Cabozantinib ePRO study

JRCT ID: jRCTs011210055

Registered date:06/12/2021

Basic Information

• Recruitment status: Recruiting
• Health condition(s) or Problem(s) studied: Renal cell carcinoma
• Date of first enrollment: 18/01/2022
• Target sample size: 105
• Study type: Interventional
• Intervention(s): randomaization

Outcome(s)

Primary Outcome

Deterioration rate of the Functional Assessment of Cancer Therapy (FACT) -Kidney Cancer Symptom Index (FKSI -19) during the period until Week 24 or discontinuation
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.

Secondary Outcome

-Changes in FKSI-19
-Changes in Medical outcome study short form-8 (SF-8)
-Change in EQ-5D-5L
-Changes in instrumental activities of daily living (IADL)
-Progression free survival (PFS) at 24 weeks as determined by the investigator or subinvestigator according to RECIST1.1
-Dose adjustment (Interruption, dose reduction, discontinuation) rate and duration during the study
-relative dose intensity (RDI)
-Frequency of therapeutic interventions for TEAEs outside of scheduled visits
-Safety
-Percentage of Participants with Treatment-Emergent Adverse Events (TEAE) Following Cabozantinib Treatment
-Proportion of subjects with Grade 3 or higher TEAEs.
-Proportion of subjects with serious TEAEs.
-Percentage of study subjects who discontinued cabozantinib due to a TEAE
-Percentage of participants with TEAEs leading to dose modification (dose reduction or interruption) of cabozantinib
-Time to first awareness by the investigator of the occurrence of a TEAE
-Time to start handling TEAEs
-Questionnaire survey of investigators and study subjects (ePRO/paper-PRO monitoring group only)
-ePRO/paper-PRO adherence rates (ePRO/paper-PRO monitoring arm only)

Key inclusion & exclusion criteria

• Age minimum: >= 18age old
• Age maximum: Not applicable
• Gender: Both

Include 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

Exclude 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

Related Information

• Primary Sponsor: Osawa Takahiro
• Source(s) of Monetary Support: Takeda Pharmaceutical Company Limited