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Trial record 1 of 1 for:    NCT03538717
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"Retrospective Study to Identify Clinical Factors Related to a High Benefit of Axitinib in mRCC"

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ClinicalTrials.gov Identifier: NCT03538717
Recruitment Status : Completed
First Posted : May 29, 2018
Last Update Posted : May 3, 2019
Sponsor:
Information provided by (Responsible Party):
Pfizer

Tracking Information
First Submitted Date January 19, 2018
First Posted Date May 29, 2018
Last Update Posted Date May 3, 2019
Actual Study Start Date April 19, 2018
Actual Primary Completion Date March 1, 2019   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures
 (submitted: May 24, 2018)
Rate of patients with clinical characteristics which are significant associated with PFS longer than 9 months. Comparison of clinical profile of patients with PFS longer than 9months vs refractory patients [ Time Frame: Throught study completion, an average of 9 months. ]
Diferences in the clinical profile of patients who have achieved a good response to Axitinib (PFS longer than 9 months) vs Axitinib refractory patients (PD as best response). Number of patients with clinical characteristics which are significant associated with PFS longer than 9 months.
Original Primary Outcome Measures Same as current
Change History
Current Secondary Outcome Measures Not Provided
Original Secondary Outcome Measures Not Provided
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title "Retrospective Study to Identify Clinical Factors Related to a High Benefit of Axitinib in mRCC"
Official Title ANÁLISIS RETROSPECTIVO DE FACTORES CLÍNICOS ASOCIADOS A UN MAYOR BENEFICIO CON AXITINIB EN CÁNCER RENAL METASTÁSICO. (ESTUDIO AXILONG)
Brief Summary Retrospective study to collect data from Patients with advanced/metastatic renal cell carcinoma previously treated with Axitinib under standard clinical practice, to describe the clinical profile of the patients with a long response to Axitinib and to try to identify clinical factors which could be related with the long response to Axitinib, through the comparison between long responder patients and a group of refractory patients
Detailed Description

To describe the clinical profile of patients with a long response to Axitinib and to identify clinical factors which could be related with the long response to Axitinib, through the comparison between long responder patients and a group of refractory patients.

For this study are defined as "long responder", those patients who has a Progression Free Survival (PFS) of at least 9 months since the initiation of Axitinib treatment, and "refractory patients" those who have Progression Disease (PD) in the first response assessment since the initiation of Axitinib treatment (estimated PFS ≤3 months]

Secondary Objectives

  • To describe the efficacy of Axitinib treatment in the long responders group, and in relation with the treatment received before Axitinib, in terms of PFS, ORR, CB, OS, TTP ...
  • To describe the tolerability and drug management of Axitinib in this population.
  • To describe treatment received after Axitinib in this population.

Study procedures:

For the recruitment, the Investigator should review the inclusion / exclusion criteria. In case of patients alive at the moment of the inclusion, the investigator will require them to sign the IC.

With the data available in the medical records, the information requested will be recorded in the electronic data collection tool.

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

- Age ≥ 18 years

  • Patients with advanced or metastatic renal cell carcinoma, histologically confirmed, with at least one radiological response assessment
  • Patients who had received Axitinib treatment in second or further line with a PFS ≥9 months or DP (disease progression) at the first tumor assessment.
  • For the patients alive at the moment of the inclusion, patients must have a signed informed consent document
Condition Carcinoma, Renal Cell
Intervention Not Provided
Study Groups/Cohorts Not Provided
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 Completed
Actual Enrollment
 (submitted: April 8, 2019)
167
Original Estimated Enrollment
 (submitted: May 24, 2018)
60
Actual Study Completion Date March 1, 2019
Actual Primary Completion Date March 1, 2019   (Final data collection date for primary outcome measure)
Eligibility Criteria

Inclusion Criteria:

  • Age ≥ 18 years

    • Patients with advanced or metastatic renal cell carcinoma, histologically confirmed, with at least one radiological response assessment
    • Patients who had received Axitinib treatment in second or further line with a PFS ≥9 months or DP (disease progression) at the first tumor assessment.
    • For the patients alive at the moment of the inclusion, patients must have a signed informed consent document

Exclusion Criteria:

  • Axitinib received out of the approved indication Patients who do not meet any of the inclusion criteria
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 Spain
Removed Location Countries  
 
Administrative Information
NCT Number NCT03538717
Other Study ID Numbers A4061089
AXILONG ( Other Identifier: Alias Study Number )
Has Data Monitoring Committee No
U.S. FDA-regulated Product Not Provided
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.
Responsible Party Pfizer
Study Sponsor Pfizer
Collaborators Not Provided
Investigators
Study Director: Pfizer CT.gov Call Center Pfizer
PRS Account Pfizer
Verification Date May 2019