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"Retrospective Study to Identify Clinical Factors Related to a High Benefit of Axitinib in mRCC"

Last updated on December 5, 2018

FOR MORE INFORMATION
Study Location
Hospital Duran i Reynals
Hospitalet de Llobregat, Barcelona, 08908 Spain
Contact
1-800-718-1021
Eligibility criteria
Condition
The disease, disorder, syndrome, illness, or injury that is being studied.
Renal Cell Carcinoma
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

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

- Axitinib received out of the approved indication Patients who do not meet any of the
inclusion criteria

NCT03538717
Pfizer
Recruiting
"Retrospective Study to Identify Clinical Factors Related to a High Benefit of Axitinib in mRCC"

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"Retrospective Study to Identify Clinical Factors Related to a High Benefit of Axitinib in mRCC"
Análisis Retrospectivo De Factores Clínicos Asociados A Un Mayor Beneficio Con Axitinib En Cáncer Renal Metastásico. (Estudio Axilong)
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

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.

Observational
Observational Model: Cohort
Time Perspective: Retrospective
Not Provided
Not Provided
Non-Probability Sample

- 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
Carcinoma, Renal Cell
Not Provided
Not Provided
Not Provided


*   Includes publications given by the data provider as well as publications
identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruiting
60
Same as current
September 30, 2018
September 30, 2018   (Final data collection date for primary outcome measure)

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
Sexes Eligible for Study: All
18 Years and older   (Adult, Senior)
No

Contact: Pfizer CT.gov Call Center 1-800-718-1021 [email protected]
Spain
 
 
NCT03538717
A4061089
AXILONG ( Other Identifier: Alias Study Number )
No
Not Provided
Plan to Share IPD: No
Plan Description: Information relating to our policy on data sharing and the process for requesting data can be found at the following link: http://www.pfizer.com/research/clinical_trials/trial_data_and_results/da...
Pfizer
Pfizer
Not Provided
Study Director: Pfizer CT.gov Call Center Pfizer
Pfizer
May 2018

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