Clinical trial NCT03538717: "Retrospective Study to Identify Clinical Factors Related to a High Benefit of Axitinib in mRCC"
Official title: Retrospective Analysis of Clinical Factors Associated With Greater Benefit of Axitinib in Metastatic Renal Cancer (AXILONG Study)
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Carcinoma, Renal Cell
Keywords: Axitinib,
Renal Carcinoma,
Long responders
Lead sponsor: Pfizer
Sponsor class: INDUSTRY
First posted: 2018-05-29
Enrollment: 157
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: RETROSPECTIVE
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

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.

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

Primary outcomes:
measure: Number of Participants With Age Less Than or Equal to (<=) 65 Years and Greater Than (>) 65 Years at Initiation of Axitinib Treatment: Long Responders Versus Refractory Participants
timeFrame: At initiation of axitinib treatment, within axitinib therapy of maximum 5.4 years approximately (from the data collected and observed retrospectively during 1 year)
measure: Number of Participants With Eastern Cooperative Oncology Group (ECOG) Performance Status Before First Line Treatment Initiation: Long Responders Versus Refractory Participants
timeFrame: Prior to first dose of first line treatment, within first line therapy of maximum 6.6 years approximately (from the data collected and observed retrospectively during 1 year)
measure: Number of Participants With Eastern Cooperative Oncology Group (ECOG) Performance Status at Initiation of Axitinib Treatment: Long Responders Versus Refractory Participants
timeFrame: At initiation of axitinib treatment, within axitinib therapy of maximum 5.4 years approximately (from the data collected and observed retrospectively during 1 year)
measure: Number of Participants With Eastern Cooperative Oncology Group (ECOG) Performance Status on Axitinib Discontinuation: Long Responders Versus Refractory Participants
timeFrame: On discontinuation of axitinib treatment, within axitinib therapy of maximum 5.4 years approximately (from the data collected and observed retrospectively during 1 year)
measure: Number of Participants With 1 or More Different Treatment Lines Before Axitinib Treatment Initiation: Long Responders Versus Refractory Participants
timeFrame: Prior to first dose of axitinib treatment, within axitinib therapy of maximum 5.4 years approximately (from the data collected and observed retrospectively during 1 year)
measure: Number of Participants With Nephrectomy Procedure Status Before Axitinib Treatment Initiation: Long Responders Versus Refractory Participants
timeFrame: Prior to first dose of axitinib treatment, within axitinib therapy of maximum 5.4 years approximately (from the data collected and observed retrospectively during 1 year)
measure: Number of Participants With Memorial Sloan Kettering Cancer Center (MSKCC) Risk Group Before First Line Treatment Initiation: Long Responders Versus Refractory Participants
timeFrame: Prior to first dose of first line treatment, within first line therapy of maximum 6.6 years approximately (from the data collected and observed retrospectively during 1 year)
measure: Number of Participants With Memorial Sloan Kettering Cancer Center (MSKCC) Risk Group at Initiation of Axitinib Treatment: Long Responders Versus Refractory Participants
timeFrame: At initiation of axitinib treatment, within axitinib therapy of maximum 5.4 years approximately (from the data collected and observed retrospectively during 1 year)
measure: Number of Participants With Memorial Sloan Kettering Cancer Center (MSKCC) Risk Group on Discontinuation of Axitinib Treatment: Long Responders Versus Refractory Participants
timeFrame: On discontinuation of axitinib treatment, within axitinib therapy during treatment of maximum 5.4 years, approximately (from the data collected and observed retrospectively during 1 year)
measure: Number of Participants With International Metastatic Database Consortium (IMDC) Risk Group at Initiation of Axitinib Treatment: Long Responders Versus Refractory Participants
timeFrame: At initiation of axitinib treatment, within axitinib therapy of maximum 5.4 years approximately (from the data collected and observed retrospectively during 1 year)
measure: Number of Participants With International Metastatic Database Consortium (IMDC) Risk Group on Discontinuation of Axitinib Treatment: Long Responders Versus Refractory Participants
