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

NCT ID: NCT00827203

Last Updated: 2009-03-09

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

SUSPENDED

Clinical Phase

PHASE1

Total Enrollment

30 participants

Study Classification

INTERVENTIONAL

Study Start Date

2009-01-31

Study Completion Date

2011-01-31

Brief Summary

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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.

Detailed Description

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Conditions

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Metastatic Solid Tumors

Study Design

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Allocation Method

NON_RANDOMIZED

Intervention Model

SINGLE_GROUP

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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Cohort

Group Type EXPERIMENTAL

Elesclomol Sodium

Intervention Type DRUG

Chemotherapy agent

Interventions

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Elesclomol Sodium

Chemotherapy agent

Intervention Type DRUG

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Synta Pharmaceuticals Corp.

INDUSTRY

Sponsor Role lead

Responsible Party

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Synta Pharmaceuticals

Locations

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Mayo Clinic

Rochester, Maryland, United States

Site Status

University of Texas Health Science Center, Cancer Therapy & Research Center, Institute for Drug Development

San Antonio, Texas, United States

Site Status

University of Wisconsin Paul P. Carbone Comprehensive Cancer Center

Madison, Wisconsin, United States

Site Status

Countries

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United States

Other Identifiers

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4783-11

Identifier Type: -

Identifier Source: org_study_id

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