Enrollment
35
Cabozantinib tablets
Nagoya University Hospital
Nagoya, Aichi-ken, Japan
Hokkaido University Hospital
Sapporo, Hokkaido, Japan
Objective Response Rate (ORR)
ORR was defined as the percentage of participants whose best overall response was complete response (CR) or partial response (PR) evaluated by the independent review committee (IRC) per response evaluation criteria in solid tumors version 1.1 (RECIST V1.1) which was confirmed by a subsequent evaluation conducted ≥28 days later. Per RECIST V1.1, CR was defined as the disappearance of all lesions, and all pathological lymph nodes (whether target or nontarget) must have a reduction in short axis to \<10 millimeter (mm). PR was defined as at least a 30% decrease in the sum of diameter (SoD) of target lesions, taking as a reference the Baseline SoD.
Time frame: From first dose of study drug up to first documentation of CR or PR (up to 2.5 years)
Clinical Benefit Rate (CBR)
CBR was defined as percentage of participants whose best overall response is CR, PR, or stable disease (SD) per RECIST V1.1. Response and progression were evaluated by IRC per RECIST V1.1. CR and PR required confirmation by a subsequent evaluation conducted ≥28 days later and an assessment of SD was made at least 8 weeks after the first day of study drug. Per RECIST V1.1, CR was defined as the disappearance of all lesions, and all pathological lymph nodes (whether target or nontarget) must have a reduction in the short axis to \<10 mm. PR was defined as at least a 30% decrease in SoD of target lesions, taking as a reference the Baseline SoD. SD was defined as neither sufficient shrinkage to qualify for PR nor sufficient increase to qualify for PD.
Time frame: From first dose of study drug up to first documentation of CR or PR or SD (up to 2.5 years)
Progression-Free Survival (PFS)
PFS was defined as the time from the first day of study drug administration to the earlier of progressive disease (PD) per RECIST V1.1 or death due to any cause. Per RECIST V1.1, PD was defined at least a 20% increase in the SoD of target lesions, taking as a reference the smallest (nadir) SoD since (and including) Baseline. In addition to the relative increase of 20%, the SoD also demonstrated an absolute increase of at least 5 mm.
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Sapporo Medical University Hospital
Sapporo, Hokkaido, Japan
Kobe University Hospital
Kobe, Hyōgo, Japan
Yokohama City University Hospital
Yokohama, Kanagawa, Japan
Yokohama City University Medical Center
Yokohama, Kanagawa, Japan
Kindai University Hospital
Sayama, Osaka, Japan
Osaka University Hospital
Suita, Osaka, Japan
Nippon Medcal School Hospital
Bunkyo-ku, Tokyo, Japan
Toranomon Hospital
Minato-ku, Tokyo, Japan
...and 9 more locations
Time frame: From first dose of study drug up to disease progression or death (up to 2.5 years)
Overall Survival (OS)
OS is defined as the time from the first day of study drug administration to death due to any cause.
Time frame: From first dose of study drug up to death due to any cause (up to 2.5 years)
Percentage of Participants With Treatment-Emergent Adverse Events (TEAEs)
An AE was defined as any untoward medical occurrence in a clinical investigation participant administered a drug; it does not necessarily have to have a causal relationship with this treatment. TEAEs were defined as AEs whose date of onset occurs on or after the start of study drug and within 30 days after the last dose of study treatment.
Time frame: From first dose up to 30 days after the last dose of the study drug (up to 2.6 years)
Percentage of Participants With Grade 3 or Higher TEAEs
An AE was defined as any untoward medical occurrence in a clinical investigation participant administered a drug; it does not necessarily have to have a causal relationship with this treatment. TEAEs were defined as AEs whose date of onset occurs on or after the start of study drug and within 30 days after the last dose of study treatment. Severity grade was defined by the National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE) version 4.03. As per the NCI-CTCAE, Grade 1 scales as mild; Grade 2 scales as moderate; Grade 3 scales as severe or medically significant but not immediately life-threatening; Grade 4 scales as life-threatening consequences; and Grade 5 scales as death related to AE.
Time frame: From first dose up to 30 days after the last dose of the study drug (up to 2.6 years)
Percentage of Participants With Serious TEAEs
A serious TEAE was any untoward medical occurrence or effect that at any dose resulted in death, was life-threatening, required inpatient hospitalization or prolongation of existing hospitalization, resulted in persistent or significant disability/incapacity, was a congenital anomaly/birth defect, or was medically important due to other reasons than the above-mentioned criteria. TEAEs were defined as AEs whose date of onset occurs on or after the start of study drug and within 30 days after the last dose of study treatment.
Time frame: From first dose up to 30 days after the last dose of the study drug (up to 2.6 years)
Percentage of Participants With TEAEs Leading to Permanent Treatment Discontinuation
An AE was defined as any untoward medical occurrence in a clinical investigation participant administered a drug; it does not necessarily have to have a causal relationship with this treatment. TEAEs were defined as AEs whose date of onset occurs on or after the start of study drug and within 30 days after the last dose of study treatment.
Time frame: From first dose up to 30 days after the last dose of the study drug (up to 2.6 years)
Percentage of Participants With TEAEs Leading to Dose Modification (Dose Reduction or Interruption)
An AE was defined as any untoward medical occurrence in a clinical investigation participant administered a drug; it does not necessarily have to have a causal relationship with this treatment. TEAEs were defined as AEs whose date of onset occurs on or after the start of study drug and within 30 days after the last dose of study treatment.
Time frame: From first dose up to 30 days after the last dose of the study drug (up to 2.6 years)
Percentage of Participants With Clinically Significant Abnormal Laboratory Values
Clinical laboratory tests included tests of serum chemistry, hematology, urine chemistry, coagulation, and thyroid function prespecified in the protocol. Only those categories are reported which are considered clinically significant abnormal laboratory values post baseline, as assessed by the investigator.
Time frame: From first dose up to 30 days after the last dose of the study drug (up to 2.6 years)
Percentage of Participants With Clinically Significant Abnormal Vital Sign
Vital signs included diastolic blood pressure (DBP) and systolic blood pressure (SBP) in the sitting position, pulse rate respiratory rate temperature, and weight. Abnormal vital sign values considered by the investigator to be clinically significant are reported as categories.
Time frame: From first dose up to 30 days after the last dose of the study drug (up to 2.6 years)