Trial Information
Indication: Metastatic Melanoma
Study Summary: Elesclomol (STA-4783) With Paclitaxel versus Paclitaxel Alone in Melanoma
Elesclomol (STA-4783), N-malonyl-bis (N’-methyl-N’-thiobenzoylhydrazide) is a new chemical entity with a novel structure. Elesclomol (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 Elesclomol (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.
Major Inclusion Criteria (Potential study participants must meet the following 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
Major Exclusion Criteria (Potential study participants will not be eligible with the following):
- 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
For more information call 87-SYMMETRY ( 877-966-3879).
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