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
18 Years
N/A
Not Enrolling
Both
Melanoma
Both
Melanoma
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 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 |
