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

Melanoma Clinical Trial

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)

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT00522834
• Other study ID #: 4783-08
• Status: Terminated
• Phase: Phase 3
• First received: August 28, 2007
• Last updated: January 31, 2014
• Start date: August 2007
• Est. completion date: June 2009

Study information

• Verified date: January 2014
• Source: Synta Pharmaceuticals Corp.
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Food and Drug AdministrationArgentina: Administracion Nacional de Medicamentos, Alimentos y Tecnologia MedicaAustralia: Department of Health and Ageing Therapeutic Goods AdministrationBelgium: Federal Agency for Medicinal Products and Health ProductsBrazil: National Committee of Ethics in ResearchCanada: Health CanadaChile: Instituto de Salud Pública de ChileCzech Republic: State Institute for Drug ControlFrance: Afssaps - Agence française de sécurité sanitaire des produits de santé (Saint-Denis)Germany: Federal Institute for Drugs and Medical DevicesIsrael: Ministry of HealthItaly: The Italian Medicines AgencyPoland: Office for Registration of Medicinal Products, Medical Devices and Biocidal ProductsRomania: National Medicines AgencyUnited Kingdom: Medicines and Healthcare Products Regulatory Agency
• Study type: Interventional

Clinical 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. 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. "

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 630
• Est. completion date: June 2009
• Est. primary completion date: June 2009
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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 Design

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

Related Conditions & MeSH terms

• Melanoma

Intervention

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
• 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

