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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT00522834
Recruitment Status : Terminated
First Posted : August 30, 2007
Last Update Posted : March 4, 2014
Information provided by (Responsible Party):
Synta Pharmaceuticals Corp.

August 28, 2007
August 30, 2007
March 4, 2014
August 2007
June 2009   (Final data collection date for primary outcome measure)
Progression free survival [ Time Frame: June 2009 ]
Progression free survival
Complete list of historical versions of study NCT00522834 on Archive Site
  • Overall Survival [ Time Frame: December 2009 ]
  • Objective response rate [ Time Frame: December 2009 ]
  • Clinical benefit rate [ Time Frame: December 2009 ]
  • Duration of objective response [ Time Frame: December 2009 ]
  • Safety [ Time Frame: December 2009 ]
  • Pharmacokinetics [ Time Frame: December 2009 ]
  • Overall Survival
  • Objective response rate
  • Clinical benefit rate
  • Duration of objective response
  • Safety
  • Pharmacokinetics
Not Provided
Not Provided
Elesclomol (STA-4783) With Paclitaxel Versus Paclitaxel Alone in Melanoma
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. "

Not Provided
Phase 3
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
  • 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
  • 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
  • Active Comparator: 1
    Elesclomol (STA-4783) in Combination With Paclitaxel
    Intervention: Drug: Elesclomol (STA-4783)
  • 2
    Paclitaxel alone
    Intervention: Drug: Paclitaxel
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.

*   Includes publications given by the data provider as well as publications identified by Identifier (NCT Number) in Medline.
Not Provided
June 2009
June 2009   (Final data collection date for primary outcome measure)

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
Sexes Eligible for Study: All
18 Years and older   (Adult, Senior)
Contact information is only displayed when the study is recruiting subjects
Australia,   Canada,   Germany,   Puerto Rico,   Romania,   Spain,   United Kingdom,   United States
Not Provided
Not Provided
Synta Pharmaceuticals Corp.
Synta Pharmaceuticals Corp.
Not Provided
Not Provided
Synta Pharmaceuticals Corp.
January 2014

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP