Know Cancer

forgot password

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
Not Enrolling

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:


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:



United States: Food and Drug Administration

Study ID:




Start Date:

August 2007

Completion Date:

June 2009

Related Keywords:

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



Arizona Cancer Center Tucson, Arizona  85724
Fox Chase Cancer Center Philadelphia, Pennsylvania  19111
Beth Israel Deaconess Medical Center Boston, Massachusetts  02215
Marshfield Clinic Marshfield, Wisconsin  54449
Mary Bird Perkins Cancer Center Baton Rouge, Louisiana  70809
Virginia Oncology Associates Newport News, Virginia  23606
Hubert H. Humphrey Cancer Center Coon Rapids, Minnesota  55433
Indiana University Melvin and Bren Simon Cancer Center Indianapolis, Indiana  46202-5289
University of New Mexico Cancer Center Albuquerque, New Mexico  87131-5636
Piedmont Hospital Atlanta, Georgia  30309
Seattle Cancer Care Alliance Seattle, Washington  98109
San Antonio Cancer Institute San Antonio, Texas  78229-3264
Evanston Northwestern Healthcare Evanston, Illinois  60201
Hematology Oncology, P.C. Stamford, Connecticut  06902
Duke University Medical Center Durham, North Carolina  27710
Oncology Specialists, SC Park Ridge, Illinois  60068
Dana Farber Cancer Institute Boston, Massachusetts  02115
Dartmouth Hitchcock Medical Center Lebanon, New Hampshire  03756
The Angeles Clinic & Research Institute Los Angeles, California  90404
University of California, San Diego La Jolla, California  92037-1709
Oncology Specialists, S.C. Park Ridge, Illinois  60068
Virginia Cancer Institute Richmond, Virginia  23230
Redwood Regional Medical Group Santa Rosa, California  95403
Texas Oncology, PA Dallas, Texas  75246-2006
Leo W. Jenkins Cancer Center Greenville, North Carolina  
Cancer Center of the Carolinas Greenville, South Carolina  29615
Karmanos Cancer Institute, Wayne State University Detroit, Michigan  48201
Emory University Winship Cancer Institute Atlanta, Georgia  30322
Vanderbilt Medical Center Nashville, Tennessee  37232-2765
NYU Clinical Cancer Center New York, New York  10016
Southeast Nebraska Hematology/Oncology Lincoln, Nebraska  68510
MD Anderson Cancer Center Orlando, Florida  32806
Nebraska Methodist Cancer Center Omaha, Nebraska  68114
The Christ Hospital Cincinnati, Ohio  45219
Abramson Cancer Center at University of Pennsylvania Philadelphia, Pennsylvania  19104
St. Luke's Cancer Center Bethlehem, Pennsylvania  18015
Winthrop P. Rockefeller Cancer Institute Little Rock, Arkansas  72205
University of California San Diego Moores UCSD Cancer Center La Jolla, California  92093
Jonsson Comprehensive Cancer Center Univ. of California Los Angeles Los Angeles, California  90095
Pacific Medical Center Research Institute San Francisco, California  94115
Anschutz Cancer Pavillion University of Colorado Aurora, Colorado  80010
Bay Pines VA Healthcare System Bay Pines, Florida  
Univ. of Miami Hospital and Clinics Miami, Florida  33136
Rush University Hospital Chicago, Illinois  
Joliet Oncology/Hematology Associates, LTD Joliet, Illinois  60435
Goshen Center for Cancer Care Goshen, Indiana  46526
Ellis Fischels Cancer Center Columbia, Missouri  
Atlantic Health Research - Mountainside Hospital Montclair, New Jersey  07042
Monter Cancer Center North Shore Hospital Lake Success, New York  
Weill Medical College of Cornell University - Division of Hematology and Medical Oncology New York, New York  10021
Stony Brook University Medical Center- Cancer Center Stony Brook, New York  11794-9446
UNC School of Medicine - Division of Hematology/Oncology Chapel Hill, North Carolina  27599
Carolina Hematology & Oncology Associates Charlotte, North Carolina  28203
Brody School of Medicine at East Carolina State University Greenville, North Carolina  27858
Derrick L. Davis Regional Cancer Center Winston-Salem, North Carolina  27103
Mark H. Zangmeister Cancer Center Columbus, Ohio  43219
The Ohio State University. Columbus, Ohio  43210
Providence Cancer Center Clinical Trials Portland, Oregon  97213
Cancer Pavilion Pittsburgh, Pennsylvania  15323