A Safety Study to Determine the Maximum Tolerated Dose of Elesclomol Sodium in Patients With Solid Tumors

• Status: Suspended
• Trial end date: 2011-01-01
• Target enrollment: 0
• Participant gender: All

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 pharmacokinetics of elesclomol and evaluate its anti-tumor activity in advanced solid tumors that are metastatic and unresectable.

• Phase: Phase 1
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Synta Pharmaceuticals Corp.

Criteria

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