A Phase 2 Study of Cabozantinib in Japanese Participants With Advanced Renal Cell Carcinoma

A Phase 2, Open-Label, Single-Arm Study of Cabozantinib in Japanese Patients With Advanced Renal Cell Carcinoma That Has Progressed After Prior VEGFR Tyrosine Kinase Inhibitor Therapy

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.

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.