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Trial details imported from ClinicalTrials.gov
For full trial details, please see the original record at
https://clinicaltrials.gov/study/NCT00522834
Registration number
NCT00522834
Ethics application status
Date submitted
28/08/2007
Date registered
30/08/2007
Date last updated
4/03/2014
Titles & IDs
Public title
Elesclomol (STA-4783) With Paclitaxel Versus Paclitaxel Alone in Melanoma
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Scientific 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)
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Secondary ID [1]
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4783-08
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Universal Trial Number (UTN)
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Trial acronym
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Linked study record
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Health condition
Health condition(s) or problem(s) studied:
Melanoma
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Condition category
Condition code
Cancer
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Malignant melanoma
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Intervention/exposure
Study type
Interventional
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Description of intervention(s) / exposure
Treatment: Drugs - Elesclomol (STA-4783)
Treatment: Drugs - Paclitaxel
Active comparator: 1 - Elesclomol (STA-4783) in Combination With Paclitaxel
Other: 2 - Paclitaxel alone
Treatment: Drugs: 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
Treatment: Drugs: 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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Intervention code [1]
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Treatment: Drugs
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Comparator / control treatment
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Control group
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Outcomes
Primary outcome [1]
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Progression free survival
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Assessment method [1]
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Timepoint [1]
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June 2009
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Secondary outcome [1]
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Overall Survival
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Assessment method [1]
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Timepoint [1]
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December 2009
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Secondary outcome [2]
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Objective response rate
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Assessment method [2]
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Timepoint [2]
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December 2009
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Secondary outcome [3]
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Clinical benefit rate
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December 2009
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Secondary outcome [4]
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Duration of objective response
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December 2009
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Safety
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Timepoint [5]
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December 2009
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Secondary outcome [6]
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Pharmacokinetics
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Assessment method [6]
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Timepoint [6]
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December 2009
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Eligibility
Key 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
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Minimum age
18
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Maximum age
No limit
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Sex
Both males and females
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Can healthy volunteers participate?
No
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Key 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
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Study design
Purpose of the study
Treatment
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Allocation to intervention
Randomised controlled trial
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Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
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Methods used to generate the sequence in which subjects will be randomised (sequence generation)
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Masking / blinding
Blinded (masking used)
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Who is / are masked / blinded?
The people receiving the treatment/s
The people administering the treatment/s
The people assessing the outcomes
The people analysing the results/data
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Intervention assignment
Parallel
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Other design features
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Phase
Phase 3
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Type of endpoint/s
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Statistical methods / analysis
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Recruitment
Recruitment status
Stopped early
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Data analysis
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Reason for early stopping/withdrawal
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Other reasons
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Date of first participant enrolment
Anticipated
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Actual
1/08/2007
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Date of last participant enrolment
Anticipated
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Actual
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Date of last data collection
Anticipated
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Actual
1/06/2009
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Sample size
Target
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Accrual to date
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Final
630
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Recruitment in Australia
Recruitment state(s)
NSW,QLD,TAS,WA
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Recruitment hospital [1]
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Lismore Base Hospital, Cancer Care & Haematology Unit - Lismore
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Recruitment hospital [2]
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Newcastle Melanoma Unit - Calvary Mater Newcastle - Waratah
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Southern Medical Day Care Centre - Wollongong
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Redcliffe Hospital - Redcliffe
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Princess Alexandra Hospital - Wooloongabba
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Royal Hobart Hospital - Hobart
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Fremantle Hospital - Fremantle
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Royal Adelaide Cancer Centre Medical Oncology - Adelaide
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Patricia Ritchie Centre for Cancer Care and Research, Mater Hospital - North Sydney
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The Tweed Hospital - Tweed Heads
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Recruitment hospital [11]
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Department of Medical Oncology, Westmead Hospital - Westmead
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Recruitment postcode(s) [1]
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- Lismore
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Recruitment postcode(s) [2]
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2298 - Waratah
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2500 - Wollongong
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Recruitment postcode(s) [4]
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4020 - Redcliffe
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Recruitment postcode(s) [5]
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4102 - Wooloongabba
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- Hobart
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6160 - Fremantle
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Recruitment postcode(s) [8]
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SA 5000 - Adelaide
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- North Sydney
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- Tweed Heads
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Recruitment postcode(s) [11]
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- Westmead
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Recruitment outside Australia
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Arizona
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Poole
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Funding & Sponsors
Primary sponsor type
Commercial sector/industry
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Name
Synta Pharmaceuticals Corp.
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Ethics approval
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Summary
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. "
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Trial website
https://clinicaltrials.gov/study/NCT00522834
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Trial related presentations / publications
O'Day SJ, Eggermont AM, Chiarion-Sileni V, Kefford R, Grob JJ, Mortier L, Robert C, Schachter J, Testori A, Mackiewicz J, Friedlander P, Garbe C, Ugurel S, Collichio F, Guo W, Lufkin J, Bahcall S, Vukovic V, Hauschild A. Final results of phase III SYMMETRY study: randomized, double-blind trial of elesclomol plus paclitaxel versus paclitaxel alone as treatment for chemotherapy-naive patients with advanced melanoma. J Clin Oncol. 2013 Mar 20;31(9):1211-8. doi: 10.1200/JCO.2012.44.5585. Epub 2013 Feb 11.
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Public notes
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Contacts
Principal investigator
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Contact person for scientific queries
No information has been provided regarding IPD availability
What supporting documents are/will be available?
No Supporting Document Provided
Results publications and other study-related documents
No documents have been uploaded by study researchers.
Results not provided in
https://clinicaltrials.gov/study/NCT00522834
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