Locations

Country	Name	City	State
Australia	Royal Adelaide Cancer Centre Medical Oncology	Adelaide
Australia	Fremantle Hospital	Fremantle	Western Australia
Australia	Royal Hobart Hospital	Hobart	Tasmania
Australia	Lismore Base Hospital, Cancer Care & Haematology Unit	Lismore	New South Wales
Australia	Patricia Ritchie Centre for Cancer Care and Research, Mater Hospital	North Sydney
Australia	Redcliffe Hospital	Redcliffe	Queensland
Australia	The Tweed Hospital	Tweed Heads
Australia	Newcastle Melanoma Unit - Calvary Mater Newcastle	Waratah	New South Wales
Australia	Department of Medical Oncology, Westmead Hospital	Westmead
Australia	Southern Medical Day Care Centre	Wollongong	New South Wales
Australia	Princess Alexandra Hospital	Wooloongabba	Queensland
Canada	Tom Baker Cancer Centre	Calgary	Alberta
Canada	Cross Cancer Institute	Edmonton
Canada	QE II Health Sciences Center	Halifax	Nova Scotia
Canada	Northeastern Ontario Regional Cancer Centre	Sudbury	Ontario
Canada	Princess Margaret Hospital	Toranto
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
Puerto Rico	VA Medical Center	San Juan
Romania	County Hospital Brasov - Oncology Department	Brasov
Romania	Oncology Institute "Prof. Dr. Ion Chiricuta"	Cluj Napoca
Romania	Clinical County Hospital " Alexandru Simionescu" Hunedoara	Hunedoara
Romania	Center of Medical Oncology	Iasi
Romania	Clinical County Hospital Sibiu	Sibiu
Romania	Oncology- Chemotherapy Clinic - Emergency Municipal Clinical Hospital	Timisoara
Spain	Hospital Universitario de la Princessa Servicio de Oncología Médica	Madrid
Spain	Hospital Universitario Central de Asturias	Oviedo	Asturias
Spain	Clinica Universitaria de Navarra	Pamplona
Spain	Hospital Virgen de la Salud - Servicio de Oncología Médica Ciclos	Toledo
United Kingdom	Oncology Centre Addenbrookes's Hospital	Cambridge
United Kingdom	Northern Centre for Cancer Treatment Newcastle General Hospital	Newcastle upon Tyne
United Kingdom	Dorset Cancer Centre Poole Hospital NHS Foundation Trust	Poole
United States	University of New Mexico Cancer Center	Albuquerque	New Mexico
United States	Emory University Winship Cancer Institute	Atlanta	Georgia
United States	Piedmont Hospital	Atlanta	Georgia
United States	Anschutz Cancer Pavillion University of Colorado	Aurora	Colorado
United States	Mary Bird Perkins Cancer Center	Baton Rouge	Louisiana
United States	Bay Pines VA Healthcare System	Bay Pines	Florida
United States	St. Luke's Cancer Center	Bethlehem	Pennsylvania
United States	Beth Israel Deaconess Medical Center	Boston	Massachusetts
United States	Dana Farber Cancer Institute	Boston	Massachusetts
United States	UNC School of Medicine - Division of Hematology/Oncology	Chapel Hill	North Carolina
United States	Carolina Hematology & Oncology Associates	Charlotte	North Carolina
United States	Virginia Oncology Associates	Chesapeake	Virginia
United States	Rush University Hospital	Chicago	Illinois
United States	The Christ Hospital	Cincinnati	Ohio
United States	Ellis Fischels Cancer Center	Columbia	Missouri
United States	Mark H. Zangmeister Cancer Center	Columbus	Ohio
United States	The Ohio State University.	Columbus	Ohio
United States	Texas Oncology, PA	Dallas	Texas
United States	Karmanos Cancer Institute, Wayne State University	Detroit	Michigan
United States	Duke University Medical Center	Durham	North Carolina
United States	Evanston Northwestern Healthcare	Evanston	Illinois
United States	Goshen Center for Cancer Care	Goshen	Indiana
United States	Brody School of Medicine at East Carolina State University	Greenville	North Carolina
United States	Cancer Center of the Carolinas	Greenville	South Carolina
United States	Leo W. Jenkins Cancer Center	Greenville	North Carolina
United States	Indiana University Melvin and Bren Simon Cancer Center	Indianapolis	Indiana
United States	Joliet Oncology/Hematology Associates, LTD	Joliet	Illinois
United States	University of California San Diego Moores UCSD Cancer Center	La Jolla	California
United States	University of California, San Diego	La Jolla	California
United States	Monter Cancer Center North Shore Hospital	Lake Success	New York
United States	Dartmouth Hitchcock Medical Center	Lebanon	New Hampshire
United States	Southeast Nebraska Hematology/Oncology	Lincoln	Nebraska
United States	Winthrop P. Rockefeller Cancer Institute	Little Rock	Arkansas
United States	Jonsson Comprehensive Cancer Center Univ. of California Los Angeles	Los Angeles	California
United States	The Angeles Clinic & Research Institute	Los Angeles	California
United States	Marshfield Clinic	Marshfield	Wisconsin
United States	Univ. of Miami Hospital and Clinics	Miami	Florida
United States	Atlantic Health Research - Mountainside Hospital	Montclair	New Jersey
United States	Vanderbilt Medical Center	Nashville	Tennessee
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	Virginia Oncology Associates	Newport News	Virginia
United States	Oncology Specialists, S.C.	Niles	Illinois
United States	Virginia Oncology Associates	Norfolk	Virginia
United States	Nebraska Methodist Cancer Center	Omaha	Nebraska
United States	MD Anderson Cancer Center	Orlando	Florida
United States	Oncology Specialists, SC	Park Ridge	Illinois
United States	Abramson Cancer Center at University of Pennsylvania	Philadelphia	Pennsylvania
United States	Fox Chase Cancer Center	Philadelphia	Pennsylvania
United States	Cancer Pavilion	Pittsburgh	Pennsylvania
United States	Providence Cancer Center Clinical Trials	Portland	Oregon
United States	Virginia Cancer Institute	Richmond	Virginia
United States	Hubert H. Humphrey Cancer Center	Robbinsdale	Minnesota
United States	San Antonio Cancer Institute	San Antonio	Texas
United States	Pacific Medical Center Research Institute	San Francisco	California
United States	Redwood Regional Medical Group	Santa Rosa	California
United States	Seattle Cancer Care Alliance	Seattle	Washington
United States	Hematology Oncology, P.C.	Stamford	Connecticut
United States	Stony Brook University Medical Center- Cancer Center	Stony Brook	New York
United States	Arizona Cancer Center	Tucson	Arizona
United States	Derrick L. Davis Regional Cancer Center	Winston-Salem	North Carolina

Sponsors (1)

Lead Sponsor	Collaborator
Synta Pharmaceuticals Corp.

Countries where clinical trial is conducted

United States,  Australia,  Canada,  Germany,  Puerto Rico,  Romania,  Spain,  United Kingdom, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Progression free survival		June 2009	Yes
Secondary	Overall Survival		December 2009	Yes
Secondary	Objective response rate		December 2009	Yes
Secondary	Clinical benefit rate		December 2009	No
Secondary	Duration of objective response		December 2009	No
Secondary	Safety		December 2009	Yes
Secondary	Pharmacokinetics		December 2009	No