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MelanomaPhase 3NCT00522834

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

A Phase 3 study testing Elesclomol (STA-4783) and Paclitaxel in people with Melanoma, run by Synta Pharmaceuticals Corp. at 101 sites in 8 countries.

Terminated

Stopped early. The study ended before it was planned to and will not resume.

Official record
Search all trials

Trial summary

"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. Read more about this study

Who is it for?
Ages 18 years and older
Conditions the study is for
Melanoma
What is being tested?
Elesclomol (STA-4783) and Paclitaxel
Type of treatment
Injection or infusion
Could I receive a placebo?
No, everyone receives an active treatment
How many people
630 participants
Where
101 sitesin 8 countries
Study dates
Aug 2007to Jun 2009
Phase
Phase 3
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 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

Who cannot join

  • 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

Trial locations and contacts

101 sites in 8 countries.

101 sites in 8 countries

United States61 sites

  • University of New Mexico Cancer Center

    Albuquerque, New Mexico, 87131-0001

  • Piedmont Hospital

    Atlanta, Georgia, 30309

  • Emory University Winship Cancer Institute

    Atlanta, Georgia, 30322

  • Anschutz Cancer Pavillion University of Colorado

    Aurora, Colorado, 80010

  • Mary Bird Perkins Cancer Center

    Baton Rouge, Louisiana, 70809

  • Bay Pines VA Healthcare System

    Bay Pines, Florida

  • St. Luke's Cancer Center

    Bethlehem, Pennsylvania, 18015

  • Dana Farber Cancer Institute

    Boston, Massachusetts, 02115

  • Beth Israel Deaconess Medical Center

    Boston, Massachusetts, 02215

  • UNC School of Medicine - Division of Hematology/Oncology

    Chapel Hill, North Carolina, 27599

  • Carolina Hematology & Oncology Associates

    Charlotte, North Carolina, 28203

  • Virginia Oncology Associates

    Chesapeake, Virginia, 23320

  • Rush University Hospital

    Chicago, Illinois

  • The Christ Hospital

    Cincinnati, Ohio, 45219

  • Ellis Fischels Cancer Center

    Columbia, Missouri

  • The Ohio State University.

    Columbus, Ohio, 43210

  • Mark H. Zangmeister Cancer Center

    Columbus, Ohio, 43219

  • Texas Oncology, PA

    Dallas, Texas, 75246

  • Karmanos Cancer Institute, Wayne State University

    Detroit, Michigan

  • Duke University Medical Center

    Durham, North Carolina, 27710

  • Evanston Northwestern Healthcare

    Evanston, Illinois, 60201

  • Goshen Center for Cancer Care

    Goshen, Indiana, 46526

  • Leo W. Jenkins Cancer Center

    Greenville, North Carolina, 27834

  • Brody School of Medicine at East Carolina State University

    Greenville, North Carolina, 27858

  • Cancer Center of the Carolinas

    Greenville, South Carolina

  • Indiana University Melvin and Bren Simon Cancer Center

    Indianapolis, Indiana, 46202

  • Joliet Oncology/Hematology Associates, LTD

    Joliet, Illinois, 60435

  • University of California San Diego Moores UCSD Cancer Center

    La Jolla, California, 92093

  • University of California, San Diego

    La Jolla, California, 92093

  • Monter Cancer Center North Shore Hospital

    Lake Success, New York

  • Dartmouth Hitchcock Medical Center

    Lebanon, New Hampshire, 03756

  • Southeast Nebraska Hematology/Oncology

    Lincoln, Nebraska, 68510

  • Winthrop P. Rockefeller Cancer Institute

    Little Rock, Arkansas, 72205

  • The Angeles Clinic & Research Institute

    Los Angeles, California, 90025

  • Jonsson Comprehensive Cancer Center Univ. of California Los Angeles

    Los Angeles, California, 90095

  • Marshfield Clinic

    Marshfield, Wisconsin, 54449

  • Univ. of Miami Hospital and Clinics

    Miami, Florida, 33136

  • Atlantic Health Research - Mountainside Hospital

    Montclair, New Jersey, 07042

  • Vanderbilt Medical Center

    Nashville, Tennessee, 27232-6868

  • Weill Medical College of Cornell University - Division of Hematology and Medical Oncology

    New York, New York, 10021

  • NYU Clinical Cancer Center

    New York, New York

  • Virginia Oncology Associates

    Newport News, Virginia, 23606

  • Oncology Specialists, S.C.

