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Study Of The Impact Of Inlyta In 2nd Line On The Treatment Outcomes Of mRCC Patients Treated With Sutent In 1st Line In The Real Life Setting

Last updated on November 14, 2019

FOR MORE INFORMATION
Study Location
Centre Antoine Lacassagne, Service d'Oncologie
Nice Cedex 2, Alpes-maritimes, 06189 France
Contact
1-800-718-1021
Eligibility criteria
Condition
The disease, disorder, syndrome, illness, or injury that is being studied.
Metastatic Renal Cell Carcinoma (mRCC)
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

- Patient 18 years of age and over

- Histologically confirmed diagnosis of advanced/metastatic renal carcinoma (clear cell
RCC as well as non-clear cell RCC) with measurable disease according to RECIST 1.1

- Patients being treated with Sutent in 1st line according to the European therapeutic
indication and/or being treated with Inlyta in 2nd line according to the European
approved therapeutic indication (except post cytokines)

- Evidence of a personally signed and dated informed consent document indicating that
the patient (or a legally acceptable representative) has been informed of all
pertinent aspects of the study.

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

- Patients being treated with cytokines or any other treatment outside of Sutent in 1st
line

- Patients receiving anti -tumor treatment beyond a second line

- Patients already under Sutent, already under Inlyta: enrolment must occur at the
beginning of each line of treatment (before or at the first follow up visit at the
latest)

NCT02184416
Pfizer
Recruiting
Study Of The Impact Of Inlyta In 2nd Line On The Treatment Outcomes Of mRCC Patients Treated With Sutent In 1st Line In The Real Life Setting

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Descriptive Information
Brief TitleStudy Of The Impact Of Inlyta In 2nd Line On The Treatment Outcomes Of mRCC Patients Treated With Sutent In 1st Line In The Real Life Setting
Official TitleAXITINIB IN ADVANCED / METASTATIC RENAL CELL CARCINOMA - A NON-INTERVENTIONAL STUDY OF REAL WORLD TREATMENT OUTCOMES IN PATIENTS RECEIVING 2ND LINE AXITINIB AFTER 1ST LINE SUNITINIB (ADONIS)
Brief SummaryThis is an international, multi-centre, prospective (partly retrospective), observational study to evaluate treatment patterns and clinical outcomes in patients with advanced or metastatic RCC treated with sunitinib in first line and/or receiving axitinib in second line post sunitinib. The study is designed to enroll approximately 750 patients over the course of an enrollment period of approximately 36 months.
Detailed Description

Patients will be enrolled when they start a treatment with Sutent in 1st line or Inlyta in 2nd line post Sutent treatment. The possible sequences of treatment under investigation will be:

  • Sutent (prospective) - Inlyta
  • Sutent (retrospective) - Inlyta
  • Sutent - not further active treatment (supportive care)
  • Sutent - other second line treatment (Nexavar (sorafenib), Votrient (pazopanib), Afinitor (everolimus), Torisel (temsirolimus), other)) The study will enroll approximately 750 adv/mRCC patients at the 1st and 2nd line treatment level. Patients will be enrolled when they start a treatment with Sutent in 1st line or Inlyta in 2nd line post Sutent treatment. Therefore for some patients there will be a retrospective Sutent data collection. The primary endpoints of this study in patients with adv/mRCC are PFS and TTF for patients receiving Inlyta in 2nd line, and the combined PFS and TTF for patients receiving the Sutent-Inlyta sequence. In this non-interventional real life study, the objective is only descriptive and the sample size will rely on the precision of the estimate.
Study TypeObservational
Study DesignObservational Model: Other
Time Perspective: Other
Target Follow-Up DurationNot Provided
BiospecimenNot Provided
Sampling MethodNon-Probability Sample
Study PopulationThe study will enroll adv/mRCC patients when they start a treatment with Sutent in 1st line or Inlyta in 2nd line post Sutent treatment.
ConditionMetastatic Renal Cell Carcinoma (mRCC)
InterventionOther: observational
The study is non interventional. All drugs will be prescribed
Other Name: Nexavar (sorafenib), Votreint (pazopanib), Afinitor (everolimus), Torisel (temsirolimus)
Study Groups/CohortsObservational Arm

Patients will be enrolled when they start a treatment with Sutent in 1st line or Inlyta in 2nd line post Sutent treatment. The possible sequences of treatment under investigation will be:

  • Sutent (prospective) - Inlyta
  • Sutent (retrospective) - Inlyta
  • Sutent - not further active treatment (supportive care)
  • Sutent - other second line treatment (Nexavar (sorafenib), Votrient (pazopanib), Afinitor (everolimus), Torisel (temsirolimus), other))
Intervention: Other: observational
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 StatusRecruiting
Estimated Enrollment
 (submitted: July 3, 2014)
750
Original Estimated EnrollmentSame as current
Estimated Study Completion DateMay 1, 2021
Estimated Primary Completion DateMay 1, 2021   (Final data collection date for primary outcome measure)
Eligibility Criteria

Inclusion Criteria:

  • Patient 18 years of age and over
  • Histologically confirmed diagnosis of advanced/metastatic renal carcinoma (clear cell RCC as well as non-clear cell RCC) with measurable disease according to RECIST 1.1
  • Patients being treated with Sutent in 1st line according to the European therapeutic indication and/or being treated with Inlyta in 2nd line according to the European approved therapeutic indication (except post cytokines)
  • Evidence of a personally signed and dated informed consent document indicating that the patient (or a legally acceptable representative) has been informed of all pertinent aspects of the study.

Exclusion Criteria:

  • Patients being treated with cytokines or any other treatment outside of Sutent in 1st line
  • Patients receiving anti -tumor treatment beyond a second line
  • Patients already under Sutent, already under Inlyta: enrolment must occur at the beginning of each line of treatment (before or at the first follow up visit at the latest)
Sex/Gender
Sexes Eligible for Study:All
Ages18 Years and older   (Adult, Older Adult)
Accepts Healthy VolunteersNo
Contacts
Contact: Pfizer CT.gov Call Center1-800-718-1021[email protected]
Listed Location CountriesAustria,   Belgium,   France,   Italy,   Spain,   United Kingdom
Removed Location Countries  
 
Administrative Information
NCT NumberNCT02184416
Other Study ID NumbersA4061078
ADONIS ( Other Identifier: Alias Study Number )
Has Data Monitoring CommitteeNo
U.S. FDA-regulated ProductNot 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/da....
Responsible PartyPfizer
Study SponsorPfizer
CollaboratorsNot Provided
Investigators
Study Director:Pfizer CT.gov Call CenterPfizer
PRS AccountPfizer
Verification DateOctober 2019

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