Status:
SUSPENDED
A Safety Study to Determine the Maximum Tolerated Dose of Elesclomol Sodium in Patients With Solid Tumors
Lead Sponsor:
Synta Pharmaceuticals Corp.
Conditions:
Metastatic Solid Tumors
Eligibility:
All Genders
18+ years
Phase:
PHASE1
Brief Summary
The aim of this study is to determine the safety and tolerability of elesclomol sodium at escalating doses (ultimately identifying the maximum tolerated dose). This study will also characterize the ph...
Eligibility Criteria
Inclusion
- Inclusion Criteria
- Males and females at least 18 years of age
- 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
- Pregnant or breast-feeding women
- 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
Exclusion
Key Trial Info
Start Date :
January 1 2009
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
January 1 2011
Estimated Enrollment :
30 Patients enrolled
Trial Details
Trial ID
NCT00827203
Start Date
January 1 2009
End Date
January 1 2011
Last Update
March 9 2009
Active Locations (3)
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1
Mayo Clinic
Rochester, Maryland, United States, 55905
2
University of Texas Health Science Center, Cancer Therapy & Research Center, Institute for Drug Development
San Antonio, Texas, United States, 78229
3
University of Wisconsin Paul P. Carbone Comprehensive Cancer Center
Madison, Wisconsin, United States, 53792