Elesclomol (STA-4783) With Paclitaxel Versus Paclitaxel Alone in Melanoma
This study has been terminated.
Sponsor:
Synta Pharmaceuticals Corp.
Information provided by:
Synta Pharmaceuticals Corp.
ClinicalTrials.gov Identifier:
NCT00522834
First received: August 28, 2007
Last updated: March 6, 2009
Last verified: March 2009
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Purpose
"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 | Intervention | Phase |
|---|---|---|
|
Melanoma |
Drug: Elesclomol (STA-4783) Drug: Paclitaxel |
Phase 3 |
| Study Type: | Interventional |
| Study Design: | Allocation: Randomized Endpoint Classification: Efficacy Study Intervention Model: Parallel Assignment Masking: Double Blind (Subject, Caregiver, 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) |
Resource links provided by NLM:
Further study details as provided by Synta Pharmaceuticals Corp.:
Primary Outcome Measures:
- Progression free survival [ Time Frame: June 2009 ] [ Designated as safety issue: Yes ]
Secondary Outcome Measures:
- 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 ]
| Estimated Enrollment: | 630 |
| Study Start Date: | August 2007 |
| Estimated Study Completion Date: | June 2009 |
| Estimated Primary Completion Date: | June 2009 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
|
Active Comparator: 1
Elesclomol (STA-4783) in Combination With Paclitaxel
|
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)
|
|
2
Paclitaxel alone
|
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
|
Eligibility| Ages Eligible for Study: | 18 Years and older |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
Criteria
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
Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00522834
Show 101 Study Locations
Show 101 Study LocationsSponsors and Collaborators
Synta Pharmaceuticals Corp.
More Information
No publications provided by Synta Pharmaceuticals Corp.
Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
| Responsible Party: | Vice President of Clinical Research, Synta Pharmaceuticals Corp |
| ClinicalTrials.gov Identifier: | NCT00522834 History of Changes |
| Other Study ID Numbers: | 4783-08 |
| Study First Received: | August 28, 2007 |
| Last Updated: | March 6, 2009 |
| Health Authority: | United States: Food and Drug Administration Argentina: Administracion Nacional de Medicamentos, Alimentos y Tecnologia Medica Australia: Department of Health and Ageing Therapeutic Goods Administration Belgium: Federal Agency for Medicinal Products and Health Products Brazil: National Committee of Ethics in Research Canada: Health Canada Chile: Instituto de Salud Publica de Chile Czech Republic: State Institute for Drug Control France: Afssaps - Agence française de sécurité sanitaire des produits de santé (Saint-Denis) Germany: Federal Institute for Drugs and Medical Devices Israel: Ministry of Health Italy: The Italian Medicines Agency Poland: Office for Registration of Medicinal Products, Medical Devices and Biocidal Products Romania: National Medicines Agency United Kingdom: Medicines and Healthcare Products Regulatory Agency |
Keywords provided by Synta Pharmaceuticals Corp.:
|
melanoma oncology Stage IV Metastatic Melanoma |
Additional relevant MeSH terms:
|
Melanoma Neuroendocrine Tumors Neuroectodermal Tumors Neoplasms, Germ Cell and Embryonal Neoplasms by Histologic Type Neoplasms Neoplasms, Nerve Tissue Nevi and Melanomas Paclitaxel |
Tubulin Modulators Antimitotic Agents Mitosis Modulators Molecular Mechanisms of Pharmacological Action Pharmacologic Actions Antineoplastic Agents, Phytogenic Antineoplastic Agents Therapeutic Uses |
ClinicalTrials.gov processed this record on May 23, 2013