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

January 31, 2014 updated by: Synta Pharmaceuticals Corp.

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)

"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. "

Study Overview

Status

Terminated

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

630

Phase

  • Phase 3

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

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

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (ADULT, OLDER_ADULT)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: TREATMENT
  • Allocation: RANDOMIZED
  • Interventional Model: PARALLEL
  • Masking: QUADRUPLE

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
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: 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

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Progression free survival
Time Frame: June 2009
June 2009

Secondary Outcome Measures

Outcome Measure
Time Frame
Overall Survival
Time Frame: December 2009
December 2009
Objective response rate
Time Frame: December 2009
December 2009
Clinical benefit rate
Time Frame: December 2009
December 2009
Duration of objective response
Time Frame: December 2009
December 2009
Safety
Time Frame: December 2009
December 2009
Pharmacokinetics
Time Frame: December 2009
December 2009

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Synta Pharmaceuticals Corp.

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

August 1, 2007

Primary Completion (ACTUAL)

June 1, 2009

Study Completion (ACTUAL)

June 1, 2009

Study Registration Dates

First Submitted

August 28, 2007

First Submitted That Met QC Criteria

August 29, 2007

First Posted (ESTIMATE)

August 30, 2007

Study Record Updates

Last Update Posted (ESTIMATE)

March 4, 2014

Last Update Submitted That Met QC Criteria

January 31, 2014

Last Verified

January 1, 2014

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 4783-08

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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