Clinical trial NCT00827203: A Safety Study to Determine the Maximum Tolerated Dose of Elesclomol Sodium in Patients With Solid Tumors
Official title: A Phase 1 Multi-Dose Dose-Escalation Study of Elesclomol Sodium, Administered Once Weekly to Subjects With Solid Tumors
Study type: INTERVENTIONAL
Overall status: SUSPENDED
Phase: PHASE1
Conditions: Metastatic Solid Tumors
Keywords: cancer
metastatic
Elesclomol Sodium
tumor
Advanced solid tumors that are metastatic and unresectable
Lead sponsor: Synta Pharmaceuticals Corp.
Sponsor class: INDUSTRY
First posted: 2009-01-22
Enrollment: 30
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

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.


Eligibility 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

Primary outcomes:
measure: To characterize the safety and tolerability of elesclomol sodium administered once weekly to subjects with solid tumors
timeFrame: Jan 2011
measure: To determine the pharmacokinetics of elesclomol in this population when administered once weekly as a 1-hour intravenous infusion
timeFrame: Jan 2011
Secondary outcomes:
measure: To inform dose selection for future study using a once-a-week schedule
timeFrame: Jan 2011
measure: To evaluate anti-tumor activity in advanced solid tumors that are metastatic and unresectable
timeFrame: Jan 2011
measure: To assess the effect of elesclomol sodium on the development of peripheral neuropathy by rating sensory symptoms, strength, tendon reflexes, and vibratory sense
timeFrame: Jan 2011
Other outcomes:
Locations:
city: Rochester
country: United States
facility: Mayo Clinic
state: Maryland
city: San Antonio
country: United States
facility: University of Texas Health Science Center, Cancer Therapy & Research Center, Institute for Drug Development
state: Texas
city: Madison
country: United States
facility: University of Wisconsin Paul P. Carbone Comprehensive Cancer Center
state: Wisconsin
Study officials:
References: