Clinical Trial DRUG P3-STS-01
- 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
- Status: CLOSED
- Study Type: Therapeutic, Treatment
- Protocol No:.DRUG P3-STS-01
- 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.
- 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.
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.
- 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.
- Sara Duffey
Clinical Research and Education Specialist
Robert H. Lurie Comprehensive Cancer Center
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- A Phase III Randomized Trial of Adding Vincristine-topotecan-cyclophosphamide to Standard Chemotherapy in Initial Treatment of Non-metastatic Ewing Sarcoma
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- A Phase 1 Study to Evaluate the Safety, Tolerability, and Efficacy of MEDI4736 in Combination with Tremelimumab or Tremelimumab Alone in Subjects with Recurrent or Metastatic Squamous Cell Carcinoma of the Head and Neck
- A Phase II, Multicenter Study of the EZH2 Inhibitor Tazemetostat in Adult Subjects with INI1-Negative Tumors or Relapsed/Refractory Synovial Sarcoma
- Phase 2 Efficacy and Safety Study of Intravenous GPX-150, an Anthracycline Analog, in Patients with Soft Tissue Sarcoma
- An Open-Label Study to Evaluate the Pharmacokinetics of Doxorubicin following the Concomitant Intravenous Administration of Olaratumab (IMC-3G3) to Patients with Advanced Soft Tissue Sarcoma
- Multicenter Phase II Study of Nivolumab in Previously Treated Patients with Recurrent and Metastatic Nasopharyngeal Carcinoma
- Multicenter, Open-Label Phase II Study of Daily Oral Regorafenib for Chemotherapy-Refractory, Metastatic and Locally Advanced Angiosarcoma
- A Phase II Study of Pazopanib with Oral Topotecan in Patients with Metastatic and Non-resectable Soft Tissue and Bone Sarcomas
- Phase II Study Evaluating the Role of Pazopanib in Angiosarcoma (OER-SAR-043)
- A Blanket Protocol to Study Oral Regorafenib in Patients with Refractory Liposarcoma, Osteogenic Sarcoma, and Ewing/Ewing–Like Sarcomas
- A Phase II Study of Pazopanib as Front-Line Therapy in Patients with Non-Resectable or Metastatic Soft Tissue Sarcomas Who Are Not Candidates for Chemotherapy
last updated: 28-May-16 12:57 AM
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