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


Phase 1
18 Years
N/A
Not Enrolling
Both
Metastatic Solid Tumors

Thank you

Trial Information

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

Inclusion 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

Type of Study:

Interventional

Study Design:

Allocation: Non-Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Outcome Measure:

To characterize the safety and tolerability of elesclomol sodium administered once weekly to subjects with solid tumors

Outcome Time Frame:

Jan 2011

Safety Issue:

Yes

Authority:

United States: Food and Drug Administration

Study ID:

4783-11

NCT ID:

NCT00827203

Start Date:

January 2009

Completion Date:

January 2011

Related Keywords:

  • Metastatic Solid Tumors
  • cancer
  • metastatic
  • Elesclomol Sodium
  • tumor
  • Advanced solid tumors that are metastatic and unresectable
  • Neoplasms

Name

Location

University of Wisconsin Paul P. Carbone Comprehensive Cancer CenterMadison, Wisconsin  53792-6164
Mayo ClinicRochester, Maryland  55905
University of Texas Health Science Center, Cancer Therapy & Research Center, Institute for Drug DevelopmentSan Antonio, Texas  78229