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

Metastatic Solid Tumors Clinical Trial

Official title:

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

Clinical Trial Details — Status: Suspended

Administrative data

• NCT number: NCT00827203
• Other study ID #: 4783-11
• Status: Suspended
• Phase: Phase 1
• First received: January 20, 2009
• Last updated: March 6, 2009
• Start date: January 2009
• Est. completion date: January 2011

Study information

• Verified date: March 2009
• Source: Synta Pharmaceuticals Corp.
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Food and Drug Administration
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Suspended
• Enrollment: 30
• Est. completion date: January 2011
• Est. primary completion date: January 2011
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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 Design

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

Related Conditions & MeSH terms

• Metastatic Solid Tumors

Intervention

Drug:
• Elesclomol Sodium
Chemotherapy agent

Locations

Country	Name	City	State
United States	University of Wisconsin Paul P. Carbone Comprehensive Cancer Center	Madison	Wisconsin
United States	Mayo Clinic	Rochester	Maryland
United States	University of Texas Health Science Center, Cancer Therapy & Research Center, Institute for Drug Development	San Antonio	Texas

Sponsors (1)

Lead Sponsor	Collaborator
Synta Pharmaceuticals Corp.

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	To characterize the safety and tolerability of elesclomol sodium administered once weekly to subjects with solid tumors		Jan 2011	Yes
Primary	To determine the pharmacokinetics of elesclomol in this population when administered once weekly as a 1-hour intravenous infusion		Jan 2011	Yes
Secondary	To inform dose selection for future study using a once-a-week schedule		Jan 2011	Yes
Secondary	To evaluate anti-tumor activity in advanced solid tumors that are metastatic and unresectable		Jan 2011	Yes
Secondary	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	Yes