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

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ClinicalTrials.gov Identifier: NCT04033991
Recruitment Status : Not yet recruiting
First Posted : July 26, 2019
Last Update Posted : September 23, 2019
Sponsor:
Information provided by (Responsible Party):
Pfizer

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)?

Condition or disease Intervention/treatment
Carcinoma Renal Cell Drug: Sunitinib Drug: Axitinib

  Show Detailed Description

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Study Type : Observational
Estimated Enrollment : 841 participants
Observational Model: Cohort
Time Perspective: Retrospective
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
Estimated Study Start Date : September 2019
Estimated Primary Completion Date : January 1, 2020
Estimated Study Completion Date : January 1, 2020

Resource links provided by the National Library of Medicine


Group/Cohort Intervention/treatment
Patients with advanced RCC
Patients with a diagnosis of kidney cancer (renal cell carcinoma, advanced or metastatic)
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




Primary Outcome Measures :
  1. Progression free survival (PFS) for first line treatment with sunitinib [ Time Frame: Up to 120 months from inclusion in study database, or until death, whichever is longer. ]
    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. Progression Free Survival (PFS) for second line treatment with axitinib [ Time Frame: Up to 120 months from inclusion in study database, or until death, whichever is longer. ]
    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 Outcome Measures :
  1. Overall survival (first and second line treatments) [ Time Frame: Up to 120 months from inclusion in study database, or until death, whichever is longer. ]
    What is the overall survival (OS) of all patients in first/second line with sunitinib/axitinib, and stratified by MSKCC risk (favourable, intermediate, poor)?

  2. Time to treatment discontinuation [ Time Frame: Up to 120 months from inclusion in study database, or until death, whichever is longer. ]
    What is the duration of therapy with sunitinib in first line/ axitinib in second line (using time to treatment discontinuation [TTD]) for all patients and stratified by MSKCC risk (favourable, intermediate, poor)

  3. Objective Response Rate (ORR) [ Time Frame: Up to 120 months from inclusion in study database, or until death, whichever is longer. ]
    ORR for first line sunitinib or second line axitinib

  4. Duration of partial or complete response [ Time Frame: Up to 120 months from inclusion in study database, or until death, whichever is longer. ]
    First line sunitinib or second line axitinib

  5. Examine factors that predict TTD, e.g. risk stratification, or individual/grouped parameters that comprise the prognostic classification systems [ Time Frame: Up to 120 months from inclusion in study database, or until death, whichever is longer. ]
    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 data [ Time Frame: Up to 120 months from inclusion in study database, or until death, whichever is longer. ]
    Safety and tolerability data reporting for first line sunitinib and second line axitinib



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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.
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04033991


Contacts
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Contact: Pfizer CT.gov Call Center 1-800-718-1021 ClinicalTrials.gov_Inquiries@pfizer.com

Sponsors and Collaborators
Pfizer
Investigators
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Study Director: Pfizer CT.gov Call Center Pfizer

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Responsible Party: Pfizer
ClinicalTrials.gov Identifier: NCT04033991     History of Changes
Other Study ID Numbers: X9001180
First Posted: July 26, 2019    Key Record Dates
Last Update Posted: September 23, 2019
Last Verified: September 2019
Individual Participant Data (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/data_requests.

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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
Keywords provided by Pfizer:
Carcinoma, renal cell, cancer, kidney, sunitinib, axitinib
Additional relevant MeSH terms:
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Carcinoma
Carcinoma, Renal Cell
Neoplasms, Glandular and Epithelial
Neoplasms by Histologic Type
Neoplasms
Adenocarcinoma
Kidney Neoplasms
Urologic Neoplasms
Urogenital Neoplasms
Neoplasms by Site
Kidney Diseases
Urologic Diseases
Sunitinib
Axitinib
Antineoplastic Agents
Angiogenesis Inhibitors
Angiogenesis Modulating Agents
Growth Substances
Physiological Effects of Drugs
Growth Inhibitors
Protein Kinase Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action