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

Pfizer

Status: Completed

Conditions: Carcinoma, Renal Cell

Study type: Observational

Funder types: Industry

Identifiers

NCT03538717

AXILONG (Other Identifier)

A4061089

Details and patient eligibility

About

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

Full 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.

Enrollment: 157 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design