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
ABOUT THIS STUDY
FOR MORE INFORMATION
Contact a representative by phone, email, or visiting the study website. Please see the references below:
Pfizer Clinical Trials Contact Center
1-800-718-1021
- 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.
- 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)
NEED INFO?
Questions about a trial? Call or email to reach a Pfizer Clinical Trial Contact Center Representative

TRY A NEW SEARCH
Search for Clinical Trials by condition, keyword or trial number. Share your location or enter your city or zip code to find studies near you.
Based on your search, you may also be interested in
- Vigo,
- Bregenz,
- Linz,
- Linz,
- Oberwart,
- Salzburg,
- Vienna,
- Wien,
- Wien,
- Aalst,
- Bonheiden,
- Gent,
- Gent,
- Ottignies,
- Nice Cedex 2, Alpes-maritimes
- Agen,
- Angers,
- Auxerre Cedex,
- Avignon cedex 2,
- Bayonne,
- Bordeaux Cedex,
- Bordeaux Cedex,
- Bordeaux,
- Bourg En Bresse Cedex,
- Cabestany,
- Carcassonne CEDEX 9,
- CERGY Pontoise,
- Chalon sur Saone,
- Clermont Ferrand Cedex 1,
- Clermont Ferrand Cedex 2,
- Clermont-Ferrand Cedex 1,
- Dijon,
- Dijon,
- Hyères,
- Lille,
- Limoges Cedex,
- Longjumeau,
- Lyon Cedex 09,
- Marseille Cedex 20,
- Marseille Cedex,
- Marseille Cedex,
- Metz Cedex,
- Metz,
- Montfermeil,
- Montpellier,
- Nancy,
- Nancy,
- Nimes cedex 9,
- Pau,
- Perigueux,
- Pierre Benite cedex,
- Pierre-bénite,
- Pringy Cedex,
- Pringy Cedex,
- Reims,
- Saint Gregoire Cedex,
- Saint Gregoire,
- Saint Pierre,
- Saint-Nazaire,
- St Brieuc,
- St Herblain Cedex,
- St PIERRE Cedex,
- Strasbourg,
- Strasbourg,
- Suresnes Cedex,
- Thonon les bains,
- Toulon,
- Valence,
- Valenciennes,
- Valenciennes,
- Vandoeuvre les Nancy,
- Athens,
- Meldola (FC),
- Milan,
- Napoli,
- Napoli,
- Pavia,
- Sabadell, Barcelona
- Terrassa, Barcelona
- Pamplona, Navarra
- A Coruña,
- Alcala de Henares,
- Alicante,
- Barcelona,
- Barcelona,
- Burgos,
- Gerona,
- Leon,
- Madrid,
- Madrid,
- Madrid,
- Madrid,
- Madrid,
- Murcia,
- Salamanca,
- Santa Cruz de Tenerife,
- Toledo,
- Valencia,
- Valencia,
- Valencia,
- Vigo,
- Cheltenham, Gloustershire
- Canterbury, Kent
- Guildford, Surrey
- Dundee, Tayside
- Bath,
- Cottingham,
- London,
- Manchester,
- Calgary, Alberta
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:
| ||||
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:
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 | 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:
Exclusion Criteria:
| ||||
Sex/Gender |
| ||||
Ages | 18 Years and older (Adult, Older Adult) | ||||
Accepts Healthy Volunteers | No | ||||
Contacts |
| ||||
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 |
| ||||
Responsible Party | Pfizer | ||||
Study Sponsor | Pfizer | ||||
Collaborators | Not Provided | ||||
Investigators |
| ||||
PRS Account | Pfizer | ||||
Verification Date | June 2020 |