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Last Updated: October 12, 2024

CLINICAL TRIALS PROFILE FOR ORASONE


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505(b)(2) Clinical Trials for Orasone

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
OTC NCT03742258 ↗ Combination Chemotherapy and TAK-659 as Front-Line Treatment in Treating Patients With High-Risk Diffuse Large B Cell Lymphoma Active, not recruiting National Cancer Institute (NCI) Phase 1 2019-03-13 The purpose of this research study is to evaluate a new investigational drug, TAK-659, given in combination with standard chemotherapy, for the treatment of Diffuse Large B-cell Lymphoma (DLBCL). ?Investigational? means that TAK-659 has not been approved by the United States Food and Drug Administration (FDA) for use as a prescription or over-the-counter medication to treat a certain condition. The primary purpose of this study is to find the appropriate and safe dose of the study drug to be used in combination with standard chemotherapy for the treatment of your disease and to determine how well the drug works in treating the disease. Other objectives include measuring the amount of the study drug in the body at different times after taking the study drug. Participation in the study is expected to last for up to 3 years after receiving the last dose of the study drug. Patients will receive the study treatment for up to 18 weeks, as long as they are benefitting.
OTC NCT03742258 ↗ Combination Chemotherapy and TAK-659 as Front-Line Treatment in Treating Patients With High-Risk Diffuse Large B Cell Lymphoma Active, not recruiting Northwestern University Phase 1 2019-03-13 The purpose of this research study is to evaluate a new investigational drug, TAK-659, given in combination with standard chemotherapy, for the treatment of Diffuse Large B-cell Lymphoma (DLBCL). ?Investigational? means that TAK-659 has not been approved by the United States Food and Drug Administration (FDA) for use as a prescription or over-the-counter medication to treat a certain condition. The primary purpose of this study is to find the appropriate and safe dose of the study drug to be used in combination with standard chemotherapy for the treatment of your disease and to determine how well the drug works in treating the disease. Other objectives include measuring the amount of the study drug in the body at different times after taking the study drug. Participation in the study is expected to last for up to 3 years after receiving the last dose of the study drug. Patients will receive the study treatment for up to 18 weeks, as long as they are benefitting.
>Trial Type >Trial ID >Title >Status >Phase >Start Date >Summary

