Melanoma
Conditions
Keywords
melanoma, oncology, Stage IV Metastatic Melanoma
Brief summary
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.
Interventions
DRUGElesclomol (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
DRUGPaclitaxel
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
Sponsors
Synta Pharmaceuticals Corp.
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Progression free survival | June 2009 |
Secondary
| Measure | Time frame |
|---|---|
| Objective response rate | December 2009 |
| Clinical benefit rate | December 2009 |
| Overall Survival | December 2009 |
| Safety | December 2009 |
| Pharmacokinetics | December 2009 |
| Duration of objective response | December 2009 |
Countries
Australia, Canada, Germany, Puerto Rico, Romania, Spain, United Kingdom, United States
Outcome results
None listed