- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT00864253
A Trial of ABI-007 Versus Dacarbazine in Previously Untreated Patients With Metastatic Malignant Melanoma
An Open-Label, Multicenter, Phase III Trial of ABI-007 vs Dacarbazine in Previously Untreated Patients With Metastatic Malignant Melanoma
Study Overview
Status
Conditions
Intervention / Treatment
Study Type
Enrollment (Actual)
Phase
- Phase 3
Contacts and Locations
Study Locations
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New South Wales
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Port Macquarie, New South Wales, Australia, 2444
- Port Macquarie Base Hospital
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Sydney, New South Wales, Australia, 2065
- Royal North Shore Hospital
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Westmead, New South Wales, Australia, 2145
- Sydney West Cancer Trials Centre/Westmead Hospital
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South Australia
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Adelaide, South Australia, Australia, 5000
- Royal Adelaide Hospital, Department of Medical Oncology
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Tasmania
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Hobart, Tasmania, Australia, 7000
- Royal Hobart Hospital
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Victoria
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Melbourne, Victoria, Australia, 3004
- Alfred Hospital
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Western Australia
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Nedlands Perth, Western Australia, Australia
- Sir Charles Gairdner Hospital
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Perth, Western Australia, Australia, 6000
- Royal Perth Hospital
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Alberta
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Calgary, Alberta, Canada, T2N 4N2
- Tom Baker Cancer Centre
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Edmonton, Alberta, Canada, T6G 1Z2
- Cross Cancer Institute
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British Columbia
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Kelowna, British Columbia, Canada, V1Y 5L3
- BCCA Centre for the Southern Interior
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Kelowna, British Columbia, Canada, V1Y 5L3
- BCCA, Centre for the Southern Interior
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Surrey, British Columbia, Canada, V3V 1Z2
- BC Cancer Agency-Fraser Valley Ctr.
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Vancouver, British Columbia, Canada, V5Z4E6
- BC Cancer Agency-Vancouver
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Victoria, British Columbia, Canada, V8R 6V5
- BC Cancer Agency-Vancouver Island Ctr.
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Ontario
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London, Ontario, Canada, N6A 4L6
- London Regional Cancer Program
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Missiauga, Ontario, Canada, L5M 2N1
- Credit Valley Hospital
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Ottawa, Ontario, Canada, K1H 8L6
- The Ottawa Hospital Regional Cancer Centre
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Toronto, Ontario, Canada, M4N 3M5
- Sunnybrook Health Sciences Centre
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Quebec
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Montreal, Quebec, Canada, H2W 1S6
- McGill University Dept. of Oncology Clinical Research Program
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Bordeaux, France, 33075
- Hopital Saint Andre' CHU de Bordeaux
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Grenoble Cedex 09, France, 38043
- Centre Hospitaller Universitaire de Grenoble
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Lile Cedax, France
- CHRU Hôpital Claude Huriez
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Limoges cedex, France
- Hopital Dypuytren-CHU de Limoges
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Lyon, France
- Centre Leon Berad
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Marseille Cedex 9, France
- Hôpital Sainte Marguerite
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Montepellier Cedex 5, France
- CHU Hopital Saint Eloi
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Montpellier, France, 34298
- Centre Regional Val d' Aurelle Paul Lamarque
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Nice Cedex 3, France, 06200
- Hopital de 1 Archet 2
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Paris, France, 75018
- Hôpital Bichat
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Paris, France
- Groupe hospitalier Cochin-St. Vincent de Paul
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Paris Cedex, France
- Hôpital Saint-Louis
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Villejuif Cedex, France, 94805
- Institut Gustave Roussy (IGR) Centre de Lutte Contre le Canc
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Leipzig, Germany
- Universitaesklinkum Leipzig
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Mainz, Germany
- Universitaetsklinkum Mainz
