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

This study has been terminated.
Sponsor:
Information provided by (Responsible Party):
Synta Pharmaceuticals Corp.
ClinicalTrials.gov Identifier:
NCT00522834
First received: August 28, 2007
Last updated: January 31, 2014
Last verified: January 2014

August 28, 2007
January 31, 2014
August 2007
June 2009   (final data collection date for primary outcome measure)
Progression free survival [ Time Frame: June 2009 ] [ Designated as safety issue: Yes ]
Progression free survival
Complete list of historical versions of study NCT00522834 on ClinicalTrials.gov Archive Site
  • 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 ]
  • 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
Interventional
Phase 3
Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Melanoma
  • 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 Name: Elesclomol (STA-4783)
  • 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 ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Terminated
630
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
Both
18 Years and older
No
Contact information is only displayed when the study is recruiting subjects
United States,   Romania,   Spain,   Canada,   Australia,   United Kingdom,   Germany,   Puerto Rico
 
NCT00522834
4783-08
Yes
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