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A Randomized, Double-Blind, Phase 3 Trial of Elesclomol (STA-4783) in Combination With Paclitaxel Versus Paclitaxel Alone for Treatment of Chemotherapy-Naïve Subjects With Stage IV Metastatic Melanoma (SYMMETRY)


Phase 3
18 Years
N/A
Not Enrolling
Both
Melanoma

Thank you

Trial Information

A Randomized, Double-Blind, Phase 3 Trial of Elesclomol (STA-4783) in Combination With Paclitaxel Versus Paclitaxel Alone for Treatment of Chemotherapy-Naïve Subjects With Stage IV Metastatic Melanoma (SYMMETRY)


Inclusion Criteria:



- Histologically confirmed metastatic (Stage IV) melanoma of cutaneous origin

- ECOG performance status of <=2

- Measurable disease according to modified RECIST

- Life expectancy of greater than 12 weeks

- LDH <= 2.0 x ULN

- Clinical lab values within protocol parameters.

- At least 18 years old and able and willing to provide informed consent to participate

Exclusion Criteria:

- Previous cytotoxic chemotherapy treatment for melanoma

- Received more than one regimen of immunotherapy, kinase inhibitor, biologic therapy,
vaccine or investigational non-chemotherapeutic treatment for melanoma.

- Presence of brain metastases

- Presence or history (<= 5 years) of a second malignancy other than nonmelanoma skin
cancer or cervical carcinoma in situ

- Female subjects who are pregnant or nursing

Type of Study:

Interventional

Study Design:

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Treatment

Outcome Measure:

Progression free survival

Outcome Time Frame:

June 2009

Safety Issue:

Yes

Authority:

United States: Food and Drug Administration

Study ID:

4783-08

NCT ID:

NCT00522834

Start Date:

August 2007

Completion Date:

June 2009

Related Keywords:

  • Melanoma
  • melanoma
  • oncology
  • Stage IV Metastatic Melanoma
  • Melanoma

Name

Location

Arizona Cancer CenterTucson, Arizona  85724
Fox Chase Cancer CenterPhiladelphia, Pennsylvania  19111
Beth Israel Deaconess Medical CenterBoston, Massachusetts  02215
Marshfield ClinicMarshfield, Wisconsin  54449
Mary Bird Perkins Cancer CenterBaton Rouge, Louisiana  70809
Virginia Oncology AssociatesNewport News, Virginia  23606
Hubert H. Humphrey Cancer CenterCoon Rapids, Minnesota  55433
Indiana University Melvin and Bren Simon Cancer CenterIndianapolis, Indiana  46202-5289
University of New Mexico Cancer CenterAlbuquerque, New Mexico  87131-5636
Piedmont HospitalAtlanta, Georgia  30309
Seattle Cancer Care AllianceSeattle, Washington  98109
San Antonio Cancer InstituteSan Antonio, Texas  78229-3264
Evanston Northwestern HealthcareEvanston, Illinois  60201
Hematology Oncology, P.C.Stamford, Connecticut  06902
Duke University Medical CenterDurham, North Carolina  27710
Oncology Specialists, SCPark Ridge, Illinois  60068
Dana Farber Cancer InstituteBoston, Massachusetts  02115
Dartmouth Hitchcock Medical CenterLebanon, New Hampshire  03756
The Angeles Clinic & Research InstituteLos Angeles, California  90404
University of California, San DiegoLa Jolla, California  92037-1709
Oncology Specialists, S.C.Park Ridge, Illinois  60068
Virginia Cancer InstituteRichmond, Virginia  23230
Redwood Regional Medical GroupSanta Rosa, California  95403
Texas Oncology, PADallas, Texas  75246-2006
Leo W. Jenkins Cancer CenterGreenville, North Carolina  
Cancer Center of the CarolinasGreenville, South Carolina  29615
Karmanos Cancer Institute, Wayne State UniversityDetroit, Michigan  48201
Emory University Winship Cancer InstituteAtlanta, Georgia  30322
Vanderbilt Medical CenterNashville, Tennessee  37232-2765
NYU Clinical Cancer CenterNew York, New York  10016
Southeast Nebraska Hematology/OncologyLincoln, Nebraska  68510
MD Anderson Cancer CenterOrlando, Florida  32806
Nebraska Methodist Cancer CenterOmaha, Nebraska  68114
The Christ HospitalCincinnati, Ohio  45219
Abramson Cancer Center at University of PennsylvaniaPhiladelphia, Pennsylvania  19104
St. Luke's Cancer CenterBethlehem, Pennsylvania  18015
Winthrop P. Rockefeller Cancer InstituteLittle Rock, Arkansas  72205
University of California San Diego Moores UCSD Cancer CenterLa Jolla, California  92093
Jonsson Comprehensive Cancer Center Univ. of California Los AngelesLos Angeles, California  90095
Pacific Medical Center Research InstituteSan Francisco, California  94115
Anschutz Cancer Pavillion University of ColoradoAurora, Colorado  80010
Bay Pines VA Healthcare SystemBay Pines, Florida  
Univ. of Miami Hospital and ClinicsMiami, Florida  33136
Rush University HospitalChicago, Illinois  
Joliet Oncology/Hematology Associates, LTDJoliet, Illinois  60435
Goshen Center for Cancer CareGoshen, Indiana  46526
Ellis Fischels Cancer CenterColumbia, Missouri  
Atlantic Health Research - Mountainside HospitalMontclair, New Jersey  07042
Monter Cancer Center North Shore HospitalLake Success, New York  
Weill Medical College of Cornell University - Division of Hematology and Medical OncologyNew York, New York  10021
Stony Brook University Medical Center- Cancer CenterStony Brook, New York  11794-9446
UNC School of Medicine - Division of Hematology/OncologyChapel Hill, North Carolina  27599
Carolina Hematology & Oncology AssociatesCharlotte, North Carolina  28203
Brody School of Medicine at East Carolina State UniversityGreenville, North Carolina  27858
Derrick L. Davis Regional Cancer CenterWinston-Salem, North Carolina  27103
Mark H. Zangmeister Cancer CenterColumbus, Ohio  43219
The Ohio State University.Columbus, Ohio  43210
Providence Cancer Center Clinical TrialsPortland, Oregon  97213
Cancer PavilionPittsburgh, Pennsylvania  15323