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Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/show/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
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)
Secondary ID [1] 0 0
4783-08
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Melanoma 0 0
Condition category
Condition code
Cancer 0 0 0 0
Malignant melanoma

Intervention/exposure
Study type
Interventional
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

Intervention code [1] 0 0
Treatment: Drugs
Comparator / control treatment
Control group

Outcomes
Primary outcome [1] 0 0
Progression free survival
Timepoint [1] 0 0
June 2009
Secondary outcome [1] 0 0
Overall Survival
Timepoint [1] 0 0
December 2009
Secondary outcome [2] 0 0
Objective response rate
Timepoint [2] 0 0
December 2009
Secondary outcome [3] 0 0
Clinical benefit rate
Timepoint [3] 0 0
December 2009
Secondary outcome [4] 0 0
Duration of objective response
Timepoint [4] 0 0
December 2009
Secondary outcome [5] 0 0
Safety
Timepoint [5] 0 0
December 2009
Secondary outcome [6] 0 0
Pharmacokinetics
Timepoint [6] 0 0
December 2009

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
Minimum age
18 Years
Maximum age
No limit
Gender
Both males and females
Can healthy volunteers participate?
No
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

Study design
Purpose of the study
Treatment
Allocation to intervention
Randomised controlled trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Masking / blinding
Blinded (masking used)
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
Intervention assignment
Parallel
Other design features
Phase
Phase 3
Type of endpoint(s)
Statistical methods / analysis

Recruitment
Recruitment status
Terminated
Data analysis
Reason for early stopping/withdrawal
Other reasons
Date of first participant enrolment
Anticipated
Actual
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
NSW,QLD,TAS,WA
Recruitment hospital [1] 0 0
Lismore Base Hospital, Cancer Care & Haematology Unit - Lismore
Recruitment hospital [2] 0 0
Newcastle Melanoma Unit - Calvary Mater Newcastle - Waratah
Recruitment hospital [3] 0 0
Southern Medical Day Care Centre - Wollongong
Recruitment hospital [4] 0 0
Redcliffe Hospital - Redcliffe
Recruitment hospital [5] 0 0
Princess Alexandra Hospital - Wooloongabba
Recruitment hospital [6] 0 0
Royal Hobart Hospital - Hobart
Recruitment hospital [7] 0 0
Fremantle Hospital - Fremantle
Recruitment hospital [8] 0 0
Royal Adelaide Cancer Centre Medical Oncology - Adelaide
Recruitment hospital [9] 0 0
Patricia Ritchie Centre for Cancer Care and Research, Mater Hospital - North Sydney
Recruitment hospital [10] 0 0
The Tweed Hospital - Tweed Heads
Recruitment hospital [11] 0 0
Department of Medical Oncology, Westmead Hospital - Westmead
Recruitment postcode(s) [1] 0 0
- Lismore
Recruitment postcode(s) [2] 0 0
2298 - Waratah
Recruitment postcode(s) [3] 0 0
2500 - Wollongong
Recruitment postcode(s) [4] 0 0
4020 - Redcliffe
Recruitment postcode(s) [5] 0 0
4102 - Wooloongabba
Recruitment postcode(s) [6] 0 0
- Hobart
Recruitment postcode(s) [7] 0 0
6160 - Fremantle
Recruitment postcode(s) [8] 0 0
SA 5000 - Adelaide
Recruitment postcode(s) [9] 0 0
- North Sydney
Recruitment postcode(s) [10] 0 0
- Tweed Heads
Recruitment postcode(s) [11] 0 0
- Westmead
Recruitment outside Australia
Country [1] 0 0
United States of America
State/province [1] 0 0
Arizona
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United States of America
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Arkansas
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California
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Colorado
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Connecticut
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Florida
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United States of America
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Georgia
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United States of America
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Illinois
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United States of America
State/province [9] 0 0
Indiana
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United States of America
State/province [10] 0 0
Louisiana
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United States of America
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Massachusetts
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Michigan
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Minnesota
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Missouri
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United States of America
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Nebraska
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United States of America
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New Hampshire
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United States of America
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New Jersey
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United States of America
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New Mexico
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United States of America
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New York
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United States of America
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North Carolina
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Ohio
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Oregon
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Pennsylvania
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South Carolina
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Tennessee
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Texas
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Virginia
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Washington
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United States of America
State/province [29] 0 0
Wisconsin
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Canada
State/province [30] 0 0
Alberta
Country [31] 0 0
Canada
State/province [31] 0 0
Nova Scotia
Country [32] 0 0
Canada
State/province [32] 0 0
Ontario
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Canada
State/province [33] 0 0
Edmonton
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Canada
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Toranto
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Germany
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Berlin
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Germany
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Buxtehude
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Germany
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Frankfurt/Main
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Germany
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Kiel
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Germany
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Köln
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Germany
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Leipzig
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Germany
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Mannheim
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Germany
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Münster
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Germany
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Würzburg
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Puerto Rico
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San Juan
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Romania
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Brasov
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Romania
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Cluj Napoca
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Romania
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Hunedoara
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Romania
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Iasi
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Romania
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Sibiu
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Romania
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Timisoara
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Spain
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Asturias
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Spain
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Madrid
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Spain
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Pamplona
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Spain
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Toledo
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United Kingdom
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Cambridge
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United Kingdom
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Newcastle upon Tyne
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United Kingdom
State/province [57] 0 0
Poole

Funding & Sponsors
Primary sponsor type
Commercial sector/Industry
Name
Synta Pharmaceuticals Corp.
Address
Country

Ethics approval
Ethics application status

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. "
Trial website
https://clinicaltrials.gov/show/NCT00522834
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 0 0
Address 0 0
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for public queries
Name 0 0
Address 0 0
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for scientific queries

Summary results
For IPD and results data, please see https://clinicaltrials.gov/show/NCT00522834