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Last Updated: July 16, 2020

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CLINICAL TRIALS PROFILE FOR TRISENOX

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505(b)(2) Clinical Trials for Trisenox

This table shows clinical trials for potential 505(b)(2) applications. See the next table for all clinical trials
Trial Type Trial ID Title Status Sponsor Phase Start Date Summary
New Dosage NCT00225992 Phase II Research Study of Arsenic Trioxide (Trisenox) in Patients With Myelodysplastic Syndrome (MDS) Terminated Oncology Specialties, Alabama Phase 2 2004-02-01 In this phase II study besides evaluating for safety, the primary efficacy parameter is to evaluate the incidence of patients who have had a response to Trisenox by evidence of increased blood counts (red, white, or platelets) and/or by decrease or transfusion dependency. The secondary efficacy parameter is the assessment of the tolerability of the new dosing schedule. Arsenic trioxide will be administered intravenously over 1 to 2 hours with a loading dose of 0.30mg/kg for days 1-5 of the first week and then twice weekly for 27 weeks for a total of 28 weeks.
>Trial Type >Trial ID >Title >Status >Phase >Start Date >Summary

All Clinical Trials for Trisenox

Trial ID Title Status Sponsor Phase Start Date Summary
NCT00053248 Arsenic Trioxide and Imatinib Mesylate in Treating Patients With Chronic Myelogenous Leukemia Completed National Cancer Institute (NCI) Phase 1/Phase 2 2002-10-01 RATIONALE: Drugs used in chemotherapy use different ways to stop cancer cells from dividing so they stop growing or die. Imatinib mesylate may stop the growth of cancer cells by blocking the enzymes necessary for cancer cell growth. Combining chemotherapy with imatinib mesylate may kill more cancer cells. PURPOSE: Phase I/II trial to study the effectiveness of combining arsenic trioxide with imatinib mesylate in treating patients who have chronic phase chronic myelogenous leukemia.
NCT00053248 Arsenic Trioxide and Imatinib Mesylate in Treating Patients With Chronic Myelogenous Leukemia Completed OHSU Knight Cancer Institute Phase 1/Phase 2 2002-10-01 RATIONALE: Drugs used in chemotherapy use different ways to stop cancer cells from dividing so they stop growing or die. Imatinib mesylate may stop the growth of cancer cells by blocking the enzymes necessary for cancer cell growth. Combining chemotherapy with imatinib mesylate may kill more cancer cells. PURPOSE: Phase I/II trial to study the effectiveness of combining arsenic trioxide with imatinib mesylate in treating patients who have chronic phase chronic myelogenous leukemia.
NCT00075413 Arsenic Trioxide in Treating Women With Locally Advanced or Metastatic Breast Cancer Withdrawn The University of Texas Medical Branch, Galveston Phase 2 2002-11-01 RATIONALE: Drugs used in chemotherapy, such as arsenic trioxide, use different ways to stop tumor cells from dividing so they stop growing or die. PURPOSE: This phase II trial is studying how well arsenic trioxide works in treating women with locally advanced or metastatic breast cancer.
NCT00075426 Arsenic Trioxide in Treating Patients With Locally Advanced or Metastatic Non-Small Cell Lung Cancer Completed The University of Texas Medical Branch, Galveston Phase 2 2002-11-01 RATIONALE: Drugs used in chemotherapy, such as arsenic trioxide, use different ways to stop tumor cells from dividing so they stop growing or die. PURPOSE: This phase II trial is studying how well arsenic trioxide works in treating patients with locally advanced or metastatic non-small cell lung cancer.
NCT00128596 Arsenic Trioxide in Treating Patients With Metastatic Liver Cancer That Cannot Be Removed by Surgery Completed University of Pittsburgh Phase 2 2004-06-01 RATIONALE: Drugs used in chemotherapy, such as arsenic trioxide, work in different ways to stop the growth of tumor cells, either by killing the cells or by stopping them from dividing. PURPOSE: This phase II trial is studying how well arsenic trioxide works in treating patients with metastatic liver cancer that cannot be removed by surgery.
NCT00184054 Trial of Arsenic Trioxide With Ascorbic Acid in the Treatment of Adult Non-Acute Promyelocytic Leukemia (APL) Acute Myelogenous Leukemia Terminated University of Southern California Phase 2 2002-04-01 This clinical research study is for patients with acute myelogenous leukemia (in short AML) that did not respond to previous treatment or unable to receive chemotherapy. Arsenic has been used as a drug for many centuries. While arsenic containing drugs were used in the past for cancer treatments, the major use of arsenic in western countries has been for the treatment of uncommon tropical illnesses, such as sleeping sickness. Recently, some new information suggests that arsenic in a form called arsenic trioxide may also be useful to treat some cancers of the blood, such as leukemia, lymphoma and myeloma. Studies from China and the USA showed that patients with a type of blood cancer called acute promyelocytic leukemia, whose disease failed to respond to other treatments, responded very well to arsenic trioxide. Studies done in laboratories in the United States have shown that arsenic can kill AML cells growing in culture dishes. Ascorbic acid (vitamin C), a natural supplement in our diet, has long been involved with cancer prevention. Laboratory tests have shown that although arsenic trioxide by itself can kill AML cells in the test tube, when vitamin C is added to arsenic trioxide in a test tube, the death of the leukemia cells increases significantly. The purpose of this study is to find out if the combination of arsenic trioxide (Trisenox) and ascorbic acid is effective in the treatment of patients who have AML. The second purpose is to study how the two drugs affect cells in the laboratory. Samples from the blood and bone marrow (the part of the body that makes blood cells) will be collected, at specific times during treatment, in order to study them in the laboratory. By studying blood and marrow cells, researchers hope to learn the mechanisms by which the drugs work.
NCT00193518 Arsenic Trioxide in Relapsed/Refractory Chronic Lymphocytic Leukemia/Small Lymphocytic Lymphoma Completed CTI BioPharma Phase 2 2004-04-01 Additional active agents are needed to further improve the treatment of patients with CLL/SLL. Increasing information exists regarding the activity of arsenic trioxide in other hematologic malignancies. Since arsenic trioxide produces mild to moderate myelosuppression and is not as immunosuppressive as other available agents, it may be an additional treatment option for CLL/SLL. This study will evaluate the feasibility and toxicity of arsenic trioxide in patients with relapsed or refractory CLL/SLL
>Trial ID >Title >Status >Phase >Start Date >Summary

