Advanced Renal Cell Carcinoma
Conditions
Interventions
investigational material(s)
Generic name etc : Cabozantinib
INN of investigational material : Cabozantinib
Therapeutic category code : 429 Other antitumor agents
Dosage and Administration for Investig
Sponsors
Takeda Pharmaceutical Company Limited
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: - Male or female Japanese patients 20 years of age or older on the day of consent. - Documented histological or cytological diagnosis of RCC with a clear-cell component. - Measurable disease per response evaluation criteria in solid tumors version 1.1 (RECIST V 1.1) as determined by the investigator. - Must have received at least one VEGFR-targeting TKI (eg, sorafenib, sunitinib, axitinib, pazopanib or tivozanib). - For the most recently received VEGFR-targeting TKI the following criteria must apply: 1. Must have radiographically progressed during treatment, or been treated for at least 4 weeks and radiographically progressed within 6 months after the last dose. Radiographic progression is defined as unequivocal progression of existing tumor lesions or developing new tumor lesions as assessed by the investigator on computerized tomography (CT) or magnetic resonance imaging (MRI) scans. 2. The last dose must have been within 6 months before the first day of study drug administration (Week 1 Day 1). - Recovery to baseline or =- Karnofsky Performance Status (KPS) score of >=70%. - Adequate organ and marrow function at Screening.
Exclusion criteria
Exclusion criteria: - Prior treatment with everolimus, or any other specific or selective target of rapamycin complex 1 /phosphoinositide 3-kinase/AKT inhibitor (eg, temsirolimus), or cabozantinib. - Receipt of any type of small-molecule kinase inhibitor (including investigational kinase inhibitor) within 14 days before Week 1 Day 1. - Receipt of any type of anticancer antibody (including investigational antibody) within 28 days before Week 1 Day 1. - Radiation therapy for bone metastasis within 14 days, and/or any other external radiation therapy within 28 days before Week 1 Day 1. Systemic treatment with radionuclides within 42 days before Week 1 Day 1. Patients with clinically relevant ongoing complications from prior radiation therapy are not eligible.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| efficacy Objective Response Rate (ORR) Timeframe; From first dose of study drug up to disease progression or death (up to 2.5 years) ORR was defined as the percentage of participants whose best overall response was complete response rate (CR) or partial response (PR) evaluated by independent review committee (IRC) per 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. | — |
Secondary
| Measure | Time frame |
|---|---|
| efficacy Clinical Benefit Rate (CBR) Timeframe; From first dose of study drug up to disease progression or death (up to 2.5 years) CBR was defined as participants whose best overall response is CR, PR or stable disease (SD) per RECIST 1.1. Response and progression is 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 progressive disease (PD). efficacy Progression-Free Survival (PFS) Timeframe; From first dose of study drug up to disease progression or death (up to 2.5 years) PFS was defined as time from the first day of study drug administration to the earlier of PD, per RECIST 1.1 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. efficacy Overall Survival (OS) Timeframe; From first dose of study drug up to disease progression or death (up to 2.5 years) OS is defined as time from the first day of study drug administration to death due to any cause. safety Percentage of participants with Treatment-Emergent Adverse Events (TEAEs) Timeframe; From the signing of the informed consent form up to 30 days after the last dose of the study drug (up to 2.6 years) An AE was defined as any untoward medical occurrence in a clinical investigation participant administered a drug; it does not | — |
Countries
Japan
Outcome results
None listed