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Type(s) of Cancer
Melanoma

Study Phase

Phase 3

Study Completion Date
June 2009

NCT00522834Uploaded 03-26-2015

Available for Download

PDS UID: Melanom_SyntaPh_2007_123

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)

Provider Information

Provider Data DescriptionPrimary The primary objective is to assess the efficacy of STA-4783 in combination with paclitaxel in comparison with paclitaxel alone, based on progression-free survival (PFS). Secondary Objectives To assess overall survival (OS) To assess the objective response rate (ORR) ? To assess the clinical benefit rate (proportion of subjects who have CR or PR, or SD for at least 24 weeks) To assess the duration of objective response To further characterize the safety of STA-4783 in combination with paclitaxel in comparison with paclitaxel alone To further characterize the pharmacokinetics of STA-4783 in combination with paclitaxel Exploratory To assess the pharmacodynamics of STA-4783

SponsorSynta Pharmaceuticals

Data ProviderSynta

Partial set or SubsetOriginal Data

Patients in dataset651

# of Patients Control326

# of Patients ExperimentalN/A

DOIhttps://doi.org/10.34949/k3fh-3e18

CDISC StandardRaw

Study ArmsComparator arm data only

Clinical Trials.gov Information

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. "

ConditionsMelanoma

Intervention TypeDrug: Elesclomol (STA-4783)
Drug: Paclitaxel

Drug(s)Drug: Elesclomol (STA-4783)
Drug: Paclitaxel

Total Enrolled630

RandomizationRandomized

Blinding MethodQuadruple

Arms Intervention1 - Active Comparator
2 - Other

Secondary IDN/A

PubMed (PMID)23401447

Collaborator(s)N/A

Region(s)United States
Australia
Canada
Germany
Puerto Rico
Romania
Spain
United Kingdom

Age Range18 Years and older (Adult, Older Adult)

Files:

PROTOCOLRedacted Synta 4783-08 Protocol (PDS).pdf

CRFSynta_4783_08_aCRF_final_version_3_CRF_Final_version_2.pdf

DATA DICTIONARYData_dictionary.xlsx

DATA (COMPARATOR ARM)ae.sas7bdat

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DATA (COMPARATOR ARM)dm.sas7bdat

DATA (COMPARATOR ARM)ds.sas7bdat

DATA (COMPARATOR ARM)ec.sas7bdat

DATA (COMPARATOR ARM)eg.sas7bdat

DATA (COMPARATOR ARM)exc.sas7bdat

DATA (COMPARATOR ARM)im.sas7bdat

DATA (COMPARATOR ARM)inc.sas7bdat

DATA (COMPARATOR ARM)invs.sas7bdat

DATA (COMPARATOR ARM)labd.sas7bdat

DATA (COMPARATOR ARM)labdllab.sas7bdat

DATA (COMPARATOR ARM)les.sas7bdat

DATA (COMPARATOR ARM)lesles.sas7bdat

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DATA (COMPARATOR ARM)mhmh.sas7bdat

DATA (COMPARATOR ARM)ms.sas7bdat

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DATA (COMPARATOR ARM)pkd.sas7bdat

DATA (COMPARATOR ARM)pkdpkd.sas7bdat

DATA (COMPARATOR ARM)plog.sas7bdat

DATA (COMPARATOR ARM)plogplog.sas7bdat

DATA (COMPARATOR ARM)qexc.sas7bdat

DATA (COMPARATOR ARM)qtc.sas7bdat

DATA (COMPARATOR ARM)qtceg.sas7bdat

DATA (COMPARATOR ARM)rad.sas7bdat

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DATA (COMPARATOR ARM)srv.sas7bdat

DATA (COMPARATOR ARM)tmr.sas7bdat

DATA (COMPARATOR ARM)tmrphto.sas7bdat

DATA (COMPARATOR ARM)vdt.sas7bdat

DATA (COMPARATOR ARM)vs.sas7bdat

DATA (COMPARATOR ARM)vsvs.sas7bdat

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