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

Sponsored by:	Synta Pharmaceuticals, Corp.
Information provided by:	Synta Pharmaceuticals, Corp.
ClinicalTrials.gov Identifier:	NCT00827203

Purpose

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 I

Study Type:	Interventional
Study Design:	Treatment, Non-Randomized, Open Label, Single Group Assignment, Safety/Efficacy Study
Official Title:	A Phase 1 Multi-Dose Dose-Escalation Study of Elesclomol Sodium, Administered Once Weekly to Subjects With Solid Tumors

Resource links provided by NLM:

MedlinePlus related topics: Cancer

U.S. FDA Resources

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 ] [ Designated as safety issue: Yes ]
To determine the pharmacokinetics of elesclomol in this population when administered once weekly as a 1-hour intravenous infusion [ Time Frame: Jan 2011 ] [ Designated as safety issue: Yes ]

Secondary Outcome Measures:

To inform dose selection for future study using a once-a-week schedule [ Time Frame: Jan 2011 ] [ Designated as safety issue: Yes ]
To evaluate anti-tumor activity in advanced solid tumors that are metastatic and unresectable [ Time Frame: Jan 2011 ] [ Designated as safety issue: Yes ]
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 ] [ Designated as safety issue: Yes ]

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
Cohort: Experimental	Drug: Elesclomol Sodium Chemotherapy agent

Eligibility

Ages Eligible for Study:	18 Years and older
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

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

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00827203

Locations

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

No publications provided

Responsible Party:	Synta Pharmaceuticals ( David Hynds, Clinical Trials Manager )
Study ID Numbers:	4783-11
Study First Received:	January 20, 2009
Last Updated:	March 6, 2009
ClinicalTrials.gov Identifier:	NCT00827203 History of Changes
Health Authority:	United States: Food and Drug Administration

Keywords provided by Synta Pharmaceuticals, Corp.:

cancer
metastatic
Elesclomol Sodium
tumor
Advanced solid tumors that are metastatic and unresectable

ClinicalTrials.gov processed this record on September 11, 2009