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Last Updated: November 27, 2022

CLINICAL TRIALS PROFILE FOR ARSENIC TRIOXIDE


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505(b)(2) Clinical Trials for Arsenic Trioxide

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 Arsenic Trioxide

Trial ID Title Status Sponsor Phase Start Date Summary
NCT00003395 ↗ Arsenic Trioxide in Treating Patients With Advanced Hematologic Cancer Completed National Cancer Institute (NCI) Phase 1 1998-04-01 RATIONALE: Drugs used in chemotherapy use different ways to stop tumor cells from dividing so they stop growing or die. PURPOSE: Phase I trial to study the effectiveness of arsenic trioxide in treating patients who have advanced hematologic cancer.
NCT00003395 ↗ Arsenic Trioxide in Treating Patients With Advanced Hematologic Cancer Completed Memorial Sloan Kettering Cancer Center Phase 1 1998-04-01 RATIONALE: Drugs used in chemotherapy use different ways to stop tumor cells from dividing so they stop growing or die. PURPOSE: Phase I trial to study the effectiveness of arsenic trioxide in treating patients who have advanced hematologic cancer.
NCT00003630 ↗ Arsenic Trioxide in Treating Patients With Advanced Solid Tumors Completed National Cancer Institute (NCI) Phase 1 1998-08-01 RATIONALE: Drugs used in chemotherapy use different ways to stop tumor cells from dividing so they stop growing or die. PURPOSE: Phase I trial to study the effectiveness of arsenic trioxide in treating patients who have advanced solid tumors.
NCT00003630 ↗ Arsenic Trioxide in Treating Patients With Advanced Solid Tumors Completed Memorial Sloan Kettering Cancer Center Phase 1 1998-08-01 RATIONALE: Drugs used in chemotherapy use different ways to stop tumor cells from dividing so they stop growing or die. PURPOSE: Phase I trial to study the effectiveness of arsenic trioxide in treating patients who have advanced solid tumors.
NCT00003885 ↗ Arsenic Trioxide in Treating Patients With Recurrent or Refractory Acute Leukemia, Chronic Myeloide Leukemia, Myelodysplasia, Lymphoma, or Myeloma Unknown status Our Lady of Mercy Medical Center Phase 2 1997-11-01 RATIONALE: Drugs used in chemotherapy use different ways to stop cancer cells from dividing so they stop growing or die. PURPOSE: Phase II trial to study the effectiveness of arsenic trioxide in treating patients who have recurrent or refractory acute leukemia, chronic myeloid leukemia, myelodysplasia, lymphoma, or myeloma.
NCT00003934 ↗ Tretinoin, Cytarabine, and Daunorubicin Hydrochloride With or Without Arsenic Trioxide Followed by Tretinoin With or Without Mercaptopurine and Methotrexate in Treating Patients With Acute Promyelocytic Leukemia Completed National Cancer Institute (NCI) Phase 3 1999-06-01 This randomized phase III trial is studying tretinoin and combination chemotherapy to see how well they work compared to tretinoin, combination chemotherapy, and arsenic trioxide in treating patients with acute promyelocytic leukemia that has not been treated previously. Drugs used in chemotherapy, such as daunorubicin, cytarabine, mercaptopurine, methotrexate, and arsenic trioxide, work in different ways to stop cancer cells from dividing so they stop growing or die. Tretinoin may help leukemia cells develop into normal white blood cells. It is not yet known which regimen is more effective for acute promyelocytic leukemia.
NCT00004149 ↗ Arsenic Trioxide in Treating Patients With Stage IV Prostate Cancer That Has Not Responded to Previous Hormone Therapy Completed National Cancer Institute (NCI) Phase 2 1999-09-01 RATIONALE: Drugs used in chemotherapy use different ways to stop tumor cells from dividing so they stop growing or die. PURPOSE: Phase II trial to study the effectiveness of arsenic trioxide in treating patients who have stage IV prostate cancer that has not responded to hormone therapy.
>Trial ID >Title >Status >Phase >Start Date >Summary

Clinical Trial Conditions for Arsenic Trioxide

Condition Name

Condition Name for Arsenic Trioxide
Intervention Trials
Leukemia 31
Acute Promyelocytic Leukemia 15
Myelodysplastic Syndromes 13
Multiple Myeloma and Plasma Cell Neoplasm 9
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Condition MeSH

Condition MeSH for Arsenic Trioxide
Intervention Trials
Leukemia 65
Leukemia, Promyelocytic, Acute 32
Leukemia, Myeloid 22
Preleukemia 20
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Clinical Trial Locations for Arsenic Trioxide

Trials by Country

Trials by Country for Arsenic Trioxide
Location Trials
United States 382
China 36
Canada 23
Italy 17
Spain 11
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Trials by US State

Trials by US State for Arsenic Trioxide
Location Trials
New York 31
California 26
Texas 23
Illinois 20
Florida 14
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Clinical Trial Progress for Arsenic Trioxide

Clinical Trial Phase

Clinical Trial Phase for Arsenic Trioxide
Clinical Trial Phase Trials
Phase 4 5
Phase 3 12
Phase 2/Phase 3 3
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Clinical Trial Status

Clinical Trial Status for Arsenic Trioxide
Clinical Trial Phase Trials
Completed 62
Terminated 26
Recruiting 20
[disabled in preview] 27
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Clinical Trial Sponsors for Arsenic Trioxide

Sponsor Name

Sponsor Name for Arsenic Trioxide
Sponsor Trials
National Cancer Institute (NCI) 52
Cephalon 13
Memorial Sloan Kettering Cancer Center 11
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Sponsor Type

Sponsor Type for Arsenic Trioxide
Sponsor Trials
Other 175
NIH 54
Industry 45
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