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Clinical Trial DRUG P3-STS-01

Title
A Multicenter, Randomized, Open-Label Phase 3 Study to Investigate the Efficacy and Safety of Aldoxorubicin Compared to Investigator’s Choice in Subjects with Metastatic, Locally Advanced, or Unresectable Soft Tissue Sarcomas Who Either Relapsed or Were Refractory to Prior Non-Adjuvant Chemotherapy
Principal Investigator
Mark Agulnik
Details
  • Status: Accepting New Patients
  • Study Type: Therapeutic, Treatment
  • Protocol No:.DRUG P3-STS-01
Purpose
The purpose of this study is to see if aldoxorubicin (the study drug) will slow cancer growth and also to evaluate the side effects of the treatment. Aldoxorubicin is a pro-drug of an approved chemotherapy drug called doxorubicin. Pro-drugs are inactive forms of a drug that only become active once inside the body.
Overview
This is a study of an investigational drug called aldoxorubicin. Investigational products have not received approval from regulatory authorities such as the United States Food and Drug Administration (FDA), which means they are still being studied to understand how safe they are and whether or not they are effective. The active part of aldoxorubicin is doxorubicin, a very powerful anti-tumor drug that is one of the most active anticancer drugs developed to date. It is used in the treatment of blood cancers and solid tumors such as breast and ovarian cancer. However, doxorubicin’s usefulness is limited by toxic dose-related side effects.
Eligibility
Some of the eligibility criteria include:
  • Participants must have high-grade sarcoma that is locally advanced and/or metastatic (it has spread beyond the original tumor) and cannot be removed with surgery.
  • Participants must be 15 or older.
  • Participants must have disease that has either returned or not responded to one or more prior treatment regimens.
Note: This is only a partial list of eligibility criteria. Please contact the Lurie Cancer Center for complete screening information if you are interested in this clinical trial.
Description of Treatment
Participants is this study will be randomized to receive either aldoxorubicin or the study doctor’s choice of treatment. Those selected to receive aldoxorubicin will receive the drug IV (through a vein) once every 3 weeks (21 days) until the tumor progresses. This 3 week (21 day) period is called a cycle. Those selected to receive the standard treatment of the doctor’s choice will have cycles that usually last up to 28 days. The doctor will discuss this choice with each participant in greater detail, including the length of a cycle.
Contact
Sara Duffey
Clinical Research and Education Specialist
Robert H. Lurie Comprehensive Cancer Center
312.695.1102
cancertrials@northwestern.edu

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last updated: 24-Oct-14 06:17 AM

 

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