A Study to go Back Into Records and Observe How People With Metastatic Renal Cell Carcinoma (mRCC) Who Received a Medicine Called Sunitinib Responded to This Medicine.

NCT05745142 | Completed Results

• 1 other identifier: A6181235
• Study Type: observational
• Target: 376
• Locations: 1 country
• Sites: 1

Brief Summary

The purpose of this study is to understand how patients with mRCC respond to the study medicine (called sunitinib) when they receive it as the first line of treatment after finding out the cause for the disease. This study will look into how different and how well groups of people with high chances of developing the disease respond to the study medicine. All data for this study will be anonymously extracted from data already entered in RCC Registry which is owned by Turkish Oncology Group Association (TOGD). This study will pull out records from the Registry between 01-Mar-2019 and 30-Oct-2022 that belongs to people:

• who are Turkish citizens
• who are older than 18 years
• who were found out to have mRCC
• who received sunitinib as the first line treatment after finding out the cause for the disease This study will look at the responses, experiences and how long the patients use the study medicine sunitinib.

Conditions

Carcinoma, Renal Cell; Clear-cell Metastatic Renal Cell Carcinoma

Keywords

mRCC; Metastatic Renal Cell Carcinoma; Clear-cell metastatic renal cell carcinoma

Outcome Measures

Primary Outcomes (4)

• Objective Response Rate (ORR) According to Disease Risk Group in IMDC

  ORR: percentage of participants with partial response (PR) and complete response (CR). As per response evaluation criteria in solid tumors (RECIST)1.1 criteria: CR = disappearance of all target lesions. Any pathological lymph nodes (whether target or non-target) must have reduction in short axis to \<10 mm. Disappearance of all non-target lesions and normalization of tumor marker level. All lymph nodes must be non-pathological in size (\<10 mm short axis); PR = at least 30% decrease in sum of diameters of target lesions taking as reference baseline sum diameters. IMDC assessed as favorable (0), intermediate (1-2) or poor (\>=3) based on number of criteria present (KPS \<80%; time from diagnosis to start of systemic therapy \<1 year; corrected serum calcium \[Ca\]; neutrophils and platelets \>ULN; hemoglobin \[hg\] \<LLN).

  From initiation of sunitinib treatment (retrospective data) till PR and CR or death or progression (up to 30-Oct-2022, cut-off for data registry); approximate follow-up duration of 73 months [from data extracted from registry database]

• Response Rates According to Disease Risk Group in IMDC

  RECIST1.1- CR: disappearance of all lesions \& normalization of tumor marker level. Any pathological lymph nodes must have reduction in short axis to \<10 mm. All lymph nodes must be non-pathological in size (\<10 mm short axis); PR: at least 30% decrease in sum of diameters of target lesions taking as reference baseline sum diameters; progressive disease (PD): at least 20% increase in sum of longest dimensions of target lesions, reference to the smallest sum of the longest dimensions recorded since treatment started, or appearance of 1 or more new lesions or increase of at least 5 mm in addition to the relative increase of 20%; stable disease (SD): neither shrinkage for CR/PR nor increase for PD taking as reference smallest sum of longest diameters since treatment start. IMDC: favorable (0), intermediate (1-2) or poor (\>=3) based on number of criteria present (KPS \<80%; time from diagnosis to start of systemic therapy \<1 year; corrected serum Ca\]; neutrophils \& platelets \>ULN; hg \<LLN).

  From initiation of sunitinib treatment (retrospective data) till PR/ CR/ SD/ death or progression (up to 30-Oct-2022, cut-off for data registry); approximate follow-up duration of 73 months [from data extracted from registry database]

• ORR According to Disease Risk Group in MSKCC

  ORR: percentage of participants with PR and CR. As per RECIST 1.1 criteria: CR = disappearance of all target lesions. Any pathological lymph nodes (whether target or non-target) must have reduction in short axis to \<10 mm. Disappearance of all non-target lesions and normalization of tumor marker level. All lymph nodes must be non-pathological in size (\<10 mm short axis); PR = at least 30% decrease in sum of diameters of target lesions taking as reference baseline sum diameters. MSKCC assessed as favorable (0), intermediate (1-2) or poor (\>=3) based on number of criteria present \[KPS \<80%, time from diagnosis to start of systemic therapy \<12 months, lactate dehydrogenase \>1.5\*ULN, hemoglobin \<LLN, serum calcium \>10 mg/dL\].

