A Phase 2 Study of Cabozantinib in Japanese Participants With Advanced Renal Cell Carcinoma
Condition: Advanced Renal Cell Carcinoma
MeSH terms: Carcinoma; Carcinoma, Renal Cell
Intervention: Cabozantinib
Intervention description: Cabozantinib tablets
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Intervention model: Single Group Assignment
Masking: None (Open Label)
Enrollment: 35.0
Sex: All
Minimum age: 20 Years
Healthy volunteers: No
Keywords: Drug Therapy

Summary:

      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.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Male or female Japanese participants 20 years of age or older on the day of consent.

          -  Documented histological or cytological diagnosis of renal cell carcinoma (RCC) with a
             clear-cell component.

          -  Measurable disease per RECIST 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:

               -  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.

        - 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 ≤Grade 1 Common Terminology Criteria for Adverse Events
             (CTCAE) Version 4.03 from toxicities related to any prior treatments, unless AE(s) are
             clinically nonsignificant and/or stable on supportive therapy.

          -  Karnofsky Performance Status (KPS) score of ≥70%.

          -  Adequate organ and marrow function at Screening.

        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.

        Participants with clinically relevant ongoing complications from prior radiation therapy
        are not eligible.