timeFrame: On discontinuation of axitinib treatment, within axitinib therapy of maximum 5.4 years approximately (from the data collected and observed retrospectively during 1 year)
measure: Number of Participants With Different Type of Renal Cells Before Axitinib Treatment Initiation: Long Responders Versus Refractory Participants
timeFrame: Prior to first dose of axitinib treatment, within axitinib therapy of maximum 5.4 years approximately (from the data collected and observed retrospectively during 1 year)
measure: Number of Participants With Duration of First Line Treatment With Tyrosine Kinase Inhibitor (TKI) Before Axitinib Treatment Initiation: Long Responders Versus Refractory Participants
timeFrame: First dose of first line treatment, within first line therapy of maximum 6.6 years approximately (from the data collected and observed retrospectively during 1 year)
measure: Number of Participants With Best Response to First Line Treatment With Tyrosine Kinase Inhibitor (TKI) Before Axitinib Treatment Initiation: Long Responders Versus Refractory Participants
timeFrame: First dose of first line treatment, within first line therapy of maximum 6.6 years approximately (from the data collected and observed retrospectively during 1 year)
measure: Number of Participants With 1 or More Metastatic Locations at Diagnosis of Advance or Metastatic Renal Cell Carcinoma Before First Line Treatment Initiation: Long Responders Versus Refractory Participants
timeFrame: At diagnosis of advance or mRCC prior to first dose of first line treatment, within first line therapy of maximum 6.6 years approximately (from the data collected and observed retrospectively during 1 year)
measure: Number of Participants With Different Metastatic Sites Locations at Diagnosis of Advance or Metastatic Renal Cell Carcinoma Before Axitinib Treatment Initiation: Long Responders Versus Refractory Participants
timeFrame: At diagnosis of advance or mRCC prior to first dose of first line treatment, within first line therapy of maximum 6.6 years approximately (from the data collected and observed retrospectively during 1 year)
measure: Number of Participants With Laboratory Parameters at Initiation of First Line Treatment: Long Responders Versus Refractory Participants
timeFrame: At initiation of first line treatment, within first line therapy of maximum 6.6 years approximately (from the data collected and observed retrospectively during 1 year)
measure: Number of Participants With Smoking Habits at Initiation of First Line Treatment: Long Responders Versus Refractory Participants
timeFrame: At initiation of first line treatment, within first line therapy of maximum 6.6 years approximately (from the data collected and observed retrospectively during 1 year)
Secondary outcomes:
measure: Progression-free Survival (PFS) to Axitinib Treatment in Group of Long Responders
timeFrame: Day 1 of axitinib dose to disease progression or death due to any cause or date of latest follow-up in case of censored up to a maximum axitinib therapy of 5.4 years, approximately (from the data collected and observed retrospectively during 1 year)
measure: Time to Progression (TTP) to Axitinib Treatment in Group of Long Responders
timeFrame: Day 1 of axitinib dose to disease progression or date of latest follow-up in case of censored up to a maximum (max.)axitinib therapy duration of 5.4 years(yrs.)approximately(approx.)(from the data collected, observed retrospectively during 1 year [yr.])
measure: Overall Survival (OS) From Axitinib Treatment in Group of Long Responders
timeFrame: Day 1 of axitinib dose to death due to any cause or date of latest follow-up in case of censored up to a maximum axitinib therapy of 5.4 years, approximately (from the data collected and observed retrospectively during 1 year)
measure: Number of Participants With Best Response to Axitinib as Second Line of Treatment and Subsequent Treatment in Group of Long Responders
timeFrame: From first dose of axitinib as second line of treatment and from first dose of axitinib as subsequent treatment up to a maximum axitinib therapy duration of 5.4 years approximately (data collected and observed retrospectively for 1 year)
measure: Progression-free Survival (PFS) to Axitinib as Second Line of Treatment and Subsequent Treatment in Group of Long Responders
timeFrame: From first dose of axitinib as second line and from first dose of axitinib as subsequent lines to PD/death by any cause/date of latest follow-up if censored up to a max. axitinib therapy of 5.4 yrs. approx. (data collected, observed retrospectively 1 yr.)
