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Phase III Sequential Open-label Study to Evaluate the Efficacy and Safety of Sorafenib Followed by Pazopanib Versus Pazopanib Followed by Sorafenib in the Treatment of Advanced / Metastatic Renal Cell Carcinoma (SWITCH-II)

Information source: Technische Universität München
ClinicalTrials.gov processed this data on August 23, 2015
Link to the current ClinicalTrials.gov record.

Condition(s) targeted: Renal Cell Carcinoma

Intervention: Sorafenib+Pazopanib (Drug); Pazopanib+Sorafenib (Drug)

Phase: Phase 3

Status: Recruiting

Sponsored by: Technische Universität München

Official(s) and/or principal investigator(s):
Jürgen E. Gschwend, Prof., Principal Investigator, Affiliation: Klinikum rechts der Isar, TU München

Overall contact:
Stefan Feldner, Dr., Phone: +49(0) 761 / 152 42-19, Email: stefan.feldner@iomedico.com

Summary

Sorafenib and pazopanib are both effective and promising treatments for advanced Renal Cell Carcinoma (RCC). Both drugs are registered for this indication. No prospective comparative data in advanced RCC (or other indications) have been published. A search in the clinicaltrials. gov database did not reveal any planned or ongoing studies. As sequential therapy is now the standard of treatment for advanced RCC it is important to evaluate in clinical trials what the value of different sequential strategies is. This needs to be done every time new agents are introduced into the treatment armamentarium. As there are no data yet on the sequential use of sorafenib followed by pazopanib or vice versa, this sequence, however, will most certainly be used in daily practice, it is required to examine efficacy and safety of this sequential approach in a clinical trial in a randomized setting. Therefore, the investigators have designed an open randomized study in patients not previously treated for advanced RCC. Suitable patients will be randomized (1: 1) in 2 groups.

Clinical Details

Official title: Phase III Randomized Sequential Open-label Study to Evaluate the Efficacy and Safety of Sorafenib Followed by Pazopanib Versus Pazopanib Followed by Sorafenib in the Treatment of Advanced / Metastatic Renal Cell Carcinoma

Study design: Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Primary outcome: To evaluate if progression-free survival from randomization to progression or death during second-line therapy (Total PFS) of sorafenib followed by pazopanib is non-inferior compared to pazopanib followed by sorafenib.

Secondary outcome:

Time from randomization to progression during second-line therapy (total TTP)

Time to first-line treatment failure (progression, death, discontinuation due to toxicity) descriptively in each arm

PFS in first-line and second-line treatment, descriptively

Overall survival, descriptively (data cut-off same as for primary endpoint

Disease Control Rate (DCR); Response rates in first-line and in second-line (CR, PR, SD according to RECIST criteria)

Health-related Quality of Life (FACIT-F, FKSI-10)

Biomarker programme

Safety and tolerability

Eligibility

Minimum age: 18 Years. Maximum age: 85 Years. Gender(s): Both.

Criteria:

Inclusion Criteria: 1. Patients with metastatic / advanced RCC (all histologies), who are not suitable for cytokine therapy and for whom study medication constitutes first-line treatment. For cytokine- unsuitability at least one of the following criteria must be fulfilled*:

- Age 66 to 88 years

- Non-clear cell histology RCC

- Intermediate risk according to MSKCC score

- ECOG ≥ 1 and> 1 organ metastasis + < 24 months between diagnosis and

establishing indication for interleukin-2-therapy

- ECOG ≥ 1 and "unable to carry on normal activity or do active work" (Karnofsky

Index 70%)

- Creatinine ≥ 1x ULN and < 2x ULN

- Total bilirubin ≥ 1x ULN and < 1. 5x ULN

- Present autoimmune disease

- Patients who might require steroids

- Hypersensitivity against cytokines

- Severe organic disease, not interfering with other in-/exclusion criteria of the

