Elesclomol (STA-4783) With Paclitaxel Versus Paclitaxel Alone in Melanoma

This study has been terminated.
Sponsor:
Information provided by (Responsible Party):
Synta Pharmaceuticals Corp.
ClinicalTrials.gov Identifier:
NCT00522834
First received: August 28, 2007
Last updated: January 31, 2014
Last verified: January 2014
  Purpose

"Elesclomol (STA-4783), N-malonyl-bis (N'-methyl-N'-thiobenzoylhydrazide) is a new chemical entity with a novel structure. STA-4783 induces an oxidative stress response in cells. This response is characterized by increased production of gene families that protect against different cellular stresses, including excessive heat, the presence of reactive oxygen species such as oxygen radicals, or the presence of heavy metals.

Subjects will participate in up to 2 weeks of screening during which time they will complete all screening procedures. Eligible subjects who have not received any prior cytotoxic chemotherapeutic agent for melanoma will be randomized in a 1:1 ratio to receive either STA-4783 213 mg/m2 in combination with paclitaxel 80 mg/m2 or paclitaxel 80 mg/m2 alone.

One treatment cycle will consist of weekly treatments for 3 weeks, followed by a 1-week rest period. Cycles will be repeated every 4 weeks until disease progression. Tumor assessments will be performed every 8 weeks from the date of randomization or sooner if the Investigator suspects progression has occurred based on clinical signs and symptoms. "


Condition Intervention Phase
Melanoma
Drug: Elesclomol (STA-4783)
Drug: Paclitaxel
Phase 3

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

Resource links provided by NLM:


Further study details as provided by Synta Pharmaceuticals Corp.:

Primary Outcome Measures:
  • Progression free survival [ Time Frame: June 2009 ] [ Designated as safety issue: Yes ]

Secondary Outcome Measures:
  • Overall Survival [ Time Frame: December 2009 ] [ Designated as safety issue: Yes ]
  • Objective response rate [ Time Frame: December 2009 ] [ Designated as safety issue: Yes ]
  • Clinical benefit rate [ Time Frame: December 2009 ] [ Designated as safety issue: No ]
  • Duration of objective response [ Time Frame: December 2009 ] [ Designated as safety issue: No ]
  • Safety [ Time Frame: December 2009 ] [ Designated as safety issue: Yes ]
  • Pharmacokinetics [ Time Frame: December 2009 ] [ Designated as safety issue: No ]

Enrollment: 630
Study Start Date: August 2007
Study Completion Date: June 2009
Primary Completion Date: June 2009 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Active Comparator: 1
Elesclomol (STA-4783) in Combination With Paclitaxel
Drug: Elesclomol (STA-4783)
213 mg/m2 Elesclomol (STA-4783) plus 80 mg/m2 paclitaxel administered intravenously once a week for the first 3 weeks of a 4 week cycle. Number of cycles: Until progression or unacceptable toxicity develops
Other Name: Elesclomol (STA-4783)
2
Paclitaxel alone
Drug: Paclitaxel
80 mg/m2 paclitaxel alone administered intravenously once a week for the first 3 weeks of a 4 weeks cycle. Number of cycles: Until progression or unacceptable toxicity develops

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00522834

  Hide Study Locations
Locations
United States, Arizona
Arizona Cancer Center
Tucson, Arizona, United States, 85724
United States, Arkansas
Winthrop P. Rockefeller Cancer Institute
Little Rock, Arkansas, United States, 72205
United States, California
University of California, San Diego
La Jolla, California, United States, 92093
University of California San Diego Moores UCSD Cancer Center
La Jolla, California, United States, 92093
Jonsson Comprehensive Cancer Center Univ. of California Los Angeles
Los Angeles, California, United States, 90095
The Angeles Clinic & Research Institute
Los Angeles, California, United States, 90025
Pacific Medical Center Research Institute
San Francisco, California, United States, 94115
Redwood Regional Medical Group
Santa Rosa, California, United States, 94503
United States, Colorado
Anschutz Cancer Pavillion University of Colorado
Aurora, Colorado, United States, 80010
United States, Connecticut
Hematology Oncology, P.C.
Stamford, Connecticut, United States, 06902
United States, Florida
Bay Pines VA Healthcare System
Bay Pines, Florida, United States
Univ. of Miami Hospital and Clinics
Miami, Florida, United States, 33136
MD Anderson Cancer Center
Orlando, Florida, United States, 32806
United States, Georgia
Piedmont Hospital
Atlanta, Georgia, United States, 30309
Emory University Winship Cancer Institute
Atlanta, Georgia, United States, 30322
United States, Illinois
Rush University Hospital
Chicago, Illinois, United States
Evanston Northwestern Healthcare
Evanston, Illinois, United States, 60201
Joliet Oncology/Hematology Associates, LTD
Joliet, Illinois, United States, 60435
Oncology Specialists, S.C.
Niles, Illinois, United States, 60714
Oncology Specialists, SC
Park Ridge, Illinois, United States, 60068
United States, Indiana
Goshen Center for Cancer Care
Goshen, Indiana, United States, 46526
Indiana University Melvin and Bren Simon Cancer Center
Indianapolis, Indiana, United States, 46202
United States, Louisiana
Mary Bird Perkins Cancer Center
Baton Rouge, Louisiana, United States, 70809
United States, Massachusetts
Dana Farber Cancer Institute
Boston, Massachusetts, United States, 02115
Beth Israel Deaconess Medical Center
Boston, Massachusetts, United States, 02215
United States, Michigan
Karmanos Cancer Institute, Wayne State University
Detroit, Michigan, United States
United States, Minnesota
Hubert H. Humphrey Cancer Center
Robbinsdale, Minnesota, United States, 55422
United States, Missouri
Ellis Fischels Cancer Center
Columbia, Missouri, United States
United States, Nebraska
Southeast Nebraska Hematology/Oncology
Lincoln, Nebraska, United States, 68510
Nebraska Methodist Cancer Center
Omaha, Nebraska, United States
United States, New Hampshire
Dartmouth Hitchcock Medical Center
Lebanon, New Hampshire, United States, 03756
United States, New Jersey
Atlantic Health Research - Mountainside Hospital
Montclair, New Jersey, United States, 07042
United States, New Mexico
University of New Mexico Cancer Center
Albuquerque, New Mexico, United States, 87131-0001
United States, New York
Monter Cancer Center North Shore Hospital
Lake Success, New York, United States
NYU Clinical Cancer Center
New York, New York, United States
Weill Medical College of Cornell University - Division of Hematology and Medical Oncology
New York, New York, United States, 10021
Stony Brook University Medical Center- Cancer Center
Stony Brook, New York, United States, 11794-9446
United States, North Carolina
UNC School of Medicine - Division of Hematology/Oncology
Chapel Hill, North Carolina, United States, 27599
Carolina Hematology & Oncology Associates
Charlotte, North Carolina, United States, 28203
Duke University Medical Center
Durham, North Carolina, United States, 27710
Leo W. Jenkins Cancer Center
Greenville, North Carolina, United States, 27834
Brody School of Medicine at East Carolina State University
Greenville, North Carolina, United States, 27858
Derrick L. Davis Regional Cancer Center
Winston-Salem, North Carolina, United States, 27103
United States, Ohio
The Christ Hospital
Cincinnati, Ohio, United States, 45219
Mark H. Zangmeister Cancer Center
Columbus, Ohio, United States, 43219
The Ohio State University.
Columbus, Ohio, United States, 43210
United States, Oregon
Providence Cancer Center Clinical Trials
Portland, Oregon, United States, 97213
United States, Pennsylvania
St. Luke's Cancer Center
Bethlehem, Pennsylvania, United States, 18015
Fox Chase Cancer Center
Philadelphia, Pennsylvania, United States, 19111
Abramson Cancer Center at University of Pennsylvania
Philadelphia, Pennsylvania, United States, 19104
Cancer Pavilion
Pittsburgh, Pennsylvania, United States, 15323
United States, South Carolina
Cancer Center of the Carolinas
Greenville, South Carolina, United States
United States, Tennessee
Vanderbilt Medical Center
Nashville, Tennessee, United States, 27232-6868
United States, Texas
Texas Oncology, PA
Dallas, Texas, United States, 75246
San Antonio Cancer Institute
San Antonio, Texas, United States, 78229
United States, Virginia
Virginia Oncology Associates
Chesapeake, Virginia, United States, 23320
Virginia Oncology Associates
Newport News, Virginia, United States, 23606
Virginia Oncology Associates
Norfolk, Virginia, United States, 23502
Virginia Cancer Institute
Richmond, Virginia, United States, 23230
United States, Washington
Seattle Cancer Care Alliance
Seattle, Washington, United States, 98109-1023
United States, Wisconsin
Marshfield Clinic
Marshfield, Wisconsin, United States, 54449
Australia, New South Wales
Lismore Base Hospital, Cancer Care & Haematology Unit
Lismore, New South Wales, Australia
Newcastle Melanoma Unit - Calvary Mater Newcastle
Waratah, New South Wales, Australia, 2298
Southern Medical Day Care Centre
Wollongong, New South Wales, Australia, 2500
Australia, Queensland
Redcliffe Hospital
Redcliffe, Queensland, Australia, 4020
Princess Alexandra Hospital
Wooloongabba, Queensland, Australia, 4102
Australia, Tasmania
Royal Hobart Hospital
Hobart, Tasmania, Australia
Australia, Western Australia
Fremantle Hospital
Fremantle, Western Australia, Australia, 6160
Australia
Royal Adelaide Cancer Centre Medical Oncology
Adelaide, Australia, SA 5000
Patricia Ritchie Centre for Cancer Care and Research, Mater Hospital
North Sydney, Australia
The Tweed Hospital
Tweed Heads, Australia
Department of Medical Oncology, Westmead Hospital
Westmead, Australia
Canada, Alberta
Tom Baker Cancer Centre
Calgary, Alberta, Canada
Canada, Nova Scotia
QE II Health Sciences Center
Halifax, Nova Scotia, Canada
Canada, Ontario
Northeastern Ontario Regional Cancer Centre
Sudbury, Ontario, Canada
Canada
Cross Cancer Institute
Edmonton, Canada, AB T6G 1Z2
Princess Margaret Hospital
Toranto, Canada
Germany
Vivantes Klinikum Im Friedrichshain
Berlin, Germany
Vivantes Klinikum Neukölln
Berlin, Germany
Elbe-Klinikum Buxtehude
Buxtehude, Germany
University Frankfurt
Frankfurt/Main, Germany
University of Kiel
Kiel, Germany
Universität zu Köln
Köln, Germany
Universitätsklinikum Leipzig
Leipzig, Germany
Universitätsklinikum Mannheim
Mannheim, Germany
Universitätsklinikum Münster
Münster, Germany
Universitätsklinikum Würzburg
Würzburg, Germany
Puerto Rico
VA Medical Center
San Juan, Puerto Rico, 00927
Romania
County Hospital Brasov - Oncology Department
Brasov, Romania, 500 117
Oncology Institute "Prof. Dr. Ion Chiricuta"
Cluj Napoca, Romania, 400 015
Clinical County Hospital " Alexandru Simionescu" Hunedoara
Hunedoara, Romania, 331 057
Center of Medical Oncology
Iasi, Romania, 700 106
Clinical County Hospital Sibiu
Sibiu, Romania, 550 245
Oncology- Chemotherapy Clinic - Emergency Municipal Clinical Hospital
Timisoara, Romania, 300 223
Spain
Hospital Universitario Central de Asturias
Oviedo, Asturias, Spain, 33006
Hospital Universitario de la Princessa Servicio de Oncología Médica
Madrid, Spain, 28006
Clinica Universitaria de Navarra
Pamplona, Spain, 31008
Hospital Virgen de la Salud - Servicio de Oncología Médica Ciclos
Toledo, Spain
United Kingdom
Oncology Centre Addenbrookes's Hospital
Cambridge, United Kingdom, CB2 0QQ
Northern Centre for Cancer Treatment Newcastle General Hospital
Newcastle upon Tyne, United Kingdom, NE4 6BE
Dorset Cancer Centre Poole Hospital NHS Foundation Trust
Poole, United Kingdom, BH15 2JB
Sponsors and Collaborators
Synta Pharmaceuticals Corp.
  More Information