measure: Objective Response Rate (ORR) to Axitinib as Second Line of Treatment and Subsequent Treatment in Group of Long Responders
timeFrame: From first dose of axitinib as second line of treatment and from first dose of axitinib as subsequent treatment up to a maximum axitinib therapy duration of 5.4 years approximately (data collected and observed retrospectively for 1 year)
measure: Clinical Benefit Rate (CBR) to Axitinib as the Second Line of Treatment and Subsequent Treatment in Group of Long Responders
timeFrame: From first dose of axitinib as second line of treatment and from first dose of axitinib as subsequent treatment up to a maximum axitinib therapy duration of 5.4 years approximately (data collected and observed retrospectively for 1 year)
measure: Time to Progression (TTP) to Axitinib as the Second Line of Treatment and Subsequent Treatment in Group of Long Responders
timeFrame: From first dose of axitinib as second line of treatment and from first dose of axitinib as subsequent treatment to PD/date of latest follow-up if censored up to max. treatment duration of 5.4 yrs., approx. (data collected, observed retrospectively 1 year)
measure: Overall Survival (OS) to Axitinib as the Second Line of Treatment and Subsequent Treatment in Group of Long Responders
timeFrame: From first dose of axitinib as second line of treatment and from first dose of axitinib as subsequent treatment to death due to any cause/date of latest follow-up if censored upto max. of 5.4 yrs., approx. (data collected, observed retrospectively 1 year)
measure: Duration of Axitinib Treatment: All Participants
timeFrame: Day 1 of axitinib treatment to end of treatment or date of latest follow-up if not suspended for maximum axitinib therapy duration of 5.4 years, approximately (from data collected and observed retrospectively for 1 year)
measure: Percentage of Participants With Titrated (Increased) Doses of Axitinib of More Than 5 Milligram (mg) Twice Daily: All Participants
timeFrame: For maximum axitinib treatment duration of 5.4 years, approximately (from data collected and observed retrospectively for 1 year)
measure: Percentage of Participants With Reduced Doses of Axitinib of More Than 5 Milligram (mg) Twice Daily: All Participants
timeFrame: For maximum axitinib treatment duration of 5.4 years, approximately (data collected and observed retrospectively for 1 year)
measure: Number of Participants With Adverse Events (AE): All Participants
timeFrame: For first line treatment: maximum of 6.6 years approximately; for axitinib treatment: maximum of 5.4 years approximately; for post-axitinib subsequent treatments: maximum of 2.9 years approximately (data collected and observed retrospectively for 1 year)
measure: Number of Participants Receiving Subsequent Treatment Post Axitinib Treatment: All Participants
timeFrame: Upon initiation of subsequent treatment (post axitinib treatment) to a maximum subsequent treatment duration of 2.9 years approximately (from data collected and observed retrospectively for 1 year)
measure: Number of Participants as Per Number of Subsequent Lines of Treatment Received Post Axitinib Treatment: All Participants
timeFrame: Upon initiation of subsequent treatment (post axitinib treatment) to a maximum subsequent treatment duration of 2.9 years approximately (from data collected and observed retrospectively for 1 year)
measure: Duration of Subsequent Treatments Post Axitinib Treatment: All Participants
timeFrame: Upon initiation of subsequent treatment (post axitinib treatment) to a maximum subsequent treatment duration of 2.9 years approximately (from data collected and observed retrospectively for 1 year)
measure: Number of Participants With First Best Response to Subsequent Treatments Post Axitinib Treatment
timeFrame: From initiation of subsequent treatment (post axitinib treatment) to a maximum subsequent treatment duration of 2.9 years approximately (from data collected and observed retrospectively for 1 year)
measure: Number of Participants With Reasons to Discontinue Subsequent Treatments Post Axitinib Treatment: All Participants
