A Safety Study to Determine the Maximum Tolerated Dose of Elesclomol Sodium in Patients With Solid Tumors
NCT ID: NCT00827203
Last Updated: 2009-03-09
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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SUSPENDED
PHASE1
30 participants
INTERVENTIONAL
2009-01-31
2011-01-31
Brief Summary
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Detailed Description
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Conditions
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Study Design
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NON_RANDOMIZED
SINGLE_GROUP
TREATMENT
NONE
Study Groups
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Cohort
Elesclomol Sodium
Chemotherapy agent
Interventions
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Elesclomol Sodium
Chemotherapy agent
Eligibility Criteria
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Inclusion Criteria
* Histologically- or cytologically- confirmed solid tumor (except melanoma) that is metastatic or unresectable
* Advanced or metastatic cancer for which no standard therapy exists or that has progressed despite standard therapy
* Acceptable organ and marrow function during the Screening Period as defined by the protocol.
* Reliable venous access suitable for weekly study drug infusions
* Willingness and ability to comply with scheduled visits, treatment plans, laboratory tests, and other study procedures
Exclusion Criteria
* Have had chemotherapy or radiotherapy within 4 weeks prior to entering the study
* Primary brain tumors or active brain metastases
* Treatment with chronic immunosuppressants
* Significant cardiovascular disease, severe acute/chronic medical or psychiatric condition, or laboratory abnormality that may increase the risk associated with study participation or study drug administration
18 Years
ALL
No
Sponsors
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Synta Pharmaceuticals Corp.
INDUSTRY
Responsible Party
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Synta Pharmaceuticals
Locations
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Mayo Clinic
Rochester, Maryland, United States
University of Texas Health Science Center, Cancer Therapy & Research Center, Institute for Drug Development
San Antonio, Texas, United States
University of Wisconsin Paul P. Carbone Comprehensive Cancer Center
Madison, Wisconsin, United States
Countries
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Other Identifiers
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4783-11
Identifier Type: -
Identifier Source: org_study_id
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