Trial Condition(s):
Melanoma
A Treatment Combination for Patients with Unresectable Stage III or Stage IV Melanoma
Bayer Identifier:
11718
ClinicalTrials.gov Identifier:
EudraCT Number:
EU CT Number:
Not Available
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).
Inclusion Criteria
- Subjects who have a life expectancy of at least 12 weeks - Subjects with histologically or cytologically confirmed unresectable (Stage III) or metastatic (Stage IV) melanoma - Subjects must have progressed after receiving at least one cycle of DTIC or TMZ containing regimen - Subjects who have an ECOG PS of 0 or 1 - Measurable disease defined as at least one lesion that can be accurately and serially measured per the modified RECIST criteria
Exclusion Criteria
- Primary ocular or mucosal melanoma - 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 [Noninvasive papillary carcinoma], Tis [Carcinoma in situ: "flat tumor"]& T1 [Tumor invades subepithelial connective tissue]) or any cancer curatively treated < 5 years prior to study entry - History of cardiac disease - Known history of human immunodeficiency virus (HIV) infection
Trial Summary
Enrollment Goal
Trial Dates
Phase
Could I receive a placebo?
Products
Accepts Healthy Volunteers
Where to Participate
| Locations | Status | |
|---|---|---|
Locations Klinikum der Eberhard-Karls-Universität Tübingen Tübingen, Germany, 72076 | Status Completed | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Klinikum der Christian-Albrechts-Universität Kiel, Germany, 24105 | Status Completed | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Krankenhaus Nordwest Frankfurt, Germany, 60488 | Status Completed | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Klinikum Mannheim gGmbH Mannheim, Germany, 68135 | Status Completed | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Royal Marsden Hospital (London) London, United Kingdom, SW3 6JJ | Status Completed | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Guy's Hospital London, United Kingdom, SE1 9RT | Status Terminated | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Christie Hospital Manchester, United Kingdom, M20 4BX | Status Completed | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Clatterbridge Centre for Oncology Bebington, United Kingdom, CH63 4JY | Status Terminated | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Southampton General Hospital Southampton, United Kingdom, SO16 6YD | Status Completed | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Nottingham City Hospital Nottingham, United Kingdom, NG5 1PB | Status Completed | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Singleton Hospital Swansea, United Kingdom, SA2 8QA | Status Completed | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Royal Marsden NHS Trust (Surrey) Sutton, United Kingdom, SM2 5PT | Status Completed | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations University of Pittsburgh Medical Center Health System Pittsburgh, United States, 15232 | Status Completed | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations University of Arizona Cancer Center Tucson, United States, 85724 | Status Completed | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Nebraska Methodist Hospital Omaha, United States, 68114 | Status Completed | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Office of Dr. Sewa Legha, MD Houston, United States, 77030 | Status Completed | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations University of Alabama at Birmingham Birmingham, United States, 35243 | Status Terminated | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations University of Virginia Health System Charlottesville, United States, 22908 | Status Completed | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Washington University School of Medicine St. Louis, United States, 63110 | Status Completed | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations University of Louisville Louisville, United States, 40202 | Status Completed | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Rush University Medical Center Chicago, United States, 60612 | Status Terminated | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Mountainside Hospital Montclair, United States, 07042 | Status Completed | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Oncology Specialists, SC Park Ridge, United States, 60068 | Status Terminated | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Advocate Lutheran General Hospital Park Ridge, United States, 60068 | Status Terminated | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Hôpital Ambroise Paré - Boulogne Billancourt BOULOGNE-BILLANCOURT, France, 92104 | Status Completed | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Institut Gustave Roussy - Villejuif VILLEJUIF, France, 94805 | Status Completed | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Hôpital de la Pitié-Salpétrière - Paris PARIS, France, 75634 | Status Terminated | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Krankenanstalt Mutterhaus der Borromaerinnen Trier, Germany, 54290 | Status Terminated | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Klinikum der Johann Wolfgang Goethe Universität Frankfurt Frankfurt, Germany, 60590 | Status Completed | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Universitätsklinikum Essen Essen, Germany, 45122 | Status Completed | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Charité Campus Benjamin Franklin Berlin, Germany, 12200 | Status Completed | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Universitätsklinikum Heidelberg Heidelberg, Germany, 69112 | Status Completed | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Klinikum rechts der Isar München, Germany, 81675 | Status Completed | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Universitätsklinikum des Saarlandes Homburg, Germany, 66421 | Status Completed | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Leicester Royal Infirmary Leicester, United Kingdom, LE1 5WW | Status Completed | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations St James' University Hospital Leeds, United Kingdom, LS9 7TF | Status Completed | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Vanderbilt University Medical School Nashville, United States, 37232-6307 | Status Completed | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Memorial Sloan-Kettering Cancer Center New York, United States, 10065 | Status Completed | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations The Angeles Clinic & Research Institute Los Angeles, United States, 90025 | Status Completed | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations James Care - Kenny Road Columbus, United States, 43221 | Status Completed | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Hôpital Saint André - Bordeaux BORDEAUX, France, 33000 | Status Completed | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Sir Mortimer B. Davis Jewish General Hospital Montreal, Canada, H3T 1E2 | Status Completed | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Erasmus MC Daniel den Hoed ROTTERDAM, Netherlands, 3075 EA | Status Completed | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Nederlands Kanker Instituut AMSTERDAM, Netherlands, 1066 CX | Status Completed | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Cabrini Medical Centre Malvern, Australia, 3144 | Status Completed | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Royal Prince Alfred Hospital Camperdown, Australia, 2050 | Status Terminated | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations The Alfred Hospital Melbourne, Australia, 3004 | Status Completed | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Newcastle Mater Misericordiae Hospital Warartah, Australia, 2300 | Status Completed | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Sir Charles Gairdner Hospital Nedlands, Australia, 6009 | Status Terminated | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations University of South Florida Tampa, United States, 33612 | Status Completed | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations University of Colorado Health Sciences Center Aurora, United States, 80045 | Status Completed | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Seattle Cancer Care Alliance Seattle, United States, 98109-1023 | Status Completed | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Roswell Park Cancer Institute Buffalo, United States, 14263 | Status Completed | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Centre Val d'Aurelle - Montpellier MONTPELLIER CEDEX, France, 34298 | Status Terminated | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Hôpital Saint Louis - Paris PARIS, France, 75010 | Status Completed | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Hôpital Morvan - Brest BREST, France, 29285 | Status Completed | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Centre Léon Bérard LYON CEDEX, France, 39373 | Status Completed | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Cross Cancer Institute Edmonton, Canada, T6G 1Z2 | Status Completed | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Princess Margaret Hospital-University Health Network Toronto, Canada, M5G 2M9 | Status Completed | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations London Regional Cancer Program London, Canada, N6A 4L6 | Status Completed | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Tom Baker Cancer Centre Calgary, Canada, T2N 4N2 | Status Completed | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Sunnybrook Health Sciences Centre Toronto, Canada, M4N 3M5 | Status Completed | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations University Medical Center Utrecht UTRECHT, Netherlands, 3584 CX | Status Terminated | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Austin Health Heidelberg, Australia, 3084 | Status Completed | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Westmead Hospital Westmead, Australia, 2145 | Status Completed | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Brisbane Mater Misericordiae Hospital Brisbane, Australia, 4101 | Status Completed | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Peter MacCallum Cancer Institute East Melbourne, Australia, 3002 | Status Completed | Contact Us: E-mail: [email protected] Phone: Not Available |
Trial Design
Phase III Randomized, Placebo Controlled Study of Sorafenib in Repeated Cycles of 21 Days in Combination with Paclitaxel/Carboplatin Chemotherapy in Subjects with Unresectable Stage III or Stage IV Melanoma.
Trial Type:
Interventional
Intervention Type:
Drug
Trial Purpose:
Treatment
Allocation:
Randomized
Blinding:
Double Blind
Assignment:
Parallel Assignment
Trial Arms:
2
Primary Outcome
- Progression Free Survival (PFS)Timeframe: Time from randomization to documented tumor progression or death (median time of 124 days)
Secondary Outcome
- Overall Survival (OS)Timeframe: Time from randomization to death (median time of 294 days)
- Time to Progression (TTP)Timeframe: Time from randomization to documented tumor progression (median time of 126 days)
- Duration of Response (DOR)Timeframe: Time from initial response to documented tumor progression or death (median time of 197 days)
- Change From Baseline in Eastern Cooperative Oncology Group (ECOG) Performance Status to the Visit When the Best Tumor Response Was NotedTimeframe: baseline and at visit when best response was noted (maximum treatment duration of 68.3 weeks)
Additional Information
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