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

NCT ID: NCT03339219

Last Updated: 2021-09-20

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE2
• Total Enrollment: 35 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2017-12-13
• Study Completion Date: 2020-08-25

Brief 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.

Detailed Description

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.

Conditions

Advanced Renal Cell Carcinoma

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Cabozantinib 60 mg

Cabozantinib 60 mg, tablet, orally, once daily (QD) in the fasted state until unacceptable toxicity or need for subsequent systemic anticancer treatment up to 2.5 years.

Group Type: EXPERIMENTAL

Cabozantinib

Intervention Type: DRUG

Cabozantinib tablets

Interventions

Cabozantinib

Cabozantinib tablets

Intervention Type: DRUG

Other Intervention Names

XL184

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.

• Minimum Eligible Age: 20 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Takeda

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Medical Director

Role: STUDY_DIRECTOR

Takeda

Locations

Nagoya University Hospital

Nagoya, Aichi-ken, Japan

Hokkaido University Hospital

Sapporo, Hokkaido, Japan

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

Keio University Hospital

Shinjuku-ku, Tokyo, Japan

Tokyo Women's Medical University Hospital

Shinjuku-ku, Tokyo, Japan

Kyushu University Hospital

Fukuoka, , Japan

Niigata University Medical and Dental Hospital

Niigata, , Japan

Okayama University Hospital

Okayama, , Japan

Osaka City University Hospital

Osaka, , Japan

Osaka International Cancer Institute

Osaka, , Japan

Tokushima University Hospital

Tokushima, , Japan

Yamagata University Hospital

Yamagata, , Japan

Countries

Japan

References

Nakaigawa N, Tomita Y, Tamada S, Tatsugami K, Osawa T, Oya M, Kanayama H, Miura Y, Sassa N, Nishimura K, Nozawa M, Masumori N, Miyoshi Y, Kuroda S, Kimura A. Final efficacy and safety results and biomarker analysis of a phase 2 study of cabozantinib in Japanese patients with advanced renal cell carcinoma. Int J Clin Oncol. 2023 Mar;28(3):416-426. doi: 10.1007/s10147-022-02283-w. Epub 2023 Jan 3.

Reference Type: DERIVED

PMID: 36595123 (View on PubMed)

Tomita Y, Tatsugami K, Nakaigawa N, Osawa T, Oya M, Kanayama H, Nakayama Kondoh C, Sassa N, Nishimura K, Nozawa M, Masumori N, Miyoshi Y, Kuroda S, Tanaka S, Kimura A, Tamada S. Cabozantinib in advanced renal cell carcinoma: A phase II, open-label, single-arm study of Japanese patients. Int J Urol. 2020 Nov;27(11):952-959. doi: 10.1111/iju.14329. Epub 2020 Aug 12.

Reference Type: DERIVED

PMID: 32789967 (View on PubMed)

Provided Documents

Document Type: Study Protocol

View Document

Document Type: Statistical Analysis Plan

View Document

Other Identifiers

U1111-1201-4230

Identifier Type: OTHER

Identifier Source: secondary_id

JapicCTI-173763

Identifier Type: REGISTRY

Identifier Source: secondary_id

Cabozantinib-2001

Identifier Type: -

Identifier Source: org_study_id