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BE
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Berlin, BE, Germany, 10117
- Charite Universitaetsmedizin Berlin
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BW
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Heidelber, BW, Germany
- Universitaetsklinkum Heidelberg
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Heidelberg, BW, Germany
- Universitaetsklinkum Heidelberg
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Tuebingen, BW, Germany, 72076
- Universitaetsklinkum Tuebingen
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BY
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Wuerzburg, BY, Germany, 97080
- Universitaetsklinkum Wuerzburg PS
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HH
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Hamburg, HH, Germany
- Universitaetsklinkum Hamburg-Eppendorf
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NI
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Gottington, NI, Germany
- Univeritaetsklinkum Goettingen
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Hannover, NI, Germany, 30625
- Medizinische Hochschuke Hannover
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Northwest
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Bochum, Northwest, Germany, 44791
- St. Josef-Hospital
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Essen, Northwest, Germany
- Universitaetsklinkum Essen
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Koln, Northwest, Germany
- Universitaetklinkum Koeln
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SH
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Keil, SH, Germany, 24105
- Universitaetsklinkum Schegwig-Holstein
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SN
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Dresden, SN, Germany
- Universitaetsklinkum Dresden
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Strasse 35
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Jena, Strasse 35, Germany, 07743
- UniversitawtsklinKum Jena
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Napoli, Italy, 80131
- Ist. Naz. per lo studio e la cura dei tumori G. Pascale
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Pisa, Italy, 56100
- Ospedale S. Chiara
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BA
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Bari, BA, Italy
- Istituto Tumori "Giovanni Paolo II"
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FC
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Meldola, FC, Italy, 47014
- Istituto Scientifico Romagnolo per lo Studio e la Cura dei T
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GE
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Genova, GE, Italy, 16132
- IST-Istituto Nazionale per la Ricera sul Cancro
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MI
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Milano, MI, Italy, 20141
- Istituto Europeo Di Oncologia
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Milano, MI, Italy
- Istituto Nazionale Tumori
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PD
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Padova, PD, Italy, 35128
- IOV-Instituto Oncologico IRCCS
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SI
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Siena, SI, Italy, 53100
- Azienda Ospedaliera Universitaria Sense
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Alkmaar, Netherlands, 1815
- Medisch Centrum Alkmaar
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Amhem, Netherlands, 6800TA
- Rijnstate Ziekenhuis Arnhem
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Rotterdam, Netherlands
- Erasmus MC ae" Daniel den Hoed
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Barcelona, Spain
- H Clinic i Provincial
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Barcelona, Spain, 08036
- H Clinic i Provincial
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Madrid, Spain
- H Clinico San Carlos
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Sabadell, Spain, 08208
- Corporacion Sanitaria Parc Tauli
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London, United Kingdom, SW3 6JJ
- Royal Marsden Hospital London
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Essex
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Chelmsford, Essex, United Kingdom, CM1 7ET
- Broomfield Hospital
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GT Lon
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London, GT Lon, United Kingdom, SW12 ORE
- St. George's Hospital
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Glam
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Cardiff, Glam, United Kingdom, CF14 2TL
- Velindre Hospital
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Nott
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Nottingham, Nott, United Kingdom, NG5 1PB
- Nottingham University Hospitals NHS Trust
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S Glam
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Swansea, S Glam, United Kingdom, SA28QA
- Singleton Hospital, Sothwest Wales Inst.
