Cabozantinib ePRO study

Phase 2

• Conditions: Renal cell carcinoma

• Registration Number: JPRN-jRCTs011210055
• Lead Sponsor: Osawa Takahiro

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2021-12-06
• Last Update Posted: 27 May 2024

Recruitment & Eligibility

• Status: ot Recruiting
• Sex: All
• Target Recruitment: 105

Inclusion Criteria

1.Patients aged 18 years or older at the time of informed consent (regardless of gender)
2.Patients with clinically or histologically confirmed renal cell carcinoma who are deemed eligible for cabozantinib according to the package insert.
3.Patients who are receiving treatment including immune checkpoint inhibitors (Pembrolizumab,
ipilimumab, nivolumab, avelumab, etc.) for renal cell carcinoma.
4.Patients who are scheduled to start treatment with cabozantinib monotherapy for unresectable or metastatic renal cell carcinoma (treatment start dose:60mg/day)
5.Karnofsky Performance Status (KPS) score >= 60%
6.Patients capable of handling electronic devices (may require some assistance)
7.CT or MRI including the chest and abdomen has been assessed or is expected to be assessed within 28 days prior to initiation of cabozantinib treatment (Imaging is recommended as much as possible for both CT and MRI.)
8.Patients expected to survive for at least 6 months at the time of informed consent
9.In the opinion of the investigator or sub-investigator, the subject is capable of understanding and complying with protocol requirements.
10.Patients who can sign and date a written informed consent form prior to enrollment in the study

Exclusion Criteria

1.Patients with treatment-emergent adverse events that have not resolved to baseline or Grade <= 1 according to CTCAE version 5.0. unless clinically insignificant or stable on supportive care.
2.Pregnant or breastfeeding women, or women who are unable to prevent pregnancy during the study and for 4 months after the last dose.
3.Patients unable to swallow tablets
4.Patients previously treated with cabozantinib
5.History of allergy or hypersensitivity to any of the ingredients of cabozantinib.
6.Current or planned participation in another clinical study or a clinical study involving an intervention.
7.Other patients considered ineligible for the study by the investigator or sub-investigator

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Deterioration rate of the Functional Assessment of Cancer Therapy (FACT) -Kidney Cancer Symptom Index (FKSI -19) during the period until Week 24 or discontinuation<br>Deterioration rate of FKSI: A decrease of >= 5 points from baseline is defined as deterioration, and the percentage of study subjects whose FKSI-19 assessment after the start of cabozantinib was reduced by at least one time from baseline by at least 5 points.