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

March 6, 2009 updated by: Synta Pharmaceuticals Corp.

A Phase 1 Multi-Dose Dose-Escalation Study of Elesclomol Sodium, Administered Once Weekly to Subjects With Solid Tumors

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.

Study Overview

Status

Suspended

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Anticipated)

30

Phase

  • Phase 1

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Maryland
      • Rochester, Maryland, United States, 55905
        • Mayo Clinic
    • Texas
      • San Antonio, Texas, United States, 78229
        • University of Texas Health Science Center, Cancer Therapy & Research Center, Institute for Drug Development
    • Wisconsin
      • Madison, Wisconsin, United States, 53792
        • University of Wisconsin Paul P. Carbone Comprehensive Cancer Center

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Non-Randomized
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Cohort
Drug: Elesclomol Sodium
Chemotherapy agent

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
To characterize the safety and tolerability of elesclomol sodium administered once weekly to subjects with solid tumors
Time Frame: Jan 2011
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
Jan 2011

Secondary Outcome Measures

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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Synta Pharmaceuticals Corp.

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

January 1, 2009

Primary Completion (Anticipated)

January 1, 2011

Study Completion (Anticipated)

January 1, 2011

Study Registration Dates

First Submitted

January 20, 2009

First Submitted That Met QC Criteria

January 21, 2009

First Posted (Estimate)

January 22, 2009

Study Record Updates

Last Update Posted (Estimate)

March 9, 2009

Last Update Submitted That Met QC Criteria

March 6, 2009

Last Verified

March 1, 2009

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 4783-11

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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