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Staffs
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Stroke On Kent, Staffs, United Kingdom, ST4 6QB
- Univ Hospital of North Staffordshire
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Syorks
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Sheffield, Syorks, United Kingdom, S10 2SJ
- Weston Park Hospital
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Wstmid
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Wolverhampton, Wstmid, United Kingdom, SV10 0QP
- Newcross Hospital
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Alabama
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Birmingham, Alabama, United States, 35243
- University of Alabama at Birmingham
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Arizona
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Scottsdale, Arizona, United States, 85258
- AZ Cancer Ctr
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Tucson, Arizona, United States, 85724
- Arizona Cancer Center
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Arkansas
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Hot Springs, Arkansas, United States, 71913
- Genesis Cancer Ctr - Hot Springs
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Little Rock, Arkansas, United States, 72205
- University of Arkansa for Medical Sciences
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California
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Beverly Hills, California, United States, 90211
- Tower Cancer Research Foundation
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Encinitas, California, United States, 92024
- San Diego Pacific Oncology and Hematology Associates
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Loma Linda, California, United States, 92354
- Loma Linda University Cancer Center
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Los Angeles, California, United States, 90033
- University of Southern California/Norris Cancer Center
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Los Angeles, California, United States, 90095
- University of CA Los Angeles
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San Francisco, California, United States, 94117
- St. Mary's Medical Center
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Colorado
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Aurora, Colorado, United States, 80045
- University of Colorado Cancer Center
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Florida
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Jacksonville, Florida, United States, 32207
- Baptist Cancer Institute
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Lakeland, Florida, United States, 33805
- Lakeland Regional Cancer Center
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Miami, Florida, United States, 33136
- University of Miami Hospital and Clincs/SCCC
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Illinois
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Maryville, Illinois, United States, 62062
- Waren Billhartz Cancer Center
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Indiana
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Indianapolis, Indiana, United States, 46202
- Indiana University
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Iowa
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Cedar Rapids, Iowa, United States, 52402
- IA Blood and Cancer Care, PLC
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Massachusetts
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Boston, Massachusetts, United States, 02215
- Beth Israel Deaconess Medical Center
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Michigan
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Detroit, Michigan, United States, 48201
- Wayne State University
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Minnesota
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Minneapolis, Minnesota, United States, 55455
- University of Minnesota
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Missouri
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Saint Louis, Missouri, United States, 63110
- Saint Louis University
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Springfield, Missouri, United States, 65807
- St. John's Medical Research
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Nevada
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Las Vegas, Nevada, United States, 89135
- Nevada Cancer Institute
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New Jersey
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Morristown, New Jersey, United States, 07962
- Atlantic Melanoma Center
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North Carolina
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Winston-Salem, North Carolina, United States, 27103
- Piedmont Hematology
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Ohio
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Columbus, Ohio, United States, 43210
- OH State University Arthur G. James Cancer Hospital
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Oklahoma
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Oklahoma City, Oklahoma, United States, 73142
- Integris Cancer Institute of OK
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Pennsylvania
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Bethlehem, Pennsylvania, United States, 18015
- St. Luke's Hospital & Health Network
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Philadelphia, Pennsylvania, United States, 19131
- Thomas Jefferson University
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Texas
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Dallas, Texas, United States, 75246
- Mary Crowley Research Center
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Houston, Texas, United States, 77030
- Univ of TX MD Anderson Cancer Ctr
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Houston, Texas, United States, 77030
- Univ of TX Med School at Houston
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Lubbock, Texas, United States, 79410
- Covenant Health System DBA Joe Arrington Cancer Research and Treatment Center
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Richardson, Texas, United States, 75080
- HOPE Oncology
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Utah
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Salt Lake City, Utah, United States, 84106
- Utah Cancer Specialist
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Washington
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Seattle, Washington, United States, 98109
- Univ. of Washington Medical Center/Seattle Cancer Care Alliance
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Spokane, Washington, United States, 99218
- Evergreen Hematology & Oncology
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Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
Inclusion Criteria:
- Histologically or cytologically confirmed cutaneous malignant melanoma with evidence of metastasis (Stage IV).
- No prior cytotoxic chemotherapy for metastatic malignant melanoma is permitted. Prior treatment with kinase inhibitors or cytokines is permitted.
- No prior adjuvant cytotoxic chemotherapy is permitted. Prior adjuvant therapy with interferon, Granulocyte-macrophage colony-stimulating factor (GM-CSF) and/or vaccines is permitted.
- Male or non-pregnant and non-lactating female, and ≥ 18 years of age. If a female patient is of child-bearing potential, as evidenced by regular menstrual periods, she must have a negative serum pregnancy test Beta human chorionic gonadotropin (ß-hCG) within 72 hours prior to first study drug administration. If sexually active, the patient must agree to utilize contraception considered adequate and appropriate by the investigator.
- No other current active malignancy within the past 3 years.
