Survey of Cabozantinib Used To Treat People With Renal Cell Carcinoma

JRCT ID: jRCT2031210003

Registered date:01/04/2021

Basic Information

• Recruitment status: Complete
• Health condition(s) or Problem(s) studied: Renal cell carcinoma
• Date of first enrollment: 29/03/2021
• Target sample size: 388
• Study type: Observational
• Intervention(s): Cabozantinib 60 mg: Cabozantinib 60 milligrams (mg) tablet, orally, once daily for up to 26 weeks. Participants received interventions as part of routine medical care.

Outcome(s)

Primary Outcome

1.Number of Participants with Adverse Events Related to Hepatic Failure, Hepatic Dysfunction, and Pancreatitis
Timeframe: Up to 26 weeks
An adverse event (AE) is any untoward or undesirable medical occurrence in a participant linked in time with the use of a pharmaceutical/ medicinal product. They are not limited to the events with clear causal relationship with treatment with concerned drug. An adverse event can therefore be any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease temporally associated with the use of a medicinal product, whether or not related to the medicinal product.
2.Number of Participants with Serious Adverse Events
Timeframe: Up to 26 weeks
A serious AE is any untoward medical occurrence or effect that at any dose results in death, is life-threatening, requires inpatient hospitalization or prolongation of existing hospitalization, results in persistent or significant disability / incapacity, is a congenital anomaly / birth defect or is medically important due to other reasons than the above mentioned criteria.
3.Number of Participants with Adverse Events Leading to Permanent Treatment Discontinuation with Cabozantinib Tablets
Timeframe: Up to 26 weeks
4.Number of Participants with Grade 3 or higher Adverse Events
Timeframe: Up to 26 weeks
Severity grade is defined by the National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE) Version 5.0.

Secondary Outcome

1.Percentage of Participants Who Achieve or Maintain Any Best Response Category
Timeframe: Up to 26 weeks
Best response will be assessed with reference to the excerpts from Response Evaluation Criteria in Solid Tumors (RECIST 1.1). Best response is defined as the level of best response in assessment with complete response (CR), partial response (PR), progressive disease (PD), stable disease (SD) and not evaluable (NE) during the observational period .

Key inclusion & exclusion criteria

• Age minimum: Not applicable
• Age maximum: Not applicable
• Gender: Both
• Include criteria: Patients with radically unresectable or metastatic renal cell carcinoma who do not meet the following exclusion criterion are eligible.
• Exclude criteria: A patient who has a history of hypersensitivity to any component of cabozantinib

Related Information

• Primary Sponsor: Contact for Clinical Trial Information
• Secondary ID(s): NCT04804813