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Last Updated: July 16, 2020

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CLINICAL TRIALS PROFILE FOR TEMODAR

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505(b)(2) Clinical Trials for Temodar

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 Combination NCT01051596 A Study of ABT-888 in Combination With Temozolomide for Colorectal Cancer Completed Abbott Phase 2 2009-09-01 People with colorectal cancer that cannot be cured by surgery are being asked to participate in this study. The purpose of this study is to test the efficacy (effectiveness) of a new combination of drugs, ABT-888 and temozolomide for patients with colorectal cancer. Temozolomide acts by damaging deoxyribonucleic acid (DNA) in rapidly dividing cells, in other words, cancer cells. ABT-888 inhibits an enzyme called "PARP" which helps to fix damaged DNA. By inhibiting this enzyme, ABT-888 prevents cancer cells from repairing the damage caused by the temozolomide, and will hopefully increase the killing of cancer cells, and decrease the tumors in the body. ABT-888 is an investigational or experimental anti-cancer agent that has not yet been approved by the Food and Drug Administration (FDA) for use in colorectal cancer. This study will help find out what effects (good and bad) the combination of drugs, temozolomide and ABT-888 has on colorectal cancer. This research is being done because it is not known if ABT-888 will increase the effectiveness of temozolomide for colorectal cancer.
New Combination NCT01051596 A Study of ABT-888 in Combination With Temozolomide for Colorectal Cancer Completed Georgetown University Phase 2 2009-09-01 People with colorectal cancer that cannot be cured by surgery are being asked to participate in this study. The purpose of this study is to test the efficacy (effectiveness) of a new combination of drugs, ABT-888 and temozolomide for patients with colorectal cancer. Temozolomide acts by damaging deoxyribonucleic acid (DNA) in rapidly dividing cells, in other words, cancer cells. ABT-888 inhibits an enzyme called "PARP" which helps to fix damaged DNA. By inhibiting this enzyme, ABT-888 prevents cancer cells from repairing the damage caused by the temozolomide, and will hopefully increase the killing of cancer cells, and decrease the tumors in the body. ABT-888 is an investigational or experimental anti-cancer agent that has not yet been approved by the Food and Drug Administration (FDA) for use in colorectal cancer. This study will help find out what effects (good and bad) the combination of drugs, temozolomide and ABT-888 has on colorectal cancer. This research is being done because it is not known if ABT-888 will increase the effectiveness of temozolomide for colorectal cancer.
>Trial Type >Trial ID >Title >Status >Phase >Start Date >Summary

All Clinical Trials for Temodar

Trial ID Title Status Sponsor Phase Start Date Summary
NCT00005637 Combination Chemotherapy Following Radiation Therapy in Treating Patients With Malignant Glioma Completed National Cancer Institute (NCI) Phase 1 1999-12-01 RATIONALE: Drugs used in chemotherapy use different ways to stop tumor cells from dividing so they stop growing or die. Combining more than one chemotherapy drug may kill more tumor cells. PURPOSE: Phase I trial to study the effectiveness of combination chemotherapy following radiation therapy in treating patients who have malignant glioma.
NCT00005637 Combination Chemotherapy Following Radiation Therapy in Treating Patients With Malignant Glioma Completed Memorial Sloan Kettering Cancer Center Phase 1 1999-12-01 RATIONALE: Drugs used in chemotherapy use different ways to stop tumor cells from dividing so they stop growing or die. Combining more than one chemotherapy drug may kill more tumor cells. PURPOSE: Phase I trial to study the effectiveness of combination chemotherapy following radiation therapy in treating patients who have malignant glioma.
NCT00005951 Irinotecan Plus Temozolomide in Treating Patients With Recurrent Primary Malignant Glioma Completed National Cancer Institute (NCI) Phase 1 2000-08-01 RATIONALE: Drugs used in chemotherapy use different ways to stop tumor cells from dividing so they stop growing or die. Combining more than one drug may kill more tumor cells. PURPOSE: Phase I trial to study the effectiveness of irinotecan plus temozolomide in treating patients who have recurrent primary malignant glioma.
NCT00005951 Irinotecan Plus Temozolomide in Treating Patients With Recurrent Primary Malignant Glioma Completed Duke University Phase 1 2000-08-01 RATIONALE: Drugs used in chemotherapy use different ways to stop tumor cells from dividing so they stop growing or die. Combining more than one drug may kill more tumor cells. PURPOSE: Phase I trial to study the effectiveness of irinotecan plus temozolomide in treating patients who have recurrent primary malignant glioma.
NCT00005952 Temozolomide Plus Peripheral Stem Cell Transplantation in Treating Children With Newly Diagnosed Malignant Glioma or Recurrent CNS or Other Solid Tumors Completed National Cancer Institute (NCI) Phase 1/Phase 2 2000-08-01 RATIONALE: Drugs used in chemotherapy use different ways to stop tumor cells from dividing so they stop growing or die. Combining chemotherapy with peripheral stem cell transplantation may allow the doctor to give higher doses of chemotherapy drugs and kill more tumor cells. PURPOSE: This phase I/II trial is studying the side effects and best dose of temozolomide when given with peripheral stem cell transplantation and to see how well they work in treating children with newly diagnosed malignant glioma or recurrent CNS tumors or other solid tumors.
>Trial ID >Title >Status >Phase >Start Date >Summary

Clinical Trial Conditions for Temodar

Condition Name

Condition Name for Temodar
Intervention Trials
Glioblastoma 41
Gliosarcoma 22
Glioblastoma Multiforme 21
Anaplastic Astrocytoma 9
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Condition MeSH

Condition MeSH for Temodar
Intervention Trials
Glioblastoma 67
Glioma 36
Gliosarcoma 23
Astrocytoma 14
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Clinical Trial Locations for Temodar

Trials by Country

Trials by Country for Temodar
Location Trials
United States 248
Canada 7
Germany 7
Australia 6
United Kingdom 3
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Trials by US State

Trials by US State for Temodar
Location Trials
North Carolina 26
Texas 23
California 21
Massachusetts 15
New York 14
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Clinical Trial Progress for Temodar

Clinical Trial Phase

Clinical Trial Phase for Temodar
Clinical Trial Phase Trials
Phase 3 4
Phase 2/Phase 3 3
Phase 2 56
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Clinical Trial Status

Clinical Trial Status for Temodar
Clinical Trial Phase Trials
Completed 41
Not yet recruiting 38
Recruiting 20
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Clinical Trial Sponsors for Temodar

Sponsor Name

Sponsor Name for Temodar
Sponsor Trials
National Cancer Institute (NCI) 33
M.D. Anderson Cancer Center 14
Duke University 14
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Sponsor Type

Sponsor Type for Temodar
Sponsor Trials
Other 137
Industry 71
NIH 35
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Serving leading biopharmaceutical companies globally:

Colorcon
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Medtronic
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Harvard Business School
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