PLEASE NOTE: This study has been imported from ClinicalTrials.gov without additional data checks.

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1 PLEASE NOTE: This study has been imported from ClinicalTrials.gov without additional data checks. Trial Description Title STAR-TOR- Registry For The Evaluation Of The Safety, Tolerability And Efficacy Of Temsirolimus (Torisel ), Sunitinib (Sutent ), And Axiitnib (Inlyta ) For The Treatment Of Subjects With Advanced Renal Cell Carcinoma (mrcc), Mantle Cell Lymphoma (MCL), And Gastro-Intestinal Stroma Tumor (GIST) Trial Acronym STAR-TOR URL of the trial [---]* Brief Summary in Lay Language 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 Brief Summary in Scientific Language Survival time analysis Organizational Data DRKS-ID: DRKS Date of Registration in Partner Registry or other Primary Registry: 2008/06/13 Investigator Sponsored/Initiated Trial (IST/IIT): no Ethics Approval/Approval of the Ethics Committee: [---]* (leading) Ethics Committee Nr.: [---]* Page 1 of 7

2 Secondary IDs Primary Registry-ID: NCT (ClinicalTrials.gov) Sponsor-ID: 3066K (Pfizer) Other Secondary-ID: B Health condition or Problem studied Free text: Carcinoma, Renal Cell, Advanced Free text: Lymphoma, Mantle-Cell Free text: Gastrointestinal Stroma Tumors ICD10: C64 - Malignant neoplasm of kidney, except renal pelvis ICD10: C Other non-follicular lymphoma Interventions/Observational Groups Arm 1: Drug: Temsirolimus Arm 2: Drug: Temsirolimus Arm 3: Drug: Sunitinib Arm 4: Drug: Sunitinib Arm 5: Drug: Axitinib Characteristics Study Type: Non-interventional Study Type Non-Interventional: Observational study Allocation: [---]* Blinding: [---]* Who is blinded: [---]* Control: [---]* Purpose: [---]* Assignment: [---]* Phase: N/A Off-label use (Zulassungsüberschreitende Anwendung eines Arzneimittels): [---]* Page 2 of 7

3 Primary Outcome - Safety: absolute and relative incidence of adverse events; time frame: entire study - Efficacy: best response, progression-free survival, overall survival; time frame: entire study Secondary Outcome - Safety: absolute and relative incidence of therapy interruption; time frame: entire study Countries of recruitment DE Germany Locations of Recruitment Dr. med. Harald Held, Neumuenster Dr. med. Hans Wilhelm Duebbers, Ahaus Dr. Ludwig Fischer von Weikersthal, Amberg Studienzentrum Drs. Klausmann / Dr. Welslau, Haematologie-Onkologie-Diabetologie, Aschaffenburg Carsten Lange, Bernburg Dr. Jens-Uwe Krieger, Chemnitz Zeisigwaldklinikum Bethanien Chemnitz, Chemnitz Leonhard Stark, Deggendorf Prof. Dr. med. Udo Rebmann, Dessau Dr.med Johannes Mohm, Dresden Dr. med. Ralf Eckert, Eisleben Goebell, Erlangen Prof. Dr. med. Lothar Bergmann, Frankfurt am Main Dr. med. Gunter Derigs, Frankfurt am Main Hoffkes, Fulda PD Dr. Uwe Zimmermann, Greifswald Internistische Gemeinschaftspraxis, Guestrow Dr. med. Arne Strauss, Göttingen Page 3 of 7

4 Dr. med. Michael Rink, Hamburg Dr. med. Hanns-Detlev Harich, Hof Universitaetsklinikum des Saarlandes, Klinik fuer Urologie und Kinderurologie, Homburg/Saar Dr. med. Susan Foller, Jena Steinmetz, Koeln Klinisches Studienzentrum Urlogie, Koeln Dr. med. Martina Stauch, Kronach Dr. med. Ursula Vehling-Kaiser, Landshut Dr. Andreas Kohler, Langen Dietel, Leipzig Andreas Schwarzer, Leipzig Lutz Kamann, Leipzig Dr.med. Matthias Schulze, Markkleeberg Dr. med. Jan Klaus Schroder, Mulheim Dr.med. Wolfgang Abenhardt, München Herrmann, Münster Dr. med. Thomas Gehring, Neckarsulm Dres. Derouet Poenicke Becker, Neunkirchen Physician for Internal Medicine, Neuwied Dr. med. David Kunst, Nienburg Dr.med. Christian Linder, Nordhausen Dr. med. Joachim Zimber, Nürnberg Ralf-Bodo Kühn, Oldenburg Wolfgang Marz, Osnabruck Dr. med. Torsten Geyer, Ostfildern Dr. med. Ino Kietz, Parchim Office of Friedrich Overkamp, Oncologia Nova, Recklinghausen Andreas Hübner, Rostock Diakonie-Klinikum ggmbh, Schwäbisch Hall Dr. med. Thomas Geer, Schwäbisch Hall Office of Judith Franz-Werner, Speyer Dr. Matthias Groschek, Stolberg Page 4 of 7

5 Dr. med. Heinz Kirchen, Trier Klinik für Urologie, Eberhard-Karls-Universitaet Tuebingen,, Tuebingen Klotz, Weiden Dr.med. Jan Janssen, Westerstede Universitaetsklinik Wuerzburg, Medizinische Poliklinik, Wuerzburg Jochen Gleissner, Wuppertal Mathias Schulze, Zittau Scheffler, Zwickau Recruitment Planned/Actual: [---]* (Anticipated or Actual) Date of First Enrollment: 2013/01/31 Target Sample Size: 1600 Monocenter/Multicenter trial: Multicenter trial National/International: [---]* Inclusion Criteria Gender: Both, male and female Minimum Age: 18 Years Maximum Age: 99 Years Additional Inclusion Criteria - Patients with proven tumor of RCC, MCL or GIST by histology. - Informed consent signed by patient. Exclusion criteria - Pregnancy Addresses Page 5 of 7

6 Primary Sponsor Pfizer Telephone: [---]* Contact for Scientific Queries Pfizer Pfizer CT.gov Call Center Telephone: [---]* Contact for Public Queries Pfizer CT.gov Call Center Telephone: Sources of Monetary or Material Support [---]* Bitte wenden Sie sich an den Sponsor / Please refer to primary sponsor Telephone: [---]* Status Recruitment Status: Recruiting ongoing Study Closing (LPLV): [---]* Trial Publications, Results and other documents Further trial documents To obtain contact information for a study center near you, click here. Page 6 of 7

7 The parameters in ClinicalTrials.gov and DRKS are not identical. Therefore the data import from ClinicalTrials.gov required adjustments. For full details please see the DRKS FAQs. - Translation on version: 8 - Last processed date by ClinicalTrials.gov: 2016/01/14 Please note: There are additional attributes available concerning this trial. To open an extended view please click here.