check_circleStudy Completed
Melanoma
Bayer Identifier:
11718
ClinicalTrials.gov Identifier:
EudraCT Number:
EU CT Number:
Not Available
A Treatment Combination for Patients with Unresectable Stage III or Stage IV Melanoma
Trial purpose
The objectives of this study are to compare the anti-tumor activity as measured by Progression Free Survival (PFS) and tolerability of Sorafenib in combination with Paclitaxel and Carboplatin versus Paclitaxel and Carboplatin in combination with placebo in subjects with unresectable Stage III or Stage IV melanoma who progressed after receiving only one prior therapy containing Dacarbazine (DTIC) or Temozolomide (TMZ).
Key Participants Requirements
Sex
BothAge
18 YearsTrial summary
Enrollment Goal
270Trial Dates
May 2005 - January 2009Phase
Phase 3Could I Receive a placebo
YesProducts
Nexavar (Sorafenib, BAY43-9006)Accepts Healthy Volunteer
NoWhere to participate
Status | Institution | Location |
---|---|---|
Completed | Klinikum der Eberhard-Karls-Universität Tübingen | Tübingen, 72076, Germany |
Completed | Klinikum der Christian-Albrechts-Universität | Kiel, 24105, Germany |
Completed | Krankenhaus Nordwest | Frankfurt, 60488, Germany |
Completed | Klinikum Mannheim gGmbH | Mannheim, 68135, Germany |
Completed | Royal Marsden Hospital (London) | London, SW3 6JJ, United Kingdom |
Terminated | Guy's Hospital | London, SE1 9RT, United Kingdom |
Completed | Christie Hospital | Manchester, M20 4BX, United Kingdom |
Terminated | Clatterbridge Centre for Oncology | Bebington, CH63 4JY, United Kingdom |
Completed | Southampton General Hospital | Southampton, SO16 6YD, United Kingdom |
Completed | Nottingham City Hospital | Nottingham, NG5 1PB, United Kingdom |
Completed | Singleton Hospital | Swansea, SA2 8QA, United Kingdom |
Completed | Royal Marsden NHS Trust (Surrey) | Sutton, SM2 5PT, United Kingdom |
Completed | University of Pittsburgh Medical Center Health System | Pittsburgh, 15232, United States |
Completed | University of Arizona Cancer Center | Tucson, 85724, United States |
Completed | Nebraska Methodist Hospital | Omaha, 68114, United States |
Completed | Office of Dr. Sewa Legha, MD | Houston, 77030, United States |
Terminated | University of Alabama at Birmingham | Birmingham, 35243, United States |
Completed | University of Virginia Health System | Charlottesville, 22908, United States |
Completed | Washington University School of Medicine | St. Louis, 63110, United States |
Completed | University of Louisville | Louisville, 40202, United States |
Terminated | Rush University Medical Center | Chicago, 60612, United States |
Completed | Mountainside Hospital | Montclair, 07042, United States |
Terminated | Oncology Specialists, SC | Park Ridge, 60068, United States |
Terminated | Advocate Lutheran General Hospital | Park Ridge, 60068, United States |
Completed | Hôpital Ambroise Paré - Boulogne Billancourt | BOULOGNE-BILLANCOURT, 92104, France |
Completed | Institut Gustave Roussy - Villejuif | VILLEJUIF, 94805, France |
Terminated | Hôpital de la Pitié-Salpétrière - Paris | PARIS, 75634, France |
Terminated | Krankenanstalt Mutterhaus der Borromaerinnen | Trier, 54290, Germany |
Completed | Klinikum der Johann Wolfgang Goethe Universität Frankfurt | Frankfurt, 60590, Germany |
Completed | Universitätsklinikum Essen | Essen, 45122, Germany |
Completed | Charité Campus Benjamin Franklin | Berlin, 12200, Germany |
Completed | Universitätsklinikum Heidelberg | Heidelberg, 69112, Germany |
Completed | Klinikum rechts der Isar | München, 81675, Germany |
Completed | Universitätsklinikum des Saarlandes | Homburg, 66421, Germany |