timeFrame: From initiation of subsequent treatment (post axitinib treatment) to a maximum subsequent treatment duration of 2.9 years approximately (from data collected and observed retrospectively for 1 year)
measure: Overall Survival (OS) From Subsequent Treatments Post Axitinib Treatment
timeFrame: From initiation of subsequent treatment (post axitinib treatment) to a maximum subsequent treatment duration of 2.9 years approximately (from data collected and observed retrospectively for 1 year)
Other outcomes:
Locations:
city: Hospitalet de Llobregat
country: Spain
facility: Hospital Duran i Reynals
state: Barcelona
city: Sabadell
country: Spain
facility: Hospital Universitario Parc Taulí
state: Barcelona
city: Tarragona
country: Spain
facility: Hospital Sant Pau i Santa Tecla
state: Barcelona
city: Terrassa
country: Spain
facility: Hospital Universitario Mutua Terrassa
state: Barcelona
city: Alcazar de San Juan
country: Spain
facility: Complejo Hospitalario la Mancha Centro
state: Ciudad REAL
city: Alcalá de Henares
country: Spain
facility: Hospital Universitario Principe de Asturias
state: Madrid
city: Alcorcón
country: Spain
facility: Hospital Universitario Fundacion Alcorcón
state: Madrid
city: Leganés
country: Spain
facility: Hospital Universitario Severo Ochoa
state: Madrid
city: Mostoles
country: Spain
facility: Hospital Universitario Rey Juan carlos
state: Madrid
city: Parla
country: Spain
facility: Hospital Infanta Cristina
state: Madrid
city: San Sebatián De Los Reyes
country: Spain
facility: Hospital Universitario Infanta Sofía
state: Madrid
city: Palma de Mallorca
country: Spain
facility: Hospital Universitario Son Espases
state: Mallorca
city: Pamplona
country: Spain
facility: HU de Navarra, Pamplona
state: Navarra
city: La Cuesta, Santa Cruz De Tenerife
country: Spain
facility: Hospital Universitario de Canarias
state: Tenerife
city: Santa Cruz de Tenerife
country: Spain
facility: Hospital Universitario Nuestra Señora de la Candelaria, Tenerife
state: Tenerife
city: Talavera de la Reina
country: Spain
facility: Hospita General Nuestra Señora del Prado
state: Toledo
city: Barcelona
country: Spain
facility: Hospital del Mar
city: Barcelona
country: Spain
facility: Hospital Universitario Vall d'Hebrón
city: Barcelona
country: Spain
facility: HU Clinic i Provincial
city: Barcelona
country: Spain
facility: Hospital Universitario Sant Pau i Santa Creu
city: Ciudad Real
country: Spain
facility: Hospital General Universitario de Ciudad Real
city: Córdoba
country: Spain
facility: Hospital Reina Sofía
city: Jaén
country: Spain
facility: Complejo Hospitalario de Jaén
city: León
country: Spain
facility: HU De León
city: Lugo
country: Spain
facility: Hospital Universitario Lucus Augusti (HULA_ Lugo)
city: Madrid
country: Spain
facility: Hospital Universitario Ramón y Cajal
city: Madrid
country: Spain
facility: Hospital Universitario Fundación Jimenez Diaz
city: Madrid
country: Spain
facility: Hospital Universitario 12 de Octubre
city: Madrid
country: Spain
facility: Hospital Universitario La Paz
city: Madrid
country: Spain
facility: Centro Integral Oncológico Clara Campal
city: Orense
country: Spain
facility: Complejo Hospitalario Universitario de Ourense CHUOU
city: Oviedo
country: Spain
facility: Hospital Universitario Central de Asturias
city: Santiago de Compostela
country: Spain
facility: Hospital Universitario Santiago de Compostela
city: Toledo
country: Spain
facility: Hospita Virgen de la Salud de Toledo
city: Valencia
country: Spain
facility: Instituto Valenciano de Oncología
city: Valencia
country: Spain
facility: Hospital Clínico Universitario de Valencia
city: Valencia
country: Spain
facility: Hospital Universitario y Politécnico La Fe
city: Vigo
country: Spain
facility: Hospital Universitario de Vigo- Hospital Álvaro Cunqueiro
city: Zaragoza
country: Spain
facility: H. Universitario Miguel Servet, Zaragoza
city: Zaragoza
country: Spain
facility: Hospital Clínico Uiversitario Lozano Blesa
Study officials:
affiliation: Pfizer
name: Pfizer CT.gov Call Center
role: STUDY_DIRECTOR
References: