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

This study has suspended participant recruitment.
Information provided by:
Synta Pharmaceuticals Corp. Identifier:
First received: January 20, 2009
Last updated: March 6, 2009
Last verified: March 2009
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.

Condition Intervention Phase
Metastatic Solid Tumors Drug: Elesclomol Sodium Phase 1

Study Type: Interventional
Study Design: Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: A Phase 1 Multi-Dose Dose-Escalation Study of Elesclomol Sodium, Administered Once Weekly to Subjects With Solid Tumors

Further study details as provided by Synta Pharmaceuticals Corp.:

Primary Outcome Measures:
  • To characterize the safety and tolerability of elesclomol sodium administered once weekly to subjects with solid tumors [ Time Frame: Jan 2011 ]
  • To determine the pharmacokinetics of elesclomol in this population when administered once weekly as a 1-hour intravenous infusion [ Time Frame: Jan 2011 ]

Secondary Outcome Measures:
  • To inform dose selection for future study using a once-a-week schedule [ Time Frame: Jan 2011 ]
  • To evaluate anti-tumor activity in advanced solid tumors that are metastatic and unresectable [ Time Frame: 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 [ Time Frame: Jan 2011 ]

Estimated Enrollment: 30
Study Start Date: January 2009
Estimated Study Completion Date: January 2011
Estimated Primary Completion Date: January 2011 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Cohort Drug: Elesclomol Sodium
Chemotherapy agent


Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts 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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its identifier: NCT00827203

United States, Maryland
Mayo Clinic
Rochester, Maryland, United States, 55905
United States, Texas
University of Texas Health Science Center, Cancer Therapy & Research Center, Institute for Drug Development
San Antonio, Texas, United States, 78229
United States, Wisconsin
University of Wisconsin Paul P. Carbone Comprehensive Cancer Center
Madison, Wisconsin, United States, 53792
Sponsors and Collaborators
Synta Pharmaceuticals Corp.
  More Information

Responsible Party: David Hynds, Clinical Trials Manager, Synta Pharmaceuticals Identifier: NCT00827203     History of Changes
Other Study ID Numbers: 4783-11
Study First Received: January 20, 2009
Last Updated: March 6, 2009

Keywords provided by Synta Pharmaceuticals Corp.:
Elesclomol Sodium
Advanced solid tumors that are metastatic and unresectable processed this record on September 21, 2017