- Radiographically-documented measurable disease (defined by the presence of at least 1 radiographically documented measurable lesion
- Patient has the following blood counts at Baseline:
- Absolute neutrophil count (ANC) ≥ 1.5 x 10^9 cells/L;
- platelets ≥ 100 x 10^9 cells/L;
- Hemoglobin (Hgb) ≥ 9 g/dL.
- Patient has the following blood chemistry levels at Baseline:
- Aspartate aminotransferase(AST) glutamic-oxaloacetic transaminase (SGOT), alanine aminotransferase (ALT) serum glutamic pyruvic transaminase (SGPT) ≤ 2.5x upper limit of normal range (ULN); ≤ 5.0 xULN if hepatic metastases present;
- total bilirubin ≤ ULN;
- creatinine ≤ 1.5 mg/dL.
- Lactate Dehydrogenase (LDH) ≤ 2.0 x ULNa
- Expected survival of > 12 weeks.
- Eastern Cooperative Oncology Group (ECOG) performance status 0-1.
- Patient or his/her legally authorized representative or guardian has been informed about the nature of the study, and has agreed to participate in the study, and signed the Informed Consent form prior to participation in any study-related activities.
Exclusion Criteria:
- History of or current evidence of brain metastases, including leptomeningeal involvement.
- Patient has pre-existing peripheral neuropathy of National Cancer Institute Common Terminology Criteria for Adverse Events (NCI CTCAE) Scale of Grade ≥ 2.
- Prior radiation to a target lesion is permitted only if there has been clear progression of the lesion since radiation was completed.
- Patient has a clinically significant concurrent illness.
- Patient is, in the investigator's opinion, unlikely to be able to complete the study through the End of Study (EOS) visit.
- Patient is currently enrolled, or will enroll in a different clinical study in which investigational therapeutic procedures are performed or investigational therapies are administered while participating in this study. Marker studies or studies evaluating biological correlates are permitted.
- Patient has serious medical risk factors involving any of the major organ systems such that the investigator considers it unsafe for the patient to receive an experimental research drug.
Study Plan
How is the study designed?
Design Details
- Primary Purpose: TREATMENT
- Allocation: RANDOMIZED
- Interventional Model: PARALLEL
- Masking: NONE
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
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EXPERIMENTAL: ABI-007
Treatment Arm A (ABI-007): Patients who receive ABI-007 will be dosed intravenously over approximately 30 minutes without steroid pre-medication and without G-CSF prophylaxis (unless modified as described below).
ABI-007 150 mg/m2 will be administered on Days 1, 8, and 15 every 4 weeks.
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Patients who receive ABI-007 will be dosed intravenously over approximately 30 minutes without steroid pre-medication and without G-CSF prophylaxis (unless modified as described below).
ABI-007 150 mg/m2 will be administered on Days 1, 8, and 15 every 4 weeks.
Other Names:
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ACTIVE_COMPARATOR: Dacarbazine
Treatment Arm B (dacarbazine): Patients who receive dacarbazine will be dosed intravenously at 1000 mg/m2 on Day 1 with steroid and antiemetic pre-medication.
Treatment will be repeated every 21 days.
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Patients who receive dacarbazine will be dosed intravenously at 1000 mg/m2 on Day 1 with steroid and antiemetic pre-medication.
Treatment will be repeated every 21 days.
Other Names:
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Progression Free Survival (PFS) Based on a Blinded Radiology Assessment of Response Using Response Evaluation Criteria in Solid Tumors (RECIST) Guidelines
Time Frame: Response assessment completed every 8 weeks until disease progression for up to 106 weeks; data cut off 30 June 2012
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PFS was defined as the time from the randomization date to the start of disease progression or patient death, whichever occurred first.
Participants who did not have disease progression or had not died were censored at the last known time that the patient was progression free.
In the event of palliative radiotherapy or surgery, they were censored at the last assessment where they were documented to be progression-free prior to the date of radiotherapy or surgery.
In follow up, participants who began new anticancer therapy prior to documented progression were censored at the last assessment where they were documented as progression free.
Those with two or more missing response assessments prior to a visit with documented disease progression (or death) were censored at the last visit where they were documented to be progression free.
