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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)

Phase 3
18 Years
Not Enrolling

Thank you

Trial Information

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)

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

Type of Study:


Study Design:

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

Outcome Measure:

Progression free survival

Outcome Time Frame:

June 2009

Safety Issue:



United States: Food and Drug Administration

Study ID:




Start Date:

August 2007

Completion Date:

June 2009

Related Keywords:

  • Melanoma
  • melanoma
  • oncology
  • Stage IV Metastatic Melanoma
  • Melanoma



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