    Niles, Illinois, 60714

  • Virginia Oncology Associates

    Norfolk, Virginia, 23502

  • Nebraska Methodist Cancer Center

    Omaha, Nebraska

  • MD Anderson Cancer Center

    Orlando, Florida, 32806

  • Oncology Specialists, SC

    Park Ridge, Illinois, 60068

  • Abramson Cancer Center at University of Pennsylvania

    Philadelphia, Pennsylvania, 19104

  • Fox Chase Cancer Center

    Philadelphia, Pennsylvania, 19111

  • Cancer Pavilion

    Pittsburgh, Pennsylvania, 15323

  • Providence Cancer Center Clinical Trials

    Portland, Oregon, 97213

  • Virginia Cancer Institute

    Richmond, Virginia, 23230

  • Hubert H. Humphrey Cancer Center

    Robbinsdale, Minnesota, 55422

  • San Antonio Cancer Institute

    San Antonio, Texas, 78229

  • Pacific Medical Center Research Institute

    San Francisco, California, 94115

  • Redwood Regional Medical Group

    Santa Rosa, California, 94503

  • Seattle Cancer Care Alliance

    Seattle, Washington, 98109-1023

  • Hematology Oncology, P.C.

    Stamford, Connecticut, 06902

  • Stony Brook University Medical Center- Cancer Center

    Stony Brook, New York, 11794-9446

  • Arizona Cancer Center

    Tucson, Arizona, 85724

  • Derrick L. Davis Regional Cancer Center

    Winston-Salem, North Carolina, 27103

Other trials in United States

Australia11 sites

  • Royal Adelaide Cancer Centre Medical Oncology

    Adelaide, SA 5000

  • Fremantle Hospital

    Fremantle, Western Australia, 6160

  • Royal Hobart Hospital

    Hobart, Tasmania

  • Lismore Base Hospital, Cancer Care & Haematology Unit

    Lismore, New South Wales

  • Patricia Ritchie Centre for Cancer Care and Research, Mater Hospital

    North Sydney

  • Redcliffe Hospital

    Redcliffe, Queensland, 4020

  • The Tweed Hospital

    Tweed Heads

  • Newcastle Melanoma Unit - Calvary Mater Newcastle

    Waratah, New South Wales, 2298

  • Department of Medical Oncology, Westmead Hospital

    Westmead

  • Southern Medical Day Care Centre

    Wollongong, New South Wales, 2500

  • Princess Alexandra Hospital

    Wooloongabba, Queensland, 4102

Other trials in Australia

Germany10 sites

  • Vivantes Klinikum Im Friedrichshain

    Berlin

  • Vivantes Klinikum Neukölln

    Berlin

  • Elbe-Klinikum Buxtehude

    Buxtehude

  • Universität zu Köln

    Cologne

  • University Frankfurt

    Frankfurt am Main

  • University of Kiel

    Kiel

  • Universitätsklinikum Leipzig

    Leipzig

  • Universitätsklinikum Mannheim

    Mannheim

  • Universitätsklinikum Münster

    Münster

  • Universitätsklinikum Würzburg

    Würzburg

Other trials in Germany

Romania6 sites

  • County Hospital Brasov - Oncology Department

    Brasov, 500 117

  • Oncology Institute "Prof. Dr. Ion Chiricuta"