RECIST defines progressive disease as a ≥ 20% increase taking as reference the smallest sum of the longest diameters recorded since the treatment began.
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Response assessment completed every 8 weeks until disease progression for up to 106 weeks; data cut off 30 June 2012
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Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Participant Survival
Time Frame: Up to 38 months; Up to data cut off of 30 June 2012
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Survival was defined as the time from the date of randomization to the date of death (any cause).
Participants were censored at the last known time that they were alive.
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Up to 38 months; Up to data cut off of 30 June 2012
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Summary of Treatment-emergent Adverse Events (AEs)
Time Frame: Maximum exposure to study drug was 106 weeks; up to data cut off of 30 June 2012
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A Treatment Emergent AE (TEAE) was any AE that began or worsened after the start of the study drug through 30 days after the last dose of study drug or end of study whichever is later. A treatment related toxicity was one considered by the investigator to be possibly, probably or definitely related to study drug. AE's were graded according to National Cancer Institute Common Terminology Criteria for Adverse Events (NCI CTCAE) V 3.0 criteria and the following scale: Grade 1 = Mild, Grade 2 = Moderate, Grade 3 = Severe, Grade 4 = Life threatening, and Grade 5 = Death A SAE is any untoward medical occurrence at any dose that is fatal or life threatening, results in persistent or significant disability or incapacity; requires prolonged hospitalizations; is a congenital anomaly birth defect in the offspring of a patient, and conditions not included in the above that may jeopardize the patient or may require intervention to prevent one of the outcomes listed above. |
Maximum exposure to study drug was 106 weeks; up to data cut off of 30 June 2012
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Number of Participants Experiencing Dose Reductions, or Dose Interruptions, or Dose Delays of Study Drug
Time Frame: Maximum study drug exposure 106 weeks; data cut off 30 June 2012
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The number of participants with dose reductions, dose interruptions and dose delays that occurred during the treatment period.
Dose reductions, interruptions and delays are typically caused by clinically significant laboratory abnormalities and /or treatment emergent adverse events/toxicities.
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Maximum study drug exposure 106 weeks; data cut off 30 June 2012
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Nadir for the Absolute Neutrophil Count (ANC) Measurements
Time Frame: Day 1 up to 106 weeks; up to data cut off 30 June 2012
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Maximal degree of myelosuppression during study drug dosing was represented by the nadir in ANC measurements over all treatment cycles.
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Day 1 up to 106 weeks; up to data cut off 30 June 2012
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Nadir for White Blood Cells (WBCs) Measurements
Time Frame: Day 1 up to 106 weeks; up to data cut off 30 June 2012
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Maximal degree of myelosuppression was represented by the nadir in white blood cells (WBCs) count measurements over all treatment cycles.
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Day 1 up to 106 weeks; up to data cut off 30 June 2012
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Nadir for Platelet Count Measurements.
Time Frame: Day 1 up to 106 weeks; up to data cut off 30 June 2012
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Maximal degree of myelosuppression was represented by the nadir in platelet count measurements over all treatment cycles.
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Day 1 up to 106 weeks; up to data cut off 30 June 2012
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Nadir for the Hemoglobin Count Measurements
Time Frame: Day 1 up to 106 weeks; up to data cut off 30 June 2012
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Maximal degree of myelosuppression during study drug dosing was represented by the nadir in hemoglobin count measurements over all treatment cycles.
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Day 1 up to 106 weeks; up to data cut off 30 June 2012
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Pharmacokinetic Parameters
Time Frame: On Cycle 1, Day 1 blood samples were taken at 0.25, 3.5, and 24 hr post-infusion end of the initial dose
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On Cycle 1, Day 1 blood samples were taken at 0.25, 3.5, and 24 hr post-infusion end of the initial dose
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Other Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Progression-free Survival (PFS) Based on Investigator Assessment Using RECIST Response Guidelines
Time Frame: Response assessments completed every 8 weeks until disease progression; up to data cut off 30 June 2012; 38 months
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PFS was defined as the time from the randomization date to the start of disease progression or patient death, whichever occurred first.
Participants who did not have disease progression or had not died were censored at the last known time that the patient was progression free.