  From initiation of sunitinib treatment (retrospective data) till PR and CR or death or progression (up to 30-Oct-2022, cut-off for data registry); approximate follow-up duration of 73 months [from data extracted from registry database]

• Response Rates According to Disease Risk Group in MSKCC

  RECIST1.1- CR: disappearance of all lesions and normalization of tumor marker level. Any pathological lymph nodes must have reduction in short axis to \<10 mm. All lymph nodes must be non-pathological in size (\<10 mm short axis); PR: at least 30% decrease in sum of diameters of target lesions taking as reference baseline sum diameters; PD: at least 20% increase in sum of longest dimensions of target lesions, reference to the smallest sum of the longest dimensions recorded since treatment started, or the appearance of 1 or more new lesions or increase of at least 5 mm in addition to the relative increase of 20%; SD: neither shrinkage for CR/PR nor increase for PD taking as reference smallest sum of longest diameters since treatment start. MSKCC assessed as favourable (0), intermediate (1-2) or poor (\>=3) based on number of criteria present \[KPS \<80%, time from diagnosis to start of systemic therapy \<12 months, lactate dehydrogenase \>1.5\*ULN, hemoglobin \<LLN, serum calcium \>10 mg/dL\].

  From initiation of sunitinib treatment (retrospective data) till PR/ CR/ SD/ death or progression (up to 30-Oct-2022, cut-off for data registry); approximate follow-up duration of 73 months [from data extracted from registry database]

Secondary Outcomes (4)

• Overall Survival (OS) Rate According to Disease Risk Group in IMDC

  From initiation of sunitinib treatment (retrospective data) till death or censored date (up to 30-Oct-2022, cut-off for data registry); approximate follow-up duration of 73 months [from data extracted from registry database]

• Progression-Free Survival (PFS) According to Disease Risk Group in IMDC

  From initiation of sunitinib treatment (retrospective data) till progression end of treatment date or date of death (up to 30-Oct-2022, cut-off for data registry); approximate follow-up duration of 73 months [from data extracted from registry database]

• OS According to Disease Risk Group in MSKCC

  From initiation of sunitinib treatment (retrospective data) till death or censored date (up to 30-Oct-2022, cut-off for data registry); approximate follow-up duration of 73 months [from data extracted from registry database]

• PFS According to Disease Risk Group in MSKCC

  From initiation of sunitinib treatment (retrospective data) till progression end of treatment date or date of death (up to 30-Oct-2022, cut-off for data registry); approximate follow-up duration of 73 months [from data extracted from registry database]

Study Arms (1)

metastatic Renal Cell Carcinoma patients

metastatic Renal Cell Carcinoma patients with clear cell histology.

Drug: Sunitinib

Interventions

Sunitinib DRUG

as provided in real world practice

metastatic Renal Cell Carcinoma patients

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

RCC Registry will be screened for all patients who meets all inclusion criteria and who doesn't meet the exclusion criterion defined in the study protocol and who were treated with Sunitinib in first-line therapy for mRCC and were registered to the database between 2019 and 2022.

You may qualify if:

• Being a Turkish citizen.
• Being older than 18 years-old.
• Being clinically diagnosed with mRCC and treated.
• Being treated with Sunitinib in first line

You may not qualify if:

• Patients whose treatment was initiated but excluded from follow-up for any reason.

Sponsors & Collaborators

• Pfizer: lead

Study Sites (1)

Pfizer

Istanbul, 34394, Turkey (Türkiye)

Location

Related Links

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

MeSH Terms

Conditions

Carcinoma, Renal Cell; Clear-cell metastatic renal cell carcinoma

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 Inc.
• Organization: Pfizer ClinicalTrials.gov Call Center

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: January 26, 2023
• First Posted: February 27, 2023
• Study Start: February 23, 2023
• Primary Completion: February 23, 2023
• Study Completion: February 23, 2023
• Last Updated: August 5, 2024
• Results First Posted: August 5, 2024

Record last verified: 2024-02

Data Sharing

• IPD Sharing: Will not share

Locations

TU (1)