    Cluj-Napoca, 400 015

  • Clinical County Hospital " Alexandru Simionescu" Hunedoara

    Hunedoara, 331 057

  • Center of Medical Oncology

    Iași, 700 106

  • Clinical County Hospital Sibiu

    Sibiu, 550 245

  • Oncology- Chemotherapy Clinic - Emergency Municipal Clinical Hospital

    Timișoara, 300 223

Other trials in Romania

Canada5 sites

  • Tom Baker Cancer Centre

    Calgary, Alberta

  • Cross Cancer Institute

    Edmonton, AB T6G 1Z2

  • Northeastern Ontario Regional Cancer Centre

    Greater Sudbury, Ontario

  • QE II Health Sciences Center

    Halifax, Nova Scotia

  • Princess Margaret Hospital

    Toronto

Other trials in Canada

Spain4 sites

  • Hospital Universitario de la Princessa Servicio de Oncología Médica

    Madrid, 28006

  • Hospital Universitario Central de Asturias

    Oviedo, Principality of Asturias, 33006

  • Clinica Universitaria de Navarra

    Pamplona, 31008

  • Hospital Virgen de la Salud - Servicio de Oncología Médica Ciclos

    Toledo

Other trials in Spain

United Kingdom3 sites

  • Oncology Centre Addenbrookes's Hospital

    Cambridge, CB2 0QQ

  • Northern Centre for Cancer Treatment Newcastle General Hospital

    Newcastle upon Tyne, NE4 6BE

  • Dorset Cancer Centre Poole Hospital NHS Foundation Trust

    Poole, BH15 2JB

Other trials in United Kingdom

Puerto Rico1 site

  • VA Medical Center

    San Juan, 00927

Other trials in Puerto Rico

About this study

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)

"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. "

Conditions
Melanoma
Being tested
Elesclomol (STA-4783), Paclitaxel
Keywords
melanoma, oncology, Stage IV Metastatic Melanoma
Medical subject headings
Melanoma, Neoplasms

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Elesclomol (STA-4783)Drug

    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

  • PaclitaxelDrug

    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

Study groups in NCT00522834
Study groupRoleWhat they receive
1Active comparatorElesclomol (STA-4783) in Combination With Paclitaxel
Receives: Drug: Elesclomol (STA-4783)
2OtherPaclitaxel alone
Receives: Drug: Paclitaxel

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Progression free survival

    Measured: June 2009

Secondary outcomes (6)

  1. Overall Survival

    Measured: December 2009

  2. Objective response rate

    Measured: December 2009

  3. Clinical benefit rate

    Measured: December 2009

  4. Duration of objective response

    Measured: December 2009

  5. Safety

    Measured: December 2009

  6. Pharmacokinetics

    Measured: December 2009

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted30 Aug 2007 (estimated)
  2. Study startAug 2007
  3. Primary completionJun 2009
  4. Study completionJun 2009

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 3
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Masking
Quadruple blind
Who is masked
Participant, Care provider, Investigator, Outcomes assessor
Enrolment
630 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT00522834
Sponsor's protocol ID
4783-08
Status last verified
Jan 2014
First submitted
28 Aug 2007
Last updated
4 Mar 2014
Results posted
No
Data monitoring committee
Yes

Publications

  • O'Day SJ, Eggermont AM, Chiarion-Sileni V, Kefford R, Grob JJ, Mortier L, Robert C, Schachter J, Testori A, Mackiewicz J, Friedlander P, Garbe C, Ugurel S, Collichio F, Guo W, Lufkin J, Bahcall S, Vukovic V, Hauschild A. Final results of phase III SYMMETRY study: randomized, double-blind trial of elesclomol plus paclitaxel versus paclitaxel alone as treatment for chemotherapy-naive patients with advanced melanoma. J Clin Oncol. 2013 Mar 20;31(9):1211-8. doi: 10.1200/JCO.2012.44.5585. Epub 2013 Feb 11.

    PubMed 23401447

Questions about this trial

What is this clinical trial studying?

A Phase 3 study testing Elesclomol (STA-4783) and Paclitaxel in people with Melanoma, run by Synta Pharmaceuticals Corp. at 101 sites in 8 countries.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 7 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: stopped early, as of the sponsor's last update on 4 Mar 2014. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 101 sites in United States, Australia, Germany, Romania, Canada and 3 more countries. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

The study was stopped early. Results are not available in the source record.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Progression free survival (time frame: June 2009). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT00522834, which also lists 1 linked publication.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 4 Mar 2014.

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