In the event of palliative radiotherapy or surgery, they were censored at the last assessment where they were documented to be progression-free prior to the date of radiotherapy or surgery.
In follow up, patients who began new anticancer therapy prior to documented progression were censored at the last assessment where they were documented as progression free.
Those with two or more missing response assessments prior to a visit with documented disease progression (or death) were censored at the last visit where they were documented to be progression free.
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Response assessments completed every 8 weeks until disease progression; up to data cut off 30 June 2012; 38 months
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Percent of Participants Who Achieve an Objective Confirmed Complete or Partial Response Based on Blinded Radiology Assessment of Response by Response Evaluation Criteria in Solid Tumors (RECIST) Version 1.0
Time Frame: every 8 weeks; up to data cut off 30 June 2012
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RECIST defines complete response (CR): The disappearance of all known disease and no new sites or disease related symptoms confirmed at least 4 weeks after initial documentation.
All sites must be assessed, including non-measurable sites, such as effusions, or markers.
Disappearance of all non-target lesions.
The normalization of tumor marker level confirmed at least 4 weeks after initial documentation.
Partial response (PR): At least a 30% decrease in the sum of the longest diameters of target lesions, taking as a reference the baseline sum of the longest diameters confirmed at least 4 weeks after initial documentation.
PR is also recorded when all measurable disease has completely disappeared, but a non-measurable component (i.e., ascites) is still present but not progressing.
As well as persistence of one or more non-target lesion(s) and/or the maintenance of tumor marker level above the normal limits.
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every 8 weeks; up to data cut off 30 June 2012
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Percent of Participants With Stable Disease (SD) for ≥ 16 Weeks, or Confirmed Complete or Partial Response (i.e., Disease Control) Based on a Blinded Radiology Assessment of Response
Time Frame: Response assessment completed every 8 weeks until disease progression; up to data cut-off 30 June 2012
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Disease control is stable disease (SD) for >=16 weeks + complete response (CR) + partial response (PR). See Outcome #4 for definitions of CR and PR. RECIST defines SD for target lesions as neither sufficient shrinkage to qualify for partial response nor sufficient increase to qualify for progressive disease, no occurrence of progression disease for non-target lesions, and no new lesions. |
Response assessment completed every 8 weeks until disease progression; up to data cut-off 30 June 2012
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Duration of Response (DOR) in Responding Participants
Time Frame: up to data cut off 30 June 2012
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Duration of response (DOR) as measured by PFS based on radiological review for participants who achieved an objective confirmed response of CR or PR.
DOR was defined as progression-free survival in responders, i.e. as the time between the start of a complete response (CR) or partial response (PR) and the start of progressive disease (PD) or participants death from any cause, whichever occurred first.
Participants that did not have progression or had not died were censored at the last known time the participant was progression free.
Participants that had initiated other anticancer therapy prior to progression were censored at the time when new anticancer therapy was initiated.
Complete response (CR) and partial response (PR) are defined in outcome #4.
Progressive disease was defined as at least a 20% increase in the sum of the longest diameters of target lesions; or the appearance of one or more new lesions; or the unequivocal progression of a non-target lesion.
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up to data cut off 30 June 2012
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Collaborators and Investigators
Sponsor
Collaborators
Investigators
- Principal Investigator: Evan Hersh, MD, University of Arizona
Publications and helpful links
Study record dates
Study Major Dates
Study Start (ACTUAL)
Primary Completion (ACTUAL)
Study Completion (ACTUAL)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (ESTIMATE)
Study Record Updates
Last Update Posted (ACTUAL)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
- Neoplasms by Histologic Type
- Neoplasms
- Neuroectodermal Tumors
- Neoplasms, Germ Cell and Embryonal
- Neoplasms, Nerve Tissue
- Neuroendocrine Tumors
- Nevi and Melanomas
- Melanoma
- Molecular Mechanisms of Pharmacological Action
- Antineoplastic Agents
- Antineoplastic Agents, Alkylating
- Alkylating Agents
- Albumin-Bound Paclitaxel
- Dacarbazine
Other Study ID Numbers
- CA033
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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