- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT04175262
Clinical Outcomes For Patients With Metastatic Renal Cell Carcinoma (mRCC) Who Received Sunitinib After 1st Line Immune-oncology (IO) Treatments
April 28, 2023 updated by: Pfizer
Clinical Effectiveness of Second-Line Sunitinib Following Immune-oncologic (IO) Therapy in Patients With Metastatic Renal Cell Carcinoma in the International Metastatic Renal Cell Carcinoma Database (IMDC)
The study aims to assess clinical outcomes in mRCC patients treated with sunitinib in second-line following IO therapy in real world clinical practices.
Study Overview
Status
Completed
Conditions
Intervention / Treatment
Study Type
Observational
Enrollment (Actual)
102
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
-
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Alberta
-
Calgary, Alberta, Canada, p2n 4n2
- University of Calgary
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-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
- Adult
- Older Adult
Accepts Healthy Volunteers
No
Sampling Method
Non-Probability Sample
Study Population
patients with diagnosis of mRCC who initiated sunitinib as 2nd line treatment
Description
Inclusion Criteria:
Patients must meet all of the following inclusion criteria to be eligible for inclusion in the study:
- Diagnosed with mRCC
- Received IO therapy as 1L therapy
- Received sunitinib as 2L therapy
- Age 18 years or over at the time of mRCC diagnosis
- Actively treated at an IMDC clinical center (to avoid incomplete data)
Exclusion Criteria:
None
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
Cohorts and Interventions
Group / Cohort |
Intervention / Treatment |
---|---|
Patients with mRCC
Patients diagnosed with metastatic RCC receiving first line (1L) combination of IOs therapies followed by Sunitinib as a second line (2L) treatment
|
Patients to receive sunitinib as second line therapy for mRCC
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Overall Survival (OS) After Initiation of Second Line Sunitinib Therapy
Time Frame: From the date of initiation of second line sunitinib to the date of death or censored date, up to a maximum of approximately 5.5 years (from the data collected and observed retrospectively for approximately 4 months)
|
Overall survival was defined as the time (in months) from second line sunitinib initiation to death.
Participants were censored at their date of last follow-up.
Kaplan-Meier method was used for analysis.
|
From the date of initiation of second line sunitinib to the date of death or censored date, up to a maximum of approximately 5.5 years (from the data collected and observed retrospectively for approximately 4 months)
|
Time to Treatment Discontinuation (TTD) of Second Line Sunitinib Therapy
Time Frame: From the date of initiation of second line sunitinib to discontinuation or censored date, up to a maximum of approximately 5.5 years (from the data collected and observed retrospectively for approximately 4 months)
|
TTD was defined as the time (in months) between initiation of second line sunitinib therapy and discontinuation of therapy for any reason including progression, death, and toxicity.
Participants were censored at their date of last follow-up.
As per response evaluation criteria in solid tumors (RECIST) 1.1 criteria: disease progression was at least a 20% increase in sum of diameters of target lesions, taking as a reference smallest sum on treatment, the sum must also demonstrate an absolute increase of at least 5 millimeter (mm), or the appearance of at least 1 new lesion.
Unequivocal progression of existing non-target lesions.
Kaplan-Meier method was used for analysis.
|
From the date of initiation of second line sunitinib to discontinuation or censored date, up to a maximum of approximately 5.5 years (from the data collected and observed retrospectively for approximately 4 months)
|
Time to Treatment Discontinuation (TTD) of First Line Immune-Oncologic Therapy
Time Frame: From the initiation of immune-oncologic therapy to discontinuation of immune-oncologic therapy (approximately up to 2 years)
|
TTD was defined as the time (in months) between initiation of first line Immune-Oncologic therapy and discontinuation of therapy for any reason including progression, death, and toxicity.
Participants were censored at their date of last follow-up.
As per RECIST 1.1 criteria: disease progression was at least a 20% increase in sum of diameters of target lesions, taking as a reference smallest sum on treatment, the sum must also demonstrate an absolute increase of at least 5 mm, or the appearance of at least 1 new lesion.
Unequivocal progression of existing non-target lesions.
Kaplan-Meier method was used for analysis.
|
From the initiation of immune-oncologic therapy to discontinuation of immune-oncologic therapy (approximately up to 2 years)
|
Number of Participants Classified According to Reasons for Second-Line Sunitinib Treatment Discontinuation
Time Frame: From the date of initiation of second line sunitinib to discontinuation or censored date, up to a maximum of approximately 5.5 years (from the data collected and observed retrospectively for approximately 4 months)
|
Reasons for treatment discontinuation included disease progression, death, toxicity and other reasons including urosepsis, nausea, vomiting, diarrhea, comorbidity, and other unspecified.
As per RECIST v1.1.
criteria, disease progression was at least a 20% increase in sum of diameters of target lesions, taking as a reference smallest sum on treatment, the sum must also demonstrate an absolute increase of at least 5 mm, or the appearance of at least 1 new lesion.
