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Dose-Escalation Study of TH-302 in Combination With Doxorubicin to Treat Patients With Advanced Soft Tissue Sarcoma

Basic Trial Information
Trial Description
     Summary
     Further Trial Information
     Eligibility Criteria
Trial Contact Information

Basic Trial Information

Phase
Type
Status
Age
Sponsor
Protocol IDs

Phase II, Phase I

Biomarker/Laboratory analysis, Treatment

Active

18 and over

Pharmaceutical / Industry

TH-CR-403
NCT00742963

Trial Description

Summary

The purpose of this study is to determine whether TH-302 in combination with Doxorubicin is safe and effective in the treatment of Advanced Soft Tissue Sarcoma.

Further Study Information

A broad range of tumors have been shown to contain significant numbers of hypoxic cells and hypoxia has been shown to be associated with a poor prognosis and an increase in resistance to chemotherapy and radiotherapy (Brizel 1997, Vaupel 2007, Shannon 2003).

It is likely that an agent that could effectively target hypoxic regions in tumors would improve efficacy when combined with standard chemotherapy or radiotherapy. TH-302 is activated at lower oxygen concentrations than other bioreductive prodrugs (Duan 2008) and tirapazamine, a hypoxic cytotoxin that has been extensively studied in both preclinical and clinical studies. This should result in an improved therapeutic ratio (tumor vs normal tissue toxicity) as compared with other bioreductive agents. Because TH-302 is expected to be minimally toxic to aerobic cancer cells, optimal efficacy would be expected when TH-302 is combined with treatments that are most effective under aerobic conditions such as radiotherapy and cytotoxic chemotherapy. Preclinical data have shown at least additive efficacy when TH-302 is combined with chemotherapy. In order to minimize the risk of additive toxicity, TH-302 is not being evaluated in combination with alkylating agents. The study will enroll subjects with advanced soft tissue sarcoma. These tumors have evidence supporting the presence of hypoxia based on pO2 histography, F-MISO and gene expression profiling (Vaupel 2007, Francis 2007, Rajendran 2003).

Eligibility Criteria

Inclusion Criteria -

All Subjects:

At least 18 years of age

Ability to understand the purposes and risks of the study and has signed a written informed consent form approved by the investigator's IRB/Ethics Committee

Pathologically confirmed diagnosis of soft tissue sarcoma of the following subtypes:

Trial Contact Information

Trial Lead Organizations/Sponsors

Threshold Pharmaceuticals

Sant P. Chawla

Principal Investigator

Clarence Eng, MPH		Ph: 650-474-8222
		Email: ceng@thresholdpharm.com

Gustavo Lorente, MS		Ph: 650-474-8228
		Email: glorente@thresholdpharm.com

Trial Sites

U.S.A.

California

Santa Monica

Sarcoma Oncology Center

Sant P. Chawla Ph: 310-552-9999

Email: santchawla@aol.com

Victoria Chua Ph: 310-552-9999

Email: vikychua@aol.com

Sant P. Chawla Principal Investigator

Link to the current ClinicalTrials.gov record.
NLM Identifer NCT00742963
Information obtained from ClinicalTrials.gov on August 28, 2008

Note: Information about this trial is from the ClinicalTrials.gov database. The versions designated for health professionals and patients contain the same text. Minor changes may be made to the ClinicalTrials.gov record to standardize the names of study sponsors, sites, and contacts. Cancer.gov only lists sites that are recruiting patients for active trials, whereas ClinicalTrials.gov lists all sites for all trials. Questions and comments regarding the presented information should be directed to ClinicalTrials.gov.