Switch-2 study

- Non-symptomatic brain metastases

- Severe lung disease (e. g. PAH, COPD) with Pa O2 < 60 mmHg on rest

2. Age ≥ 18 and ≤ 85 years 3. Karnofsky Index ≥ 70% (see appendix 15. 1) 4. MSKCC prognostic score (2004), low or intermediate (see appendix 15. 2) 5. Life expectancy of at least 12 weeks 6. Subjects with at least one uni-dimensional (for RECIST 1. 1) measurable lesion. Lesions must be measured by CT/MRI- scan 7. Adequate bone marrow, liver and renal function as assessed by the following laboratory requirements to be conducted within 7 days prior to start of therapy:

- hemoglobin > 9. 0 g/dl

- absolute neutrophil count (ANC) > 1,500 µl

- Platelet count ≥ 100,000 / µl

- total bilirubin < 1. 5x the upper limit of normal (Note: Subjects with Gilbert'

Syndrome are eligible if their total bilirubin is < 3. 0 X ULN and direct bilirubin ≤ 35 %).

- ALAT and ASAT < 2. 5x upper limit of normal (Note: concomitant elevations in

bilirubin ans ASAT/ALAT above 1. 0x upper limit of normal are not permitted).

- Alkaline phosphatase < 4x upper limit of normal

- PT-INR/aPTT < 1. 2x upper limit of normal (Patients who are being therapeutically

anticoagulated with an agent such as coumadin or heparin will be allowed to participate provided that their INR is stable and within the recommended range for the desired level of anticoagulation and no prior evidence of underlying abnormality in these parameters exists).

- Serum creatinine < 2x upper limit of normal

8. Written Informed Consent Exclusion Criteria: 1. History of cardiac disease: congestive heart failure > NYHA class 2 or with LVEF at baseline echocardiography < 50%, (echocardiography is optional); active CAD (MI more than 6 months prior to study entry is allowed); cardiac arrhythmias requiring anti-arrhythmic therapy (beta blockers or digoxin are permitted) 2. Uncontrolled hypertension (defined as blood pressure ≥ 150 mmHg systolic and/or ≥ 90 mmHg diastolic on medication). 3. History of HIV infection or chronic hepatitis B or C 4. 4. Active clinically serious infections (> grade 2 NCI-CTC version 4. 03) 5. Symptomatic metastatic brain or meningeal tumors (unless the patient is > 6 months from definitive therapy, has a negative imaging study within 4 weeks of study entry and is clinically stable with respect to the tumor at the time of study entry) 6. Patients with seizure disorder requiring medication (such as steroids or anti-epileptics) 7. Patients with evidence or history of bleeding diathesis 8. History of organ allograft 9. Major surgery within 4 weeks of start of study 10. Autologous bone marrow transplant or stem cell rescue within 4 months before study start. 11. Any significant condition that increases the risk for bleeding, including, but not limited to active peptic ulcer disease, inflammatory bowel disease, known intraluminal or endobronchial metastatic lesions and/or lesions infiltrating major pulmonary vessels with risk of bleeding, presence of non-healing wound or trauma within 4 weeks prior to first dose of investigational drug 12. History of cerebrovascular accident including transient ischemic attack (TIA), pulmonary embolism or untreated deep vein thrombosis (DVT) within the past 6 months (Note: Subjects with recent DVT who have been treated with therapeutic anti-coagulating agents for at least 6 weeks are eligible) 13. Corrected QT Interval (QTc) > 480 msecs 14. Untreated hypothyroidism 15. Patients undergoing renal dialysis 16. Previous or concurrent cancer that is distinct in primary site or histology from the cancer being evaluated in this study EXCEPT cervical carcinoma in situ, treated basal cell carcinoma, superficial bladder tumors [Ta, Tis & T1] or any cancer curatively treated > 3 years prior to study entry 17. Pregnant or breast-feeding patients. Women of childbearing potential must have a negative pregnancy test performed within 7 days of the start of treatment. Both men and women enrolled in this trial must use adequate barrier birth control measures (with a Pearl Index < 1) during the course of the trial and 3 months after the completion of trial 18. Substance abuse, medical, psychological or social conditions that may interfere with the patient's participation in the study or evaluation of the study results 19. Any condition that is unstable or could jeopardize the safety of the patient and their compliance in the study 20. Patients unable to swallow oral medications 21. Clinically significant gastrointestinal abnormalities that may affect absorption of investigational product 22. Known allergy to Votrient or Nexavar (i. e. to active substance or one of the constituents) 23. Prior exposure to study drugs. 24. Investigational drug therapy within 4 weeks of study entry. 25. Use of biologic response modifiers, such as G-CSF and other hematopoietic growth factors, within 3 weeks of study entry 26. Radiotherapy within 3 weeks of start of study drug and planned radiotherapy during the study 27. Concomitant medication: Any condition at the discretion of the investigator that precludes compliance with concomitant therapy restrictions described below.

Locations and Contacts

Stefan Feldner, Dr., Phone: +49(0) 761 / 152 42-19, Email: stefan.feldner@iomedico.com

Medizinische Universität Innsbruck, Innsbruck 6020, Austria; Completed

A. ö. Bezirkskrankenhaus Kufstein, Kufstein 6330, Austria; Recruiting
Email: lorenz.hoeltl@bkh-kufstein.at
Lorenz Höltl, Dr., Principal Investigator

AKH Linz GmbH, Linz 4020, Austria; Recruiting
Email: steffen.krause@akh.linz.at
Steffen Krause, Dr., Principal Investigator

LKH Salzburg, Salzburg 5020, Austria; Recruiting
Email: g.janetschek@salk.at
Günter Janetschek, Prof. Dr., Principal Investigator

Universitätsklinikum Aachen, Urologische Klinik, Aachen 51074, Germany; Recruiting
Email: bbrehmer@ukaachen.de
Bernhard Brehmer, Dr., Principal Investigator

Gesundheitszentrum St. Marien GmbH, Amberg 92224, Germany; Recruiting
Email: weikersthal.ludwig@gesundheitszentrum.klinikum-amberg.de
Ludwig Fischer von Weikersthal, Dr., Principal Investigator

Charite Campus Virchow Klinikum / Klein. Für Innere Med / Onkologie/Hämatologie, Berlin 13353, Germany; Recruiting
Email: jorg.westermann@charite.de
Jörg Westermann, Dr., Principal Investigator

Praxis für Urologie, Berlin 13055, Germany; Recruiting
Email: dr.wolfgang.hoelzer@gmx.de
Wolfgang Hölzer, Dr., Principal Investigator

Gemeinschaftspraxis Pott / Tirier / Hannig - Onkologie, Bottrop 46236, Germany; Recruiting
Email: c.hannig@email.de
Carla V Hannig, Dr., Principal Investigator

Urologie im Schlosscarrée Braunschweig, Braunschweig 38100, Germany; Recruiting
Email: Junius@urologie-schlosscarree.de
Harald Junius, Dr., Principal Investigator

Klinikum Bremen-Mitte gGmbH, Bremen 28177, Germany; Completed

Bethanien Krankenhaus Chemnitz gGmbH, Chemnitz 09130, Germany; Recruiting
Email: h.belz@bethanien-sachsen.de
Hanjo Belz, Dr., Principal Investigator

Onkologische Gemeinschaftspraxis Dörfel/Göhler, Dresden 01127, Germany; Recruiting
Email: thomas.goehler@dgn.de
Thomas Göhler, Dr., Principal Investigator

Universitätsklinikum Carl Gustav Carus der Technischen Universität Dresden, Dresden 01307, Germany; Recruiting
Email: manfred.wirth@uniklinikum-dresden.de
Manfred Wirth, Prof. Dr., Principal Investigator

