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

Synta Pharmaceuticals

Status and phase

Suspended

Phase 1

Conditions

Metastatic Solid Tumors

Treatments

Drug: Elesclomol Sodium

Study type

Interventional

Funder types

Industry

Identifiers

NCT00827203

4783-11

Details and patient eligibility

About

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.

Enrollment

30 estimated patients

Sex

All

Ages

18+ years old

Volunteers

No Healthy Volunteers

Inclusion and exclusion 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