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Melanoma

A Randomized, Double-blind, Phase 3 Trial of STA-4783 in Combination with Paclitaxel versus Paclitaxel Alone for Treatment of Chemotherapy-Naive Subjects with Stage IV Metastatic Melanoma (SYMMETRY)

Unique Data Set IDMelanom_SyntaPh_2007_123
DownloadableYes
SponsorSynta PharmaceuticalsData ProviderSyntaTotal Study Enrolled Patients651Comparator (Control) Arm Enrolled Patients326RandomizationYesClinicalTrial.gov IDNCT00522834ClinicalTrial.gov URLhttps://clinicaltrials.gov/ct2/show/NCT00522834?term=Synta+Pharmaceuticals&rank=12
Study PhaseClinical Study Phase IIIBlinding MethodDouble-BlindedType(s) of dataOnly comparator arm dataIntervention TypeDrugData Set TypeOther

Clinical Trial Title

A Randomized, Double-blind, Phase 3 Trial of STA-4783 in Combination with Paclitaxel versus Paclitaxel Alone for Treatment of Chemotherapy-Naive Subjects with Stage IV Metastatic Melanoma (SYMMETRY)

Trial Summary and Conditions

Design 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. Approximately 630 subjects will be enrolled. Subjects will be prospectively stratified using screening evaluations by: - M1-class (M1a or M1b vs. M1c with elevated LDH vs. M1c with normal LDH) - Prior permitted systemic treatment for melanoma as defined in inclusion number 9 (No prior treatment vs. Prior treatment resulting in discontinuation due to disease progressiprogression vs. Prior treatment resulting in discontinuation for a reason other than disease progression [eg, intolerance]) 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. Crossover to the STA-4783/paclitaxel arm is not allowed on this study. Rationale for use of Paclitaxel Given the comparable efficacy data, paclitaxel is preferred as the active comparator in this study for a number of reasons. First, given that STA-4783 is only administered in combination with paclitaxel, the paclitaxel control allows the study to be blinded, thus increasing the rigor of the design. Second, this control will allow the best categorization of the safety profile of STA-4783 in combination with paclitaxel as compared to paclitaxel alone.

Data Summary

Control Arm Raw Data

Study Objectives

Primary 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

Outcome Measures

Primary - Progression-free survival (PFS). Secondary Objectives - overall survival (OS) - objective response rate (ORR) - clinical benefit rate (proportion of subjects who have CR or PR, or SD for at least 24 weeks) -duration of objective response

Available Downloads:

To gain access to the data and analytic tools click here.

PROTOCOL: Redacted Synta 4783-08 Protocol (PDS).pdf

CRF: Synta_4783_08_aCRF_final_version_3_CRF_Final_version_2.pdf

DATA DICTIONARY: Data_dictionary.xlsx

DATA (COMPARATOR ARM): ae.sas7bdat

DATA (COMPARATOR ARM): aeae.sas7bdat

DATA (COMPARATOR ARM): bdos.sas7bdat

DATA (COMPARATOR ARM): cm.sas7bdat

DATA (COMPARATOR ARM): cmcm.sas7bdat

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

DATA (COMPARATOR ARM): master.sas7bdat

DATA (COMPARATOR ARM): mh.sas7bdat

DATA (COMPARATOR ARM): mhmh.sas7bdat

DATA (COMPARATOR ARM): ms.sas7bdat

DATA (COMPARATOR ARM): pe.sas7bdat

DATA (COMPARATOR ARM): pepe.sas7bdat

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

DATA (COMPARATOR ARM): radrad.sas7bdat

DATA (COMPARATOR ARM): rsp.sas7bdat

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