Clinical Trial Conditions for Trisenox

Condition Name

Condition Name for Trisenox
Intervention Trials
Multiple Myeloma 2
Lung Cancer 2
Leukemia 2
Myelodysplastic Syndrome 1
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Condition MeSH

Condition MeSH for Trisenox
Intervention Trials
Leukemia 6
Preleukemia 3
Myelodysplastic Syndromes 3
Neoplasms, Plasma Cell 3
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Clinical Trial Locations for Trisenox

Trials by Country

Trials by Country for Trisenox
Location Trials
United States 62
Canada 6
France 1
Puerto Rico 1
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Trials by US State

Trials by US State for Trisenox
Location Trials
Texas 6
California 4
Ohio 4
North Carolina 3
New York 3
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Clinical Trial Progress for Trisenox

Clinical Trial Phase

Clinical Trial Phase for Trisenox
Clinical Trial Phase Trials
Phase 3 1
Phase 2 14
Phase 1/Phase 2 2
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Clinical Trial Status

Clinical Trial Status for Trisenox
Clinical Trial Phase Trials
Completed 8
Terminated 6
Recruiting 2
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Clinical Trial Sponsors for Trisenox

Sponsor Name

Sponsor Name for Trisenox
Sponsor Trials
Cephalon 5
National Cancer Institute (NCI) 3
The University of Texas Medical Branch, Galveston 3
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Sponsor Type

Sponsor Type for Trisenox
Sponsor Trials
Other 24
Industry 8
NIH 4
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Serving leading biopharmaceutical companies globally:

Colorcon
Baxter
Dow
Medtronic
McKesson
AstraZeneca

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