Study Details. Study Type: Observational Study Design: Observational Model: Cohort, Time Perspective: Prospective. Investigator Details

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1 Registry For Temsirolimus, Sunitinib, And Axitinib Treated Patients With Metastatic Renal Cell Carcinoma (mrcc), Mantle Cell Lymphoma (MCL), And Gastro-Intestinal Stroma Tumor (GIST) [STAR-TOR] Status: Recruiting Study Phase: N/A Start Date: January 2013 Completion Date: December 2017 Condition(s): Carcinoma, Renal Cell, Advanced, Lymphoma, Mantle-Cell, Gastrointestinal Stroma Tumors Full Title of Study Star-tor - Registry For The Evaluation Of The Safety, Tolerability And Efficacy Of Temsirolimus (Torisel ), Sunitinib (Sutent ), And Axitinib (Inlyta ) For The Treatment Of Subjects With Advanced Renal Cell Carcinoma (MRCC), Mantle Cell Lymphoma (MCL), And Gastro-intestinal Stroma Tumor (GIST). Overview The purpose of this registry is to obtain a general view as regards efficacy, tolerability and safety issues of the Torisel, Sutent, and/or Inlyta therapies in patients with advanced renal cell carcinoma, recurrent / refractory mantle cell lymphoma (MCL) and gastro-intestinal stroma tumors (GIST) under the conditions of routine use Detailed Description Treatment of the metastatic renal cell carcinoma (mrcc) has experienced fundamental changes within a very short period of time. In the past few years, introduction of various new substances for the treatment of mrcc has therefore resulted in new scientific research questions. Temsirolimus and sunitinib are current standard therapies in the first-line treatment of mrcc. Inlyta is a new substance that was developed for the treatment of mrcc after failure of sunitinib or cytokines. Since August 2009, Torisel is available as another treatment option for patients with mantle cell lymphoma (MCL). In addition, Sutent is used for patients with non-

2 resectable / metastatic gastro-intestinal stroma tumors (GIST) after failure or intolerability of imatinib. The routine use of drugs in the usual clinical setting faces additional challenges that generally cannot be completely reflected by clinical trials. Therefore, the purpose of this registry is to obtain a general view as regards efficacy, tolerability and safety issues of the Torisel, Sutent, and/or Inlyta therapies in patients with advanced renal cell carcinoma, recurrent / refractory mantle cell lymphoma (MCL) and gastro-intestinal stroma tumors (GIST) under the conditions of routine use. Therefore, the following information is of particular interest in the course of the investigation: - Efficacy (best response, overall survival, progression-free survival) - Tolerability of the therapy (assessed by the physician) - Safety profile (overall incidence of adverse events as well as side-effect rate) of subjects with mrcc, rmcl, and GIST under treatment with Torisel, Sutent, and/or Inlyta - Profile, comorbidities, and characteristics of subjects treated with Torisel Sutent, and/or Inlyta - The sequence of using the systemic therapies for RCC, MCL, and GIST - Patient survey on the quality of life of mrcc patients Study Details Study Type: Observational Study Design: Observational Model: Cohort, Time Perspective: Prospective Investigator Details Lead Sponsor: Pfizer Study Director: Pfizer CT.gov Call Center Pfizer Trial Location Details

