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Trial record 1 of 1 for:    NCT02184416
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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 (ADONIS)

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ClinicalTrials.gov Identifier: NCT02184416
Recruitment Status : Recruiting
First Posted : July 9, 2014
Last Update Posted : September 11, 2018
Sponsor:
Information provided by (Responsible Party):
Pfizer

Tracking Information
First Submitted Date July 2, 2014
First Posted Date July 9, 2014
Last Update Posted Date September 11, 2018
Actual Study Start Date October 31, 2014
Estimated Primary Completion Date July 20, 2019   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures
 (submitted: July 3, 2014)
  • Progression-Free Survival (PFS) [ Time Frame: 60 months ]
    PFS for patients with adv/mRCC receiving Inlyta in 2nd line post Sutent is defined as the time from when the patient receives the first dose of Inlyta to the time of progression or death due to any cause, whichever occurs first
  • Progression-Free Survival (PFS) [ Time Frame: 60 months ]
    Combined PFS for patients with adv/mRCC receiving the Sutent-Inlyta sequence is defined as the time from when the patient receives the first dose with Sutent in first line, until progression or death due to any cause with Inlyta in 2nd line, whichever occurs first during the Sutent-Inlyta sequence
  • Time to Treatment Failure (TTF) [ Time Frame: 60 months ]
    TTF for Inlyta 2nd line is defined as from when the patient receives the first dose of Inlyta to the time of Inlyta discontinuation (date completed by the physician).
  • Time to Treatment Failure (TTF) [ Time Frame: 60 months ]
    TTF for the Sutent-Inlyta sequence is defined as the time from when the patient receives the first dose with Sutent in first line to the time of Inlyta discontinuation (date completed by the physician).
Original Primary Outcome Measures Same as current
Change History Complete list of historical versions of study NCT02184416 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures
 (submitted: July 3, 2014)
  • Overall Response Rate (ORR) [ Time Frame: 60 months ]
    ORR for adv/mRCC patients receiving Inlyta in 2nd line post Sutent defined as the percentage of patients with confirmed complete response (CR) or confirmed partial response (PR) according to RECIST criteria v1.1, relative to all patients who have baseline measurable disease.
  • Overall Survival (OS) [ Time Frame: 60 months ]
    OS for adv/mRCC patients receiving Sutent in first line followed by Inlyta in 2nd line as measured from the date of first Sutent dose to the date of death of any cause.
  • Time to strategy failure (TSF) [ Time Frame: 60 months ]
    TSF for patients receiving the Sutent-Inlyta sequence is defined as the time from when the patient receives the first dose with Sutent in first line to the time of Inlyta discontinuation (date completed by the physician) without the time between discontinuation of Sutent and start of Inlyta.
  • Dosing [ Time Frame: 60 months ]
    Description of real life usage of flexible dosing across Europe with description of treatment schedules (dosing change, dosing schedule, average dose received during the period treatment)
  • Proportion of titrated patients [ Time Frame: 60 months ]
    A patient is considered as titrated when an Inlyta dose increase is maintained for at least 4 weeks.
  • Progression-Free Survival (PFS) [ Time Frame: 60 months ]
    PFS for titrated and non-titrated patients when they receive Inlyta in 2nd line post Sutent
  • Efficacy [ Time Frame: 60 months ]
    Efficacy parameters (PFS, OS) for the combined 1st line Sutent - 2nd line sequences according to the second line post Sutent (other than Sutent-Inlyta)
  • Safety [ Time Frame: 60 months ]
    Safety description with AE listing in patients receiving Inlyta
  • QoL [ Time Frame: 60 months ]
    QoL using the Functional Assessment of Cancer Therapy-Kidney Symptom Index 19 (FKSI-19) questionnaire and the Mental Health (MH) and Role-Emotional (RE) domains of the SF-36 questionnaire.
Original Secondary Outcome Measures Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title 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
Official Title Axitinib 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 Summary This 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 Type Observational
Study Design Observational Model: Other
Time Perspective: Other
Target Follow-Up Duration Not Provided
Biospecimen Not Provided
Sampling Method Non-Probability Sample
Study Population The study will enroll adv/mRCC patients when they start a treatment with Sutent in 1st line or Inlyta in 2nd line post Sutent treatment.
Condition Metastatic Renal Cell Carcinoma (mRCC)
Intervention Other: observational
The study is non interventional. All drugs will be prescribed
Other Name: Nexavar (sorafenib), Votreint (pazopanib), Afinitor (everolimus), Torisel (temsirolimus)
Study Groups/Cohorts Observational 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 Status Recruiting
Estimated Enrollment
 (submitted: July 3, 2014)
750
Original Estimated Enrollment Same as current
Estimated Study Completion Date July 20, 2019
Estimated Primary Completion Date July 20, 2019   (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
Ages 18 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers No
Contacts
Contact: Pfizer CT.gov Call Center 1-800-718-1021 ClinicalTrials.gov_Inquiries@pfizer.com
Listed Location Countries Austria,   Belgium,   France,   Italy,   Spain,   United Kingdom
Removed Location Countries  
 
Administrative Information
NCT Number NCT02184416
Other Study ID Numbers A4061078
ADONIS ( Other Identifier: Alias Study Number )
Has Data Monitoring Committee No
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement Not Provided
Responsible Party Pfizer
Study Sponsor Pfizer
Collaborators Not Provided
Investigators
Study Director: Pfizer CT.gov Call Center Pfizer
PRS Account Pfizer
Verification Date September 2018