Metastatic Solid Tumors
Conditions
Keywords
cancer, metastatic, Elesclomol Sodium, tumor, Advanced solid tumors that are metastatic and unresectable
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 pharmacokinetics of elesclomol and evaluate its anti-tumor activity in advanced solid tumors that are metastatic and unresectable.
Interventions
Chemotherapy agent
Sponsors
Synta Pharmaceuticals Corp.
Study design
Allocation
NON_RANDOMIZED
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| To characterize the safety and tolerability of elesclomol sodium administered once weekly to subjects with solid tumors | Jan 2011 |
| To determine the pharmacokinetics of elesclomol in this population when administered once weekly as a 1-hour intravenous infusion | Jan 2011 |
Secondary
| Measure | Time frame |
|---|---|
| To inform dose selection for future study using a once-a-week schedule | Jan 2011 |
| To evaluate anti-tumor activity in advanced solid tumors that are metastatic and unresectable | Jan 2011 |
| To assess the effect of elesclomol sodium on the development of peripheral neuropathy by rating sensory symptoms, strength, tendon reflexes, and vibratory sense | Jan 2011 |
Countries
United States
Outcome results
None listed