Completed | Leicester Royal Infirmary | Leicester, LE1 5WW, United Kingdom |
Completed | St James' University Hospital | Leeds, LS9 7TF, United Kingdom |
Completed | Vanderbilt University Medical School | Nashville, 37232-6307, United States |
Completed | Memorial Sloan-Kettering Cancer Center | New York, 10065, United States |
Completed | The Angeles Clinic & Research Institute | Los Angeles, 90025, United States |
Completed | James Care - Kenny Road | Columbus, 43221, United States |
Completed | Hôpital Saint André - Bordeaux | BORDEAUX, 33000, France |
Completed | Sir Mortimer B. Davis Jewish General Hospital | Montreal, H3T 1E2, Canada |
Completed | Erasmus MC Daniel den Hoed | ROTTERDAM, 3075 EA, Netherlands |
Completed | Nederlands Kanker Instituut | AMSTERDAM, 1066 CX, Netherlands |
Completed | Cabrini Medical Centre | Malvern, 3144, Australia |
Terminated | Royal Prince Alfred Hospital | Camperdown, 2050, Australia |
Completed | The Alfred Hospital | Melbourne, 3004, Australia |
Completed | Newcastle Mater Misericordiae Hospital | Warartah, 2300, Australia |
Terminated | Sir Charles Gairdner Hospital | Nedlands, 6009, Australia |
Completed | University of South Florida | Tampa, 33612, United States |
Completed | University of Colorado Health Sciences Center | Aurora, 80045, United States |
Completed | Seattle Cancer Care Alliance | Seattle, 98109-1023, United States |
Completed | Roswell Park Cancer Institute | Buffalo, 14263, United States |
Terminated | Centre Val d'Aurelle - Montpellier | MONTPELLIER CEDEX, 34298, France |
Completed | Hôpital Saint Louis - Paris | PARIS, 75010, France |
Completed | Hôpital Morvan - Brest | BREST, 29285, France |
Completed | Centre Léon Bérard | LYON CEDEX, 39373, France |
Completed | Cross Cancer Institute | Edmonton, T6G 1Z2, Canada |
Completed | Princess Margaret Hospital-University Health Network | Toronto, M5G 2M9, Canada |
Completed | London Regional Cancer Program | London, N6A 4L6, Canada |
Completed | Tom Baker Cancer Centre | Calgary, T2N 4N2, Canada |
Completed | Sunnybrook Health Sciences Centre | Toronto, M4N 3M5, Canada |
Terminated | University Medical Center Utrecht | UTRECHT, 3584 CX, Netherlands |
Completed | Austin Health | Heidelberg, 3084, Australia |
Completed | Westmead Hospital | Westmead, 2145, Australia |
Completed | Brisbane Mater Misericordiae Hospital | Brisbane, 4101, Australia |
Completed | Peter MacCallum Cancer Institute | East Melbourne, 3002, Australia |
Primary Outcome
- Progression Free Survival (PFS)date_rangeTime Frame:Time from randomization to documented tumor progression or death (median time of 124 days)enhanced_encryptionNoSafety Issue:
Secondary Outcome
- Overall Survival (OS)date_rangeTime Frame:Time from randomization to death (median time of 294 days)enhanced_encryptionNoSafety Issue:
- Time to Progression (TTP)date_rangeTime Frame:Time from randomization to documented tumor progression (median time of 126 days)enhanced_encryptionNoSafety Issue:
- Duration of Response (DOR)date_rangeTime Frame:Time from initial response to documented tumor progression or death (median time of 197 days)enhanced_encryptionNoSafety Issue:
- Change From Baseline in Eastern Cooperative Oncology Group (ECOG) Performance Status to the Visit When the Best Tumor Response Was Noteddate_rangeTime Frame:baseline and at visit when best response was noted (maximum treatment duration of 68.3 weeks)enhanced_encryptionNoSafety Issue:
Trial design
Trial Type
InterventionalIntervention Type
DrugTrial Purpose
TreatmentAllocation
RandomizedBlinding
Double BlindAssignment
Parallel AssignmentTrial Arms
2Additional Information
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