All Clinical Trials for Orasone

Trial ID Title Status Sponsor Phase Start Date Summary
NCT00003389 ↗ Combination Chemotherapy With or Without Radiation Therapy in Treating Patients With Hodgkin's Lymphoma Completed National Cancer Institute (NCI) Phase 3 1999-04-01 RATIONALE: Drugs used in chemotherapy use different ways to stop cancer cells from dividing so they stop growing or die. Radiation therapy uses high-energy x-rays to damage cancer cells. Combining more than one drug with radiation therapy may kill more cancer cells. It is not yet known which combination chemotherapy regimen is most effective in treating Hodgkin's lymphoma. PURPOSE: This randomized phase III trial is studying two different combination chemotherapy regimens and comparing how well they work, with or without radiation therapy, in treating patients with Hodgkin's lymphoma.
NCT00003389 ↗ Combination Chemotherapy With or Without Radiation Therapy in Treating Patients With Hodgkin's Lymphoma Completed Eastern Cooperative Oncology Group Phase 3 1999-04-01 RATIONALE: Drugs used in chemotherapy use different ways to stop cancer cells from dividing so they stop growing or die. Radiation therapy uses high-energy x-rays to damage cancer cells. Combining more than one drug with radiation therapy may kill more cancer cells. It is not yet known which combination chemotherapy regimen is most effective in treating Hodgkin's lymphoma. PURPOSE: This randomized phase III trial is studying two different combination chemotherapy regimens and comparing how well they work, with or without radiation therapy, in treating patients with Hodgkin's lymphoma.
NCT00004228 ↗ Combination Chemotx in Treating Children or Adolescents With Newly Diagnosed Stg III or Stg IV Lymphoblastic Lymphoma Completed National Cancer Institute (NCI) Phase 3 2000-06-01 RATIONALE: Drugs used in chemotherapy use different ways to stop cancer cells from dividing so they stop growing or die. It is not yet known which regimen of combination chemotherapy is most effective for lymphoblastic lymphoma. PURPOSE: This randomized phase III trial is studying different regimens of combination chemotherapy to compare how well they work in treating children or adolescents with newly diagnosed stage III or stage IV lymphoblastic lymphoma.
NCT00004228 ↗ Combination Chemotx in Treating Children or Adolescents With Newly Diagnosed Stg III or Stg IV Lymphoblastic Lymphoma Completed Children's Oncology Group Phase 3 2000-06-01 RATIONALE: Drugs used in chemotherapy use different ways to stop cancer cells from dividing so they stop growing or die. It is not yet known which regimen of combination chemotherapy is most effective for lymphoblastic lymphoma. PURPOSE: This randomized phase III trial is studying different regimens of combination chemotherapy to compare how well they work in treating children or adolescents with newly diagnosed stage III or stage IV lymphoblastic lymphoma.
NCT00025259 ↗ Chemotherapy With or Without Additional Chemotherapy and/or Radiation Therapy in Treating Children With Newly Diagnosed Hodgkin's Disease Completed National Cancer Institute (NCI) Phase 3 2002-09-01 This randomized phase III trial is studying different chemotherapy regimens given with or without radiation therapy to compare how well they work in treating children with newly diagnosed Hodgkin's disease. Drugs used in chemotherapy use different ways to stop cancer cells from dividing so they stop growing or die. Giving the drugs in different combinations may kill more cancer cells. Radiation therapy uses high-energy x-rays to damage cancer cells. It is not yet known if chemotherapy is more effective with or without additional chemotherapy and/or radiation therapy in treating Hodgkin's disease.
NCT00025259 ↗ Chemotherapy With or Without Additional Chemotherapy and/or Radiation Therapy in Treating Children With Newly Diagnosed Hodgkin's Disease Completed Children's Oncology Group Phase 3 2002-09-01 This randomized phase III trial is studying different chemotherapy regimens given with or without radiation therapy to compare how well they work in treating children with newly diagnosed Hodgkin's disease. Drugs used in chemotherapy use different ways to stop cancer cells from dividing so they stop growing or die. Giving the drugs in different combinations may kill more cancer cells. Radiation therapy uses high-energy x-rays to damage cancer cells. It is not yet known if chemotherapy is more effective with or without additional chemotherapy and/or radiation therapy in treating Hodgkin's disease.
>Trial ID >Title >Status >Phase >Start Date >Summary

Clinical Trial Conditions for Orasone

Condition Name

Condition Name for Orasone
Intervention Trials
Acute Lymphoblastic Leukemia 14
Untreated Adult Acute Lymphoblastic Leukemia 9
B Acute Lymphoblastic Leukemia 9
Leukemia 9
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Condition MeSH

Condition MeSH for Orasone
Intervention Trials
Lymphoma 44
Precursor Cell Lymphoblastic Leukemia-Lymphoma 33
Leukemia 33
Leukemia, Lymphoid 32
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Clinical Trial Locations for Orasone

Trials by Country

Trials by Country for Orasone
Location Trials
Canada 98
Australia 36
New Zealand 14
Puerto Rico 8
Switzerland 5
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Trials by US State

Trials by US State for Orasone
Location Trials
Texas 55
California 45
Illinois 42
Washington 40
New York 39
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Clinical Trial Progress for Orasone

Clinical Trial Phase

Clinical Trial Phase for Orasone
Clinical Trial Phase Trials
Phase 4 4
Phase 3 21
Phase 2/Phase 3 3
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Clinical Trial Status

Clinical Trial Status for Orasone
Clinical Trial Phase Trials
Recruiting 36
Active, not recruiting 27
Completed 22
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Clinical Trial Sponsors for Orasone

Sponsor Name

Sponsor Name for Orasone
Sponsor Trials
National Cancer Institute (NCI) 83
M.D. Anderson Cancer Center 24
Children's Oncology Group 9
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Sponsor Type

Sponsor Type for Orasone
Sponsor Trials
Other 105
NIH 86
Industry 45
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