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

NCT03339219 | Completed Phase 2 Results

• 3 other identifiers: Cabozantinib-2001U1111-1201-4230JapicCTI-173763
• Study Type: interventional
• Target: 35
• Locations: 1 country
• Sites: 19

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.

Conditions

Advanced Renal Cell Carcinoma

Keywords

Drug Therapy

Outcome Measures

Primary Outcomes (1)

• 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.

  From first dose of study drug up to first documentation of CR or PR (up to 2.5 years)

Secondary Outcomes (10)

• Clinical Benefit Rate (CBR)

  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)

  From first dose of study drug up to disease progression or death (up to 2.5 years)

• Overall Survival (OS)

  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)

  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

  From first dose up to 30 days after the last dose of the study drug (up to 2.6 years)

Study Arms (1)

Cabozantinib 60 mg

EXPERIMENTAL

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.

Drug: Cabozantinib

Interventions

Cabozantinib DRUG

Cabozantinib tablets

Also known as: XL184

Cabozantinib 60 mg

Eligibility Criteria

• Age: 20 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Takeda: lead

Study Sites (19)

Nagoya University Hospital

Nagoya, Aichi-ken, Japan

Location

Hokkaido University Hospital

Sapporo, Hokkaido, Japan

Location

Sapporo Medical University Hospital

Sapporo, Hokkaido, Japan

Location

Kobe University Hospital

Kobe, Hyōgo, Japan

Location

Yokohama City University Hospital

Yokohama, Kanagawa, Japan

Location

Yokohama City University Medical Center

Yokohama, Kanagawa, Japan

Location

Kindai University Hospital

Sayama, Osaka, Japan

Location

Osaka University Hospital

Suita, Osaka, Japan

Location

Nippon Medcal School Hospital

Bunkyo-ku, Tokyo, Japan

Location

Toranomon Hospital

Minato-ku, Tokyo, Japan

Location

Keio University Hospital

Shinjuku-ku, Tokyo, Japan

Location

Tokyo Women's Medical University Hospital

Shinjuku-ku, Tokyo, Japan

Location

Kyushu University Hospital

Fukuoka, Japan

Location

Niigata University Medical and Dental Hospital

Niigata, Japan

Location

Okayama University Hospital

Okayama, Japan

Location

Osaka City University Hospital

Osaka, Japan

Location

Osaka International Cancer Institute

Osaka, Japan

Location

Tokushima University Hospital

Tokushima, Japan

Location

Yamagata University Hospital

Yamagata, Japan

Location

Related Publications (2)

• 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.

  PMID: 36595123 DERIVED

• 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.

  PMID: 32789967 DERIVED

MeSH Terms

Interventions

cabozantinib

Results Point of Contact

• Title: Study Director
• Organization: Takeda

TrialDisclosures@takeda.com

+1-877-825-3327

Study Officials

• Medical Director

  Takeda

  STUDY DIRECTOR

Publication Agreements

• PI is Sponsor Employee: No
• Restriction Type: OTHER
• Restrictive Agreement: Yes

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: November 8, 2017
• First Posted: November 13, 2017
• Study Start: December 13, 2017
• Primary Completion: August 25, 2020
• Study Completion: August 25, 2020
• Last Updated: September 20, 2021
• Results First Posted: September 20, 2021

Record last verified: 2021-08

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP, ICF, CSR
• Access Criteria: IPD from eligible studies will be shared with qualified researchers according to the criteria and process described on https://vivli.org/ourmember/takeda/. For approved requests, the researchers will be provided access to anonymized data (to respect patient privacy in line with applicable laws and regulations) and with information necessary to address the research objectives under the terms of a data sharing agreement.

Locations

JP (19)