Study of Patients With Metastatic and/or Advanced Renal Cell Carcinoma, Treated With Sunitinib/Axitinib.

NCT04033991

Last updated date
Study Location
Pfizer
London, , , United Kingdom
Contact
1-800-718-1021

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Eligibility Criteria
condition
The disease, disorder, syndrome, illness, or injury that is being studied.
Carcinoma, Renal Cell
Sex
Females and Males
Age
Pediatric Trials: 0-17 Years
Adult Trials: 18+ Years
18 + years
Inclusion Criteria
The factors, or reasons, that allow a person to participate in a clinical study.
Show details

1. Over the age of 18 years

2. Diagnosis of renal cell carcinoma

3. Treatment with sunitinib and/or axitinib

4. Timeframe: from database inception date (2002) until the end of June 2017.

Exclusion Criteria
The factors, or reasons, that prevent a person from participating in a clinical study.
Show details


Patients meeting any of the following criteria will not be included in the study:


1. Under the age of 18 years


2. Diagnosis other than renal cell carcinoma


3. No treatment with sunitinib and/or axitinib

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Advanced Information
Descriptive Information
Brief Title Study of Patients With Metastatic and/or Advanced Renal Cell Carcinoma, Treated With Sunitinib/Axitinib.
Official Title A Real World Retrospective Database Study of Patients Diagnosed With Metastatic and/or Advanced Renal Cell Carcinoma and Treated With Sunitinib and/or Axitinib in a Specialist United Kingdom Oncology Centre
Brief Summary

Research Questions:

To understand the clinical outcomes of patients treated with sunitinib in first line and axitinib in second line in a real world setting as therapies for metastatic and/or advanced renal cell carcinoma (mRCC).

Primary Objective:

  1. What is the progression free survival (PFS) of patients treated in first line with sunitinib, and stratified by Memorial Sloan-Kettering Cancer Center / International Metastatic Renal Cell Carcinoma Database Consortium (MSKCC/IMDC) risk category (favourable, intermediate, poor)?
  2. What is the progression free survival (PFS) of patients treated in second line with axitinib, and stratified by MSKCC/IMDC risk category (favourable, intermediate, poor)?
Detailed Description

Research Questions:

To understand the clinical outcomes of patients treated with sunitinib in first line and axitinib in second line in a real world setting as therapies for metastatic and/or advanced renal cell carcinoma (mRCC).

Primary Objective:

  1. What is the progression free survival (PFS) of patients treated in first line with sunitinib, and stratified by Memorial Sloan-Kettering Cancer Center / International Metastatic Renal Cell Carcinoma Database Consortium (MSKCC/IMDC) risk category (favourable, intermediate, poor)?
  2. What is the progression free survival (PFS) of patients treated in second line with axitinib, and stratified by MSKCC/IMDC risk category (favourable, intermediate, poor)?

Secondary Objectives:

First Line:

  1. What is the overall survival (OS) of all patients in first line with sunitinib, and stratified by MSKCC risk (favourable, intermediate, poor)?
  2. What is the duration of therapy with sunitinib in first line (using time to treatment discontinuation [TTD]) for all patients and stratified by MSKCC risk (favourable, intermediate, poor)
  3. Objective response rate (ORR)
  4. Duration of objective response (complete response [CR] or partial response [PR])
  5. Examine factors that predict TTD, e.g. risk stratification, or individual/grouped parameters that comprise the prognostic classification systems

    1. Less than one year from time of diagnosis
    2. Karnovsky performance status less than 80%
    3. Haemoglobin less than the lower limit of normal (e.g. less than 12 g/dl)
    4. Serum calcium great than the upper limit of normal (e.g. 10 mg/dl or : 2.5 mmol/l)
    5. Neutrophil greater than the upper limit of normal (e.g. greater than 7.0 x109 dl)
    6. Platelets greater than the upper limit of normal (e.g. greater than 400 000)
    7. Lactate dehydrogenase greater than 1.5 times the upper limit of normal
    8. Fuhrmann grade of tumour
    9. Tumour subtype e.g. clear cell versus. non-clear cell
  6. Safety and tolerability data reporting for first line sunitinib

Second line:

  1. What is the OS of all patients in second line with axitinib, and stratified by MSKCC risk (favourable, intermediate, poor)?
  2. What is the duration of therapy with axitinib in second line (using TTD) for all patients and stratified by MSKCC risk (favourable, intermediate, poor)
  3. ORR
  4. Duration of objective response (CR or PR)
  5. Examine factors that predict duration of TTD, e.g. risk stratification, or individual/grouped parameters that comprise the prognostic classification systems

    1. Less than one year from time of diagnosis
    2. Karnovsky performance status less than 80%
    3. Haemoglobin less than the lower limit of normal (e.g. less than 12 g/dl)
    4. Serum calcium great than the upper limit of normal (e.g. 10 mg/dl or : 2.5 mmol/l)
    5. Neutrophil greater than the upper limit of normal (e.g. greater than 7.0 x109 dl)
    6. Platelets greater than the upper limit of normal (e.g. greater than 400 000)
    7. Lactate dehydrogenase greater than 1.5 times the upper limit of normal
    8. Fuhrmann grade of tumour
    9. Tumour subtype e.g. clear cell vs. non-clear cell
  6. Safety and tolerability reporting for second line axitinib

The objectives listed below will also be assessed as exploratory analyses for various patient subgroups of interest, and will be conducted if sufficient numbers of patients are available:

  1. Axitinib PFS and OS, as a second line therapy following sunitinib, pazopanib, or following other Tyrosine kinase inhibitors (e.g. sorafenib)
  2. Axitinib PFS and OS as a third line therapy
  3. Axitinib PFS and OS post-immunotherapy (IO), taking into consideration 2nd and 3rd therapy lines, following all IO therapy options, E.g. atezolizumab/bevacizumab, nivolumab/ipilumimab, nivolumab, interleukin-2
  4. For the post-sunitinib axitinib cohort: What was the duration of sunitinib therapy before patients transitioned to axitinib?
  5. For the post-pazopanib axitinib cohort: What was the duration of sunitinib therapy before patients transitioned to axitinib?
  6. Is the duration of therapy on first line sunitinib and/or pazopanib related to duration of therapy for second line axitinib?
Study Type Observational
Study Design Observational Model: Cohort
Time Perspective: Retrospective
Target Follow-Up Duration Not Provided
Biospecimen Not Provided
Sampling Method Non-Probability Sample
Study Population
  1. Over the age of 18 years
  2. Diagnosis of renal cell carcinoma
  3. Treatment with sunitinib and/or axitinib
  4. Timeframe: from database inception date (2002) until the end of June 2017.
Condition
  • Carcinoma
  • Renal Cell
Intervention
  • Drug: Sunitinib
    Tyrosine kinase inhibitor, licensed for use in treatment of renal cell carcinoma.
    Other Name: Sutent
  • Drug: Axitinib
    Tyrosine kinase inhibitor, licensed for use in treatment of renal cell carcinoma.
    Other Name: Inlyta
Study Groups/Cohorts Patients with advanced RCC
Patients with a diagnosis of kidney cancer (renal cell carcinoma, advanced or metastatic)
Interventions:
  • Drug: Sunitinib
  • Drug: Axitinib
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status Active, not recruiting
Estimated Enrollment
 (submitted: July 25, 2019)
841
Original Estimated Enrollment Same as current
Estimated Study Completion Date May 31, 2020
Estimated Primary Completion Date May 31, 2020   (Final data collection date for primary outcome measure)
Eligibility Criteria

Inclusion criteria

  1. Over the age of 18 years
  2. Diagnosis of renal cell carcinoma
  3. Treatment with sunitinib and/or axitinib
  4. Timeframe: from database inception date (2002) until the end of June 2017.

Exclusion criteria

Patients meeting any of the following criteria will not be included in the study:

  1. Under the age of 18 years
  2. Diagnosis other than renal cell carcinoma
  3. No treatment with sunitinib and/or axitinib
Sex/Gender
Sexes Eligible for Study:All
Ages 18 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers No
Contacts Contact information is only displayed when the study is recruiting subjects
Listed Location Countries United Kingdom
Removed Location Countries  
 
Administrative Information
NCT Number NCT04033991
Other Study ID Numbers X9001180
Has Data Monitoring Committee No
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
Product Manufactured in and Exported from the U.S.: No
IPD Sharing Statement
Plan to Share IPD:No
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/d….
Responsible Party Pfizer
Study Sponsor Pfizer
Collaborators Not Provided
Investigators
Study Director:Pfizer CT.gov Call CenterPfizer
PRS Account Pfizer
Verification Date December 2019