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

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:

MedlinePlus related topics: Melanoma

Drug Information available for: Xylometazoline Xylometazoline hydrochloride Paclitaxel

Genetic and Rare Diseases Information Center resources: Carcinoid Tumor Neuroepithelioma

U.S. FDA Resources

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
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 (Adult, Senior)
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

Show 101 Study Locations

Sponsors and Collaborators

Synta Pharmaceuticals Corp.

More Information

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

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.


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 Albumin-Bound Paclitaxel Antineoplastic Agents, Phytogenic Antineoplastic Agents Tubulin Modulators Antimitotic Agents Mitosis Modulators Molecular Mechanisms of Pharmacological Action

ClinicalTrials.gov processed this record on September 27, 2016