No publications provided by Synta Pharmaceuticals Corp.

Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: Synta Pharmaceuticals Corp.
ClinicalTrials.gov Identifier: NCT00522834     History of Changes
Other Study ID Numbers: 4783-08
Study First Received: August 28, 2007
Last Updated: January 31, 2014
Health Authority: United States: Food and Drug Administration
Argentina: Administracion Nacional de Medicamentos, Alimentos y Tecnologia Medica
Australia: Department of Health and Ageing Therapeutic Goods Administration
Belgium: Federal Agency for Medicinal Products and Health Products
Brazil: National Committee of Ethics in Research
Canada: Health Canada
Chile: Instituto de Salud Pública de Chile
Czech Republic: State Institute for Drug Control
France: Afssaps - Agence française de sécurité sanitaire des produits de santé (Saint-Denis)
Germany: Federal Institute for Drugs and Medical Devices
Israel: Ministry of Health
Italy: The Italian Medicines Agency
Poland: Office for Registration of Medicinal Products, Medical Devices and Biocidal Products
Romania: National Medicines Agency
United Kingdom: Medicines and Healthcare Products Regulatory Agency

Keywords provided by Synta Pharmaceuticals Corp.:
melanoma
oncology
Stage IV Metastatic Melanoma

Additional relevant MeSH terms:
Melanoma
Neuroendocrine Tumors
Neuroectodermal Tumors
Neoplasms, Germ Cell and Embryonal
Neoplasms by Histologic Type
Neoplasms
Neoplasms, Nerve Tissue
Nevi and Melanomas
Paclitaxel
Antineoplastic Agents, Phytogenic
Antineoplastic Agents
Therapeutic Uses
Pharmacologic Actions
Tubulin Modulators
Antimitotic Agents
Mitosis Modulators
Molecular Mechanisms of Pharmacological Action

ClinicalTrials.gov processed this record on September 18, 2014