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Last Updated: September 29, 2020

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CLINICAL TRIALS PROFILE FOR TEMOZOLOMIDE

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505(b)(2) Clinical Trials for TEMOZOLOMIDE

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 NCT00876993 Study of Irinotecan and Bevacizumab With Temozolomide in Refractory/Relapsed Central Nervous System (CNS) Tumors Completed V Foundation Phase 1 2008-09-01 Bevacizumab, irinotecan, and temozolomide are three agents shown to have promising activity in a variety of central nervous system tumors. No prospective studies have been published or are currently in progress within the major consortiums with this combination of drugs. Brain tumors are the second most common cause of cancer in pediatrics and the leading cause of cancer death in children. For children with High Grade Gliomas or with relapsed/refractory brain tumors, new agents in new combinations are needed. Historical data shows that newly diagnosed high grade gliomas 5 year progression free survival is 28-42%. Recurrent malignant gliomas median survival is 3-9 months. Recurrent medulloblastoma's 2 years survival is 9%. This study is a phase I study designed to provide an objective observation of toxicity and establish a maximum tolerated dose of this combination. In addition, this study will observe the response of children with relapsed or refractory central nervous system tumors.
New Combination NCT00876993 Study of Irinotecan and Bevacizumab With Temozolomide in Refractory/Relapsed Central Nervous System (CNS) Tumors Completed Johns Hopkins All Children's Hospital Phase 1 2008-09-01 Bevacizumab, irinotecan, and temozolomide are three agents shown to have promising activity in a variety of central nervous system tumors. No prospective studies have been published or are currently in progress within the major consortiums with this combination of drugs. Brain tumors are the second most common cause of cancer in pediatrics and the leading cause of cancer death in children. For children with High Grade Gliomas or with relapsed/refractory brain tumors, new agents in new combinations are needed. Historical data shows that newly diagnosed high grade gliomas 5 year progression free survival is 28-42%. Recurrent malignant gliomas median survival is 3-9 months. Recurrent medulloblastoma's 2 years survival is 9%. This study is a phase I study designed to provide an objective observation of toxicity and establish a maximum tolerated dose of this combination. In addition, this study will observe the response of children with relapsed or refractory central nervous system tumors.
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.
New Combination NCT01205828 ABT-888 and Temozolomide for Liver Cancer Terminated Abbott Phase 2 2010-08-01 This study is for people with liver cancer (also called hepatocellular carcinoma, or HCC in abbreviation). The purpose of this study is to test the efficacy (effectiveness) of a new combination of drugs, ABT-888 and temozolomide for patients with liver 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 liver cancer. This study will help find out what effects (good and bad) the combination of drugs, temozolomide and ABT-888, has on liver cancer. This research is being done because it is not known if ABT-888 will increase the effectiveness of temozolomide in liver cancer.
>Trial Type >Trial ID >Title >Status >Phase >Start Date >Summary

All Clinical Trials for TEMOZOLOMIDE

Trial ID Title Status Sponsor Phase Start Date Summary
NCT00003062 Temozolomide in Patients With Progressive or Recurrent Non-small Cell Lung Cancer Completed European Organisation for Research and Treatment of Cancer - EORTC Phase 2 1997-07-01 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 effect of temozolomide in patients with progressive or recurrent stage IV non-small cell lung cancer, with or without brain metastases, who have not been treated for metastatic disease with chemotherapy.
NCT00003176 Temozolomide and Carmustine in Treating Patients With Anaplastic Glioma Unknown status National Cancer Institute (NCI) Phase 2 1998-01-01 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 II trial to study the effectiveness of temozolomide and carmustine in treating patients with anaplastic glioma.
NCT00003176 Temozolomide and Carmustine in Treating Patients With Anaplastic Glioma Unknown status North American Brain Tumor Consortium Phase 2 1998-01-01 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 II trial to study the effectiveness of temozolomide and carmustine in treating patients with anaplastic glioma.
NCT00003273 Chemotherapy Followed by Peripheral Stem Cell Transplantation in Treating Children With Newly Diagnosed Brain Tumor Withdrawn New York University School of Medicine