3 Facility: Dr. med. Harald Held Neumuenster, Germany Facility: Dr. med. Hans Wilhelm Duebbers Ahaus, Germany Facility: Dr. Ludwig Fischer von Weikersthal Amberg, Germany Facility: Studienzentrum Drs. Klausmann / Dr. Welslau, Haematologie-Onkologie- Diabetologie Aschaffenburg, Germany Facility: Carsten Lange Bernburg, Germany Facility: Office of Ulrich Kube Chemnitz, Germany Facility: Dr. Jens-Uwe Krieger Chemnitz, Germany Facility: Zeisigwaldklinikum Bethanien Chemnitz Chemnitz, Germany Facility: Leonhard Stark Deggendorf, Germany Facility: Prof. Dr. med. Udo Rebmann Dessau, Germany Facility: Dr.med Johannes Mohm Dresden, Germany Facility: Dr. med. Ralf Eckert Eisleben, Germany Facility: Specialist Urology Erfurt, Germany Facility: Goebell Erlangen, Germany Facility: Prof. Dr. med. Lothar Bergmann Frankfurt am Main, Germany Facility: Dr. med. Gunter Derigs Frankfurt am Main, Germany Facility: Hoffkes Fulda, Germany Facility: PD Dr. Uwe Zimmermann Greifswald, Germany Facility: Internistische Gemeinschaftspraxis Guestrow, Germany Facility: Dr. med. Arne Strauss Göttingen, Germany Facility: Dr. med. Michael Rink Hamburg, Germany Facility: Dr. med. Hanns-Detlev Harich Hof, Germany Facility: Universitaetsklinikum des Saarlandes, Klinik fuer Urologie und Kinderurologie Homburg/Saar, Germany Facility: Dr. med. Susan Foller Jena, Germany Facility: Steinmetz Koeln, Germany Facility: Klinisches Studienzentrum Urlogie Koeln, Germany Facility: Dr. med. Martina Stauch Kronach, Germany

4 Facility: Dr. med. Ursula Vehling-Kaiser Landshut, Germany Facility: Dr. Andreas Kohler Langen, Germany Facility: Dietel Leipzig, Germany Facility: Andreas Schwarzer Leipzig, Germany Facility: Lutz Kamann Leipzig, Germany Facility: Dr.med. Matthias Schulze Markkleeberg, Germany Facility: Institut of Healthcare Research Mayen, Germany Facility: Dr. med. Jan Klaus Schroder Mulheim, Germany Facility: Dr.med. Wolfgang Abenhardt München, Germany Facility: Herrmann Münster, Germany Facility: Dr. med. Thomas Gehring Neckarsulm, Germany Facility: Dres. Derouet Poenicke Becker Neunkirchen, Germany Facility: Physician for Internal Medicine Neuwied, Germany Facility: Dr. med. David Kunst Nienburg, Germany Facility: Dr.med. Christian Linder Nordhausen, Germany Facility: Dr. med. Joachim Zimber Nürnberg, Germany Facility: Ralf-Bodo Kühn Oldenburg, Germany Facility: Wolfgang Marz Osnabruck, Germany Facility: Dr. med. Torsten Geyer Ostfildern, Germany Facility: Dr. med. Ino Kietz Parchim, Germany Facility: Office of Friedrich Overkamp, Oncologia Nova Recklinghausen, Germany Facility: Andreas Hübner Rostock, Germany Facility: Diakonie-Klinikum ggmbh Schwäbisch Hall, Germany Facility: Dr. med. Thomas Geer Schwäbisch Hall, Germany Facility: Office of Judith Franz-Werner Speyer, Germany Facility: Dr. Matthias Groschek Stolberg, Germany Facility: Dr. med. Heinz Kirchen Trier, Germany Facility: Klinik für Urologie, Eberhard-Karls-Universitaet Tuebingen, Tuebingen, Germany Facility: Klotz Weiden, Germany

5 Facility: Dr.med. Jan Janssen Westerstede, Germany Facility: Universitaetsklinik Wuerzburg, Medizinische Poliklinik Wuerzburg, Germany Facility: Jochen Gleissner Wuppertal, Germany Facility: Mathias Schulze Zittau, Germany Facility: Scheffler Zwickau, Germany Interventions Drug: Temsirolimus Drug: Temsirolimus Drug: Sunitinib Drug: Sunitinib Drug: Axitinib Information Source ID Number: 3066K NCT Identifier: NCT Health Authority: Germany: BfArM (Bundesinstitut fuer Arzneimittel und Medizinprodukte) Full Source of Clinical Trial Data: ClinicalTrials.gov processed this data on June 30, 2016 Clinical trials entries are delivered from the US National Institutes of Health and are not reviewed separately by this site. Please see the full source link above for retrieving further details from the government database.