Clinical Outcomes for Patients With Renal Cell Carcinoma Who Received First-Line Sunitinib

NCT04076787 | Completed Results

• 1 other identifier: A6181229
• Study Type: observational
• Target: 1,769
• Locations: 1 country
• Sites: 1

Brief Summary

This is a retrospective, longitudinal cohort study that assessed clinical outcomes of patients with metastatic renal cell carcinoma (mRCC) who received sunitinib as first-line treatment.

Conditions

Metastatic Renal Cell Carcinoma

Keywords

Vascular endothelial growth factor (VEGF); Sunitinib

Outcome Measures

Primary Outcomes (6)

• Overall Survival

  Overall survival was defined as the time between index date and death due to any cause or end of data availability. The index date was defined as the date of initiation of first-line sunitinib therapy.

  60 months

• Time to First-Line Sunitinib Treatment Discontinuation

  Time to treatment discontinuation was defined as the time between index date and either discontinuation of first-line sunitinib therapy due to any reason including disease progression, death, toxicity, both disease progression and toxicity, other or end of data availability. The index date was defined as the date of initiation of first-line sunitinib therapy.

  60 months

• Number of Participants Who Discontinued First-Line Sunitinib Treatment

  In this outcome measure, participants who discontinued treatment due to any reason like disease progression, death, toxicity, both disease progression and toxicity, other or end of data availability are reported.

  60 months

• Percentage of Participants With Objective Response (OR)

  Percentage of participants with OR based assessment of confirmed complete response (CR) or confirmed partial response (PR) according to Response Evaluation Criteria in Solid Tumors (RECIST) version 1.1. Confirmed responses are those that persist on repeat imaging study at least 4 weeks after initial documentation of response. CR are defined as the disappearance of all lesions (target and/or non target). Any pathological lymph nodes (whether target or non-target) must have reduction in short axis to \<10 millimeter. PR are those with at least 30 percent (%) decrease in the sum of diameters of the target lesions taking as a reference the baseline sum diameters.

  60 months

• Percentage of Participants With Progressive Disease

  Progressive disease (PD) was defined as an increase in visible disease. According to Response Evaluation Criteria in Solid Tumors (RECIST 1.1) progressive disease: - at least a 20% increase in the sum of diameters of target lesions taking as reference the smallest sum on the study. This includes the baseline sum if that is the smallest on study. In addition to the relative increase of 20%, the sum must also demonstrate an absolute increase of at least 5 mm. The appearance of one or more new lesions is also considered progression.

  60 months

• Percentage of Participants With Stable Disease

  Stable disease was defined as no change in size of visible disease. According to Response Evaluation Criteria in Solid Tumors (RECIST 1.1), stable disease neither sufficient shrinkage to qualify for PR nor sufficient increase to qualify for PD, taking as reference the smallest sum diameters while on study. Progressive disease: - at least a 20% increase in the sum of diameters of target lesions taking as reference the smallest sum on the study. PR are those with at least 30 percent (%) decrease in the sum of diameters of the target lesions taking as a reference the baseline sum diameters.

  60 months

Study Arms (3)

Favorable IMDC risk group

The cohort of mRCC patients receiving sunitinib as first-line treatment and classified as favorable IMDC risk group for having 0 individual risk factor

Drug: Sunitinib

Intermediate IMDC risk group

The cohort of mRCC patients receiving sunitinib as first-line treatment and classified as intermediate IMDC risk group for having 1 or 2 individual risk factors

Drug: Sunitinib

Poor IMDC risk group

The cohort of mRCC patients receiving sunitinib as first-line treatment and classified as poor IMDC risk group for having 3 or more individual risk factors

Drug: Sunitinib

Interventions

Sunitinib DRUG

patients who received sunitinib as first line therapy for mRCC

Favorable IMDC risk group; Intermediate IMDC risk group; Poor IMDC risk group

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Patients diagnosed with clear cell mRCC at age 18 or older who initiated sunitinib as first-line treatment between 2010 and 2018

You may qualify if:

• Diagnosed with mRCC
• Initiated treatment post mRCC diagnosis and received sunitinib as first-line therapy
• Age 18 years or over at the time of mRCC diagnosis
• Actively treated at an IMDC clinical center

You may not qualify if:

• Initiated first line sunitinib treatment before 2010
• Had non-clear cell mRCC

Sponsors & Collaborators

• Pfizer: lead
• International Metastatic Renal Cell Carcinoma Database Consortium (IMDC): collaborator
• Analysis Group, Inc.: collaborator

Study Sites (1)

University of Calgary

Calgary, Alberta, P2N4N2, Canada

Location

Related Links

• To obtain contact information for a study center near you, click here.

MeSH Terms

Conditions

Carcinoma, Renal Cell

Interventions

Sunitinib

Condition Hierarchy (Ancestors)

Adenocarcinoma; Carcinoma; Neoplasms, Glandular and Epithelial; Neoplasms by Histologic Type; Neoplasms; Kidney Neoplasms; Urologic Neoplasms; Urogenital Neoplasms; Neoplasms by Site; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Kidney Diseases; Urologic Diseases; Male Urogenital Diseases

Intervention Hierarchy (Ancestors)

Pyrroles; Azoles; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds; Indoles; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring

Results Point of Contact

• Title: Pfizer ClinicalTrials.gov Call Center
• Organization: Pfizer Inc.

ClinicalTrials.gov_Inquiries@pfizer.com

1-800-718-1021

Study Officials

• Pfizer CT.gov Call Center

  Pfizer

  STUDY DIRECTOR

Publication Agreements

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

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: RETROSPECTIVE
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: August 30, 2019
• First Posted: September 3, 2019
• Study Start: September 1, 2018
• Primary Completion: September 2, 2018
• Study Completion: September 2, 2018
• Last Updated: April 6, 2023
• Results First Posted: October 10, 2019

Record last verified: 2021-02

Data Sharing

• IPD Sharing: Will not share

Locations

CA (1)