Healthcare Cost and Resource Utilization Related to Metastatic Renal Cell Carcinoma Treatment With Intravenous and Oral Agents

Renal Cell Carcinoma Clinical Trial

Official title:

A Healthcare Cost and Resource Utilization Analysis of Intravenous and Oral Agents in the Treatment of Metastatic Renal Cell Carcinoma

Clinical Trial Details — Status: Withdrawn

Administrative data

• NCT number: NCT02928263
• Other study ID #: CA209-780
• Status: Withdrawn
• Phase: N/A
• First received: October 7, 2016
• Last updated: July 13, 2017
• Start date: February 28, 2017
• Est. completion date: May 31, 2017

Study information

• Verified date: July 2017
• Source: Bristol-Myers Squibb
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial Summary

A retrospective study to evaluate healthcare cost and resource utilization for patients with metastatic renal cell carcinoma who have been treated with IV or oral agents

Recruitment information / eligibility

• Status: Withdrawn
• Enrollment: 0
• Est. completion date: May 31, 2017
• Est. primary completion date: May 31, 2017
• Accepts healthy volunteers: No
• Gender: All
• Age group: N/A and older

Eligibility

Inclusion Criteria:

• Diagnosis with metastatic renal cell carcinoma

• Prescription/administration of one of the IV or oral agents examined in the study

Exclusion Criteria:

• Patients with other primary cancer diagnosis before RCC diagnosis

• Patients with pregnancy or HIV/AIDS

Related Conditions & MeSH terms

• Carcinoma
• Carcinoma, Renal Cell
• Renal Cell Carcinoma

Intervention

Other:
• Non-Interventional
Other

Locations

Country	Name	City	State
United States	Bristol-Myers Squibb	Princeton	New Jersey

Sponsors (1)

Lead Sponsor	Collaborator
Bristol-Myers Squibb

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Distribution of Healthcare costs for patients treated with oral drugs used in the first-line treatment of Metastatic renal cell carcinoma (mRCC)	All-cause healthcare costs will be calculated in the first-line oral cohort as per-patient-per-month (PPPM) costs.	Up to 63 months
Primary	Composite of Resource Utilization for patients treated with oral drugs used in the first-line treatment of mRCC	Total numbers and rates of inpatient, outpatient, and emergency room visits per patient will be calculated.	Up to 63 months
Primary	Distribution of Healthcare costs for patients treated with IV drugs used in the first-line treatment of mRCC	All-cause healthcare costs will be calculated in the first-line IV cohort as per-patient-per-month (PPPM) costs.	Up to 63 months
Primary	Composite of Resource Utilization for patients treated with IV drugs used in the first-line treatment of mRCC	Total numbers and rates of inpatient, outpatient, and emergency room visits per patient will be calculated.	Up to 63 months
Secondary	Medication Possession Ratio (MPR) for patients treated with oral drugs used in the first-line treatment of mRCC	MPR will be calculated for each index drug as the ratio of the sum of the total number of days' supply to the total number of days in the follow-up period.	Up to 63 months
Secondary	Medication Possession Ratio (MPR) for patients treated with IV drugs used in the first-line treatment of mRCC	MPR will be calculated for each index drug as the ratio of the sum of the total number of days' supply to the total number of days in the follow-up period.	Up to 63 months

External Links

•   BMS Clinical Trial Information
•   FDA Safety Alerts and Recalls
•   Investigator Inquiry Form