Unequivocal progression of existing non-target lesions.
|
From the date of initiation of second line sunitinib to discontinuation or censored date, up to a maximum of approximately 5.5 years (from the data collected and observed retrospectively for approximately 4 months)
|
Objective Response Rate (ORR) After Initiation of Second Line Sunitinib Therapy
Time Frame: From the date of initiation of second line sunitinib to the date of PR and CR or censored date, up to a maximum of approximately 5.5 years (from the data collected and observed retrospectively for approximately 4 months)
|
The objective response rate was defined as the percentage of participants with partial response (PR) and complete response (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 normalisation of tumour 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.
|
From the date of initiation of second line sunitinib to the date of PR and CR or censored date, up to a maximum of approximately 5.5 years (from the data collected and observed retrospectively for approximately 4 months)
|
Percentage of Participants With Progressive Disease (PD) After Initiation of Second Line Sunitinib Therapy
Time Frame: From the date of initiation of second line sunitinib to occurrence of disease progression, up to a maximum of approximately 5.5 years (from the data collected and observed retrospectively for approximately 4 months)
|
Progressive disease (PD) was defined as an increase in visible disease.
According to RECIST 1.1; PD = 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 also demonstrated an absolute increase of at least 5 mm or the appearance of at least 1 new lesion.
Unequivocal progression of existing non-target lesions.
|
From the date of initiation of second line sunitinib to occurrence of disease progression, up to a maximum of approximately 5.5 years (from the data collected and observed retrospectively for approximately 4 months)
|
Percentage of Participants With Stable Disease (SD) After Initiation of Second Line Sunitinib Therapy
Time Frame: From the date of initiation of second line sunitinib to the date stable disease or censored date, up to a maximum of approximately 5.5 years (from the data collected and observed retrospectively for approximately 4 months)
|
Stable disease was defined as no change in size of visible disease.
According to RECIST 1.1, stable disease: neither sufficient shrinkage to qualify for PR nor sufficient increase to qualify for progressive disease , taking as reference the smallest sum diameters while on study; PD = 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 also demonstrated an absolute increase of at least 5 mm or the appearance of at least 1 new lesion.
Unequivocal progression of existing non-target lesions.
PR = at least 30% decrease in sum of diameters of target lesions taking as reference baseline sum diameters.
|
From the date of initiation of second line sunitinib to the date stable disease or censored date, up to a maximum of approximately 5.5 years (from the data collected and observed retrospectively for approximately 4 months)
|
Time From First Line Immune-Oncologic Therapy Discontinuation to Initiation of Second Line Sunitinib Therapy
Time Frame: From the discontinuation of immune-oncologic therapy to the initiation of sunitinib therapy (approximately up to 2 years)
|
From the discontinuation of immune-oncologic therapy to the initiation of sunitinib therapy (approximately up to 2 years)
|
|
Number of Participants Classified According to Reasons for First-Line Immune-Oncologic Treatment Discontinuation
Time Frame: From the date of initiation of first line Immune-Oncologic to discontinuation or follow-up (approximately up to 2 years)
|
Reasons for treatment discontinuation included disease progression, toxicity and other reasons including itchiness, mouth dryness, comorbidity, and other unspecified.
As per RECIST 1.1 criteria: disease progression was at least a 20% increase in sum of diameters of target lesions, taking as a reference smallest sum on treatment, the sum must also demonstrate an absolute increase of at least 5 mm, or the appearance of at least 1 new lesion.
Unequivocal progression of existing non-target lesions.
|
From the date of initiation of first line Immune-Oncologic to discontinuation or follow-up (approximately up to 2 years)
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Publications and helpful links
The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (Actual)
October 31, 2019
Primary Completion (Actual)
March 9, 2020
Study Completion (Actual)
March 9, 2020
Study Registration Dates
First Submitted
November 21, 2019
First Submitted That Met QC Criteria
November 22, 2019
First Posted (Actual)
November 25, 2019
Study Record Updates
Last Update Posted (Actual)
May 3, 2023
Last Update Submitted That Met QC Criteria
April 28, 2023
Last Verified
March 1, 2021
More Information
Terms related to this study
Additional Relevant MeSH Terms
- Neoplasms by Histologic Type
- Neoplasms
- Urologic Neoplasms
- Urogenital Neoplasms
- Neoplasms by Site
- Kidney Diseases
- Urologic Diseases
- Adenocarcinoma
- Neoplasms, Glandular and Epithelial
- Kidney Neoplasms
- Carcinoma, Renal Cell
- Carcinoma
- Physiological Effects of Drugs
- Molecular Mechanisms of Pharmacological Action
- Enzyme Inhibitors
- Antineoplastic Agents
- Angiogenesis Inhibitors
- Angiogenesis Modulating Agents
- Growth Substances
- Growth Inhibitors
- Protein Kinase Inhibitors
- Sunitinib
Other Study ID Numbers
- A6181233
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
NO
IPD Plan Description
Pfizer will provide access to individual de-identified participant data and related study documents (e.g.
protocol, Statistical Analysis Plan (SAP), Clinical Study Report (CSR)) upon request from qualified researchers, and subject to certain criteria, conditions, and exceptions.
Further details on Pfizer's data sharing criteria and process for requesting access can be found at: https://www.pfizer.com/science/clinical_trials/trial_data_and_results/data_requests.
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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