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

NCT02184416

Last updated date
Study Location
Centro Médico
Vigo, , 36211, Spain
Contact
1-800-718-1021

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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)

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Metastatic Renal Cell Carcinoma (mRCC)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
NCT02184416
  1. Vigo,
  2. Bregenz,
  3. Linz,
  4. Linz,
  5. Oberwart,
  6. Salzburg,
  7. Vienna,
  8. Wien,
  9. Wien,
  10. Aalst,
  11. Bonheiden,
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  13. Gent,
  14. Ottignies,
  15. Nice Cedex 2, Alpes-maritimes
  16. Agen,
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  18. Auxerre Cedex,
  19. Avignon cedex 2,
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  25. Cabestany,
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  27. CERGY Pontoise,
  28. Chalon sur Saone,
  29. Clermont Ferrand Cedex 1,
  30. Clermont Ferrand Cedex 2,
  31. Clermont-Ferrand Cedex 1,
  32. Dijon,
  33. Dijon,
  34. Hyères,
  35. Lille,
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  37. Longjumeau,
  38. Lyon Cedex 09,
  39. Marseille Cedex 20,
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  50. Perigueux,
  51. Pierre Benite cedex,
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  53. Pringy Cedex,
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  55. Reims,
  56. Saint Gregoire Cedex,
  57. Saint Gregoire,
  58. Saint Pierre,
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  60. St Brieuc,
  61. St Herblain Cedex,
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  63. Strasbourg,
  64. Strasbourg,
  65. Suresnes Cedex,
  66. Thonon les bains,
  67. Toulon,
  68. Valence,
  69. Valenciennes,
  70. Valenciennes,
  71. Vandoeuvre les Nancy,
  72. Athens,
  73. Meldola (FC),
  74. Milan,
  75. Napoli,
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  78. Sabadell, Barcelona
  79. Terrassa, Barcelona
  80. Pamplona, Navarra
  81. A Coruña,
  82. Alcala de Henares,
  83. Alicante,
  84. Barcelona,
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  87. Gerona,
  88. Leon,
  89. Madrid,
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  95. Salamanca,
  96. Santa Cruz de Tenerife,
  97. Toledo,
  98. Valencia,
  99. Valencia,
  100. Valencia,
  101. Vigo,
  102. Cheltenham, Gloustershire
  103. Canterbury, Kent
  104. Guildford, Surrey
  105. Dundee, Tayside
  106. Bath,
  107. Cottingham,
  108. London,
  109. Manchester,
ALL GENDERS
18 Years+
years
MULTIPLE SITES
Metastatic Renal Cell Carcinoma (mRCC)Clinical Outcomes For Patients With Metastatic Renal Cell Carcinoma (mRCC) Who Received Sunitinib After 1st Line Immune-oncology (IO) Treatments
NCT04175262
  1. Calgary, Alberta
ALL GENDERS
0+
years
MULTIPLE SITES
Advanced Information
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 May 1, 2021
Estimated Primary Completion Date May 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
Ages 18 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers No
Contacts
Contact: Pfizer CT.gov Call Center1-800-718-1021[email protected]
Listed Location Countries Austria,   Belgium,   France,   Greece,   Italy,   Netherlands,   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
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/d….
Responsible Party Pfizer
Study Sponsor Pfizer
Collaborators Not Provided
Investigators
Study Director:Pfizer CT.gov Call CenterPfizer
PRS Account Pfizer
Verification Date June 2020