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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT00827203
Recruitment Status : Suspended
First Posted : January 22, 2009
Last Update Posted : March 9, 2009
Information provided by:
Synta Pharmaceuticals Corp.

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.

Condition or disease Intervention/treatment Phase
Metastatic Solid Tumors Drug: Elesclomol Sodium Phase 1

Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 30 participants
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
Study Start Date : January 2009
Estimated Primary Completion Date : January 2011
Estimated Study Completion Date : January 2011

Arm Intervention/treatment
Experimental: Cohort Drug: Elesclomol Sodium
Chemotherapy agent

Primary Outcome Measures :
  1. To characterize the safety and tolerability of elesclomol sodium administered once weekly to subjects with solid tumors [ Time Frame: Jan 2011 ]
  2. 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 :
  1. To inform dose selection for future study using a once-a-week schedule [ Time Frame: Jan 2011 ]
  2. To evaluate anti-tumor activity in advanced solid tumors that are metastatic and unresectable [ Time Frame: Jan 2011 ]
  3. 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 ]

Information from the National Library of Medicine

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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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): 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.

Responsible Party: David Hynds, Clinical Trials Manager, Synta Pharmaceuticals Identifier: NCT00827203     History of Changes
Other Study ID Numbers: 4783-11
First Posted: January 22, 2009    Key Record Dates
Last Update Posted: March 9, 2009
Last Verified: March 2009

Keywords provided by Synta Pharmaceuticals Corp.:
Elesclomol Sodium
Advanced solid tumors that are metastatic and unresectable