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Last Updated: May 10, 2021

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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.
>Trial ID >Title >Status >Phase >Start Date >Summary

Clinical Trial Conditions for Trisenox

Condition Name

Condition Name for Trisenox
Intervention Trials
Lung Cancer 2
Leukemia 2
Multiple Myeloma 2
Acute Promyelocytic Leukemia 1
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Condition MeSH

Condition MeSH for Trisenox
Intervention Trials
Leukemia 6
Myelodysplastic Syndromes 3
Neoplasms, Plasma Cell 3
Multiple Myeloma 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
Puerto Rico 1
France 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
Active, not 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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