Elesclomol (STA-4783) With Paclitaxel Versus Paclitaxel Alone in Melanoma
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| ClinicalTrials.gov Identifier: NCT00522834 |
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Recruitment Status :
Terminated
First Posted : August 30, 2007
Last Update Posted : March 4, 2014
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"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. "
| Condition or disease | Intervention/treatment | Phase |
|---|---|---|
| Melanoma | Drug: Elesclomol (STA-4783) Drug: Paclitaxel | Phase 3 |
| Study Type : | Interventional (Clinical Trial) |
| Actual Enrollment : | 630 participants |
| Allocation: | Randomized |
| Intervention Model: | Parallel Assignment |
| Masking: | Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor) |
| Primary Purpose: | Treatment |
| Official Title: | 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) |
| Study Start Date : | August 2007 |
| Actual Primary Completion Date : | June 2009 |
| Actual Study Completion Date : | June 2009 |
| Arm | Intervention/treatment |
|---|---|
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Active Comparator: 1
Elesclomol (STA-4783) in Combination With Paclitaxel
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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
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2
Paclitaxel alone
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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
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- Progression free survival [ Time Frame: June 2009 ]
- 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 ]
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| Ages Eligible for Study: | 18 Years and older (Adult, Senior) |
| Sexes Eligible for Study: | All |
| Accepts 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
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00522834
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Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
| Responsible Party: | Synta Pharmaceuticals Corp. |
| ClinicalTrials.gov Identifier: | NCT00522834 History of Changes |
| Other Study ID Numbers: |
4783-08 |
| First Posted: | August 30, 2007 Key Record Dates |
| Last Update Posted: | March 4, 2014 |
| Last Verified: | January 2014 |
Keywords provided by Synta Pharmaceuticals Corp.:
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melanoma oncology Stage IV Metastatic Melanoma |
Additional relevant MeSH terms:
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Melanoma Neuroendocrine Tumors Neuroectodermal Tumors Neoplasms, Germ Cell and Embryonal Neoplasms by Histologic Type Neoplasms Neoplasms, Nerve Tissue Nevi and Melanomas |
Paclitaxel Albumin-Bound Paclitaxel Antineoplastic Agents, Phytogenic Antineoplastic Agents Tubulin Modulators Antimitotic Agents Mitosis Modulators Molecular Mechanisms of Pharmacological Action |