Urologische Gemeinschaftspraxis, Duisburg 47179, Germany; Recruiting
Email: hellmis@urologo.de
Eva Hellmis, Dr., Principal Investigator

Krankenhaus Düren gGmbH, Düren 52351, Germany; Not yet recruiting
Email: christof.boergermann@krankenhaus-dueren.de
Christof Börgermann, Dr., Principal Investigator

Universitätsklinikum Düsseldorf, Düsseldorf 40225, Germany; Recruiting
Email: markus.giessing@med.uni-duesseldorf.de
Markus Giessing, Dr., Principal Investigator

Urologie Neandertal - Ortsübergreifende Gemeinschaftspraxis für Urologie, Erkrath 40699, Germany; Completed

Waldkrankenhaus St. Marien, Erlangen 91054, Germany; Recruiting
Email: peter.goebell@uk-erlangen.de
Peter J Goebell, Dr., Principal Investigator

St.-Antonius-Hospital in Eschweiler / Klinik f. Hämatologie und Onkologie, Eschweiler 52249, Germany; Recruiting
Email: onk@sah-eschweiler.de
Peter Staib, Dr., Principal Investigator

Hämato-onkologische Gemeinschaftspraxis, Essen 45136, Germany; Recruiting
Email: praxis@onkologie-essen.de
Ulla Frfr. von Verschuer, Dr., Principal Investigator

Onkozentrum Freiberg, Freiberg 09599, Germany; Not yet recruiting
Email: boldt@onkozentrum.de
Thomas Boldt, Principal Investigator

Praxis für interdisziplinäre Onkologie & Hämatologie, Freiburg 79106, Germany; Recruiting
Email: zaiss@onkologie-freiburg.de
Matthias Zaiss, Dr., Principal Investigator

Universitätsklinikum Freiburg, Freiburg 79106, Germany; Recruiting
Email: christian.leiber@uniklinik-freiburg.de
Christian Leiber, Dr., Principal Investigator

MVZ Osthessen GmbH, Fulda 36043, Germany; Recruiting
Email: Silke.Schirrmacher-Memmel@klinikum-fulda.de
Silke Schirrmacher-Memmel, Dr., Principal Investigator

Gem.praxis Dres. J. Wilke, H. Wagner - Hämatol.u.intern.Onkol. am Klinikum Fürth, Fürth 90766, Germany; Not yet recruiting
Email: info@onkologie-fuerth.de
Jochen Wilke, Dr., Principal Investigator

Onkologische Schwerpunktpraxis, Goslar 38642, Germany; Recruiting
Email: studien@onkologie-goslar.de
Hans W Tessen, Dr., Principal Investigator

Universitätsmedizin Greifswald, Greifswald 17475, Germany; Recruiting
Email: ziuro@uni-greifswald.de
Uwe Zimmermann, Dr., Principal Investigator

St. Antonius-Hospital Gronau GmbH, Gronau 48599, Germany; Recruiting
Email: witt@st-antonius-gronau.de
Jörn Witt, Dr., Principal Investigator

Universitätsklinikum Göttingen, Göttingen 37075, Germany; Recruiting
Email: astrauss@med.uni-goettingen.de
Arne Strauß, Dr., Principal Investigator

Asklepios Klinik Altona, Hamburg 22763, Germany; Recruiting
Email: c.wuelfing@asklepios.com
Christian Wülfing, Prof. Dr., Principal Investigator

Onkologische Schwerpunktpraxis, Hamburg 20095, Germany; Recruiting
Email: jwierecky@gmx.de
Jan Wierecky, Dr., Principal Investigator

Universitätsklinikum Heidelberg, Klinik für Urologie, Heidelberg 69120, Germany; Recruiting
Email: sascha.pahernik@med.uni-heidelberg.de
Sascha Pahernik, Dr., Principal Investigator

Urologie-Heinsberg, Heinsberg 52525, Germany; Recruiting
Email: kretz@urologie-heinsberg.de
Thomas Kretz, Principal Investigator

Onkologische Praxis, Hildesheim 331135, Germany; Recruiting
Email: dr.freier@onkologie-hildesheim.de
Werner Freier, Dr., Principal Investigator

Universitätsklinikum des Saarlandes, Homburg 66421, Germany; Recruiting
Email: Carsten.Ohlmann@uks.eu
Carsten-Henning Ohlmann, Dr., Principal Investigator

Universitätsklinikum Jena, Klinik für Urologie, Jena 07743, Germany; Recruiting
Email: marc-oliver.grimm@med.uni-jena.de
Marc O Grimm, Prof., Principal Investigator

Überörtliche Gemeinschaftspraxis, Köln 50968, Germany; Not yet recruiting
Email: info@drklier.de
Jörg Klier, Dr., Principal Investigator

Praxis für Urologie, Lauenburg 21481, Germany; Not yet recruiting
Email: Dr.Simson@t-online.de
Gabriele Simson, Dr., Principal Investigator

Onkologische Schwerpunktpraxis Leer - Emden, Leer 26789, Germany; Recruiting
Email: lothar.mueller@onkologie-leer.de
Lothar Müller, Dr., Principal Investigator

MVZ Mitte/ MVZ Delitzsch GmbH, Leipzig 04103, Germany; Completed

Urologische Facharztpraxis, Lutherstadt Eisleben 06295, Germany; Recruiting
Email: R.Eckert@onlinemed.de
Ralf Eckert, Dr., Principal Investigator

Universitätsklinikum Magdeburg A.ö.R, Magdeburg 39120, Germany; Recruiting
Email: martin.schostak@med.ovgu.de
Martin Schostak, Prof. Dr., Principal Investigator

Universitätsklinik Mannheim, Mannheim 68167, Germany; Recruiting
Email: christian.bolenz@medma.uni-heidelberg.de

Philips-Universität-Marburg, Urologie und Kinderurologie, Marburg 35043, Germany; Recruiting
Email: Hegele@med.uni-marburg.de
Axel Hegele, Dr., Principal Investigator

Praxis Markkleeberg, Markkleeberg 04416, Germany; Not yet recruiting
Email: m.schulze@praxis-schulze.de
Matthias Schulze, Dr., Principal Investigator

Kliniken Maria Hilf, Mönchengladbach 41063, Germany; Not yet recruiting
Email: herbert.sperling@mariahilf.de
Herbert Sperling, Prof. Dr., Principal Investigator

PUR/R Praxisklinik Urologie Rhein Rhur, Mühlheim 45458, Germany; Not yet recruiting
Email: a.eisenhardt@pur-r.de
Andreas Eisenhardt, Dr., Principal Investigator

Klinikum r. d. Isar, Klinik für Urologie, München 81675, Germany; Recruiting
Margitta Retz, Dr., Email: Margitta.Retz@lrz.tu-muenchen.de
Margitta Retz, Dr., Principal Investigator

Universitätsklinikum Münster , Klinik für Urologie, Münster 48149, Germany; Recruiting
Email: Edwin.Herrmann@ukmuenster.de
Edwin Herrmann, Dr., Principal Investigator

Eps- early phase solutions GmbH, Pößneck, Germany; Not yet recruiting
Email: klaus.ruffert@eps-earlyphase.com
Klaus Ruffert, Dr., Principal Investigator

Caritas Krankenhaus St. Josef, Regensburg 93053, Germany; Recruiting
Email: sdenzinger@gmx.de
Stefan Denzinger, Dr., Principal Investigator

Universitätsklinikum Rostock, Rostock 18055, Germany; Recruiting
Email: oliver.hakenberg@med.uni-rostock.de
Oliver Hakenberg, Prof. Dr., Principal Investigator

Zentrum für Urologie und Onkologie, Rostock 18107, Germany; Recruiting
Andreas Huebner, Dr., Principal Investigator

Diakoniekrankenhaus Rotenburg (Wümme) gGmbH, Rotenburg (Wümme) 27356, Germany; Not yet recruiting
Email: muschter@diako-online.de
Rolf Muschter, Prof. Dr., Principal Investigator

Klinikum Sindelfingen-Böblingen, Sindelfingen 71065, Germany; Recruiting
Email: t.knoll@klinikverbund-suedwest.de
Thomas Knoll, Prof. Dr., Principal Investigator

Marienhospital / Innere Med III Onko Hämato Palliativm, Stuttgart 70199, Germany; Recruiting
Email: ClaudioDenzlinger@vinzenz.de
Claudio Denzlinger, Prof., Principal Investigator

Eberhard-Karls-Universität Tübingen, Tübingen 72076, Germany; Recruiting
Email: bedke@live.com
Jens Bedke, Dr., Principal Investigator

Universitätsklinik Ulm, Ulm 89075, Germany; Recruiting
Email: thomas.schnoeller@uniklinik-ulm.de
Thomas Schnöller, Dr., Principal Investigator

Universitätsklinikum Ulm, Ulm 89081, Germany; Recruiting
Email: jochen.greiner@uniklinik-ulm.de
Jochen Greiner, Prof. Dr., Principal Investigator

Praxis für Hämatologie und internistische Onkologie, Velbert 42551, Germany; Not yet recruiting
Email: nusch@aol.com
Arnd Nusch, Dr., Principal Investigator

Klinikum Nordoberpfalz AG, Weiden 92637, Germany; Not yet recruiting
Email: theodor.klotz@kliniken-nordoberpfalz.ag
Theodor Klotz, Prof. Dr., Principal Investigator

Gesellsch. z. Förd. Von Wissenschaft u.Qualitätssicherung i.d.ambul.Onkologie, Wiesbaden 65191, Germany; Recruiting
Email: josten.haema-onko@dkd-wiesbaden.de
Klaus M Josten, Dr., Principal Investigator

Praxisgemeinschaft für Onkologie und Urologie, Wilhelmshaven 26389, Germany; Recruiting
Email: yrodemer@yahoo.com
Yolanda Rodemer, Principal Investigator

Gemeinschaftspraxis für Urologie, Wuppertal 42103, Germany; Recruiting
Email: jgleissner@dgu-team.de
Jochen Gleißner, Dr., Principal Investigator

Universitätsklinikum Würzburg, Würzburg 97080, Germany; Recruiting
Email: burger_m2@klinik.uni-wuerzburg.de
Maximilian Burger, Dr., Principal Investigator

Onze Lieve Vrouwe Gasthuis, Amsterdam 1091 HA, Netherlands; Recruiting
Email: j.m.meerumterwogt@olvg.nl
Jetske M Meerum Terwogt, Principal Investigator

Reinier de Graaf Gasthuis, Delft 2600 AG, Netherlands; Recruiting
Email: bos@rdgg.nl
Monique M.E.M. Bos, Principal Investigator

HAGA, Den Haag 2545, Netherlands; Recruiting
Houtsma, Dr., Principal Investigator

Spaarne Ziekenhuis, Hoofddorp 2130 AT, Netherlands; Recruiting
Email: abeeker@spaarneziekenhuis.nl
Aart Beeker, Dr., Principal Investigator

TweeSteden Ziekenhuis, Tilburg 5042 AD, Netherlands; Recruiting
Email: sgoey@tsz.nl
Swan H Goey, Dr., Principal Investigator

VieCuri Medical Center, Venlo 5912 BL, Netherlands; Recruiting
Email: yvdwouw@viecuri.nl
Agnes J van de Wouw, Dr., Principal Investigator

Additional Information

Starting date: May 2012
Last updated: January 19, 2015

Page last updated: August 23, 2015

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