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

NCT00827203 | Suspended Phase 1

• 1 other identifier: 4783-11
• Study Type: interventional
• Target: 30
• Locations: 1 country
• Sites: 3

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.

Conditions

Metastatic Solid Tumors

Keywords

cancer; metastatic; Elesclomol Sodium; tumor; Advanced solid tumors that are metastatic and unresectable

Outcome Measures

Primary Outcomes (2)

• 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 Outcomes (3)

• 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

Study Arms (1)

Cohort

EXPERIMENTAL

Drug: Elesclomol Sodium

Interventions

Elesclomol Sodium DRUG

Chemotherapy agent

Cohort

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Synta Pharmaceuticals Corp.: lead

Study Sites (3)

Mayo Clinic

Rochester, Maryland, 55905, United States

Location

University of Texas Health Science Center, Cancer Therapy & Research Center, Institute for Drug Development

San Antonio, Texas, 78229, United States

Location

University of Wisconsin Paul P. Carbone Comprehensive Cancer Center

Madison, Wisconsin, 53792, United States

Location

MeSH Terms

Conditions

Neoplasms; Neoplasm Metastasis

Condition Hierarchy (Ancestors)

Neoplastic Processes; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY

Study Record Dates

• First Submitted: January 20, 2009
• First Posted: January 22, 2009
• Study Start: January 1, 2009
• Primary Completion: January 1, 2011
• Study Completion: January 1, 2011
• Last Updated: March 9, 2009

Record last verified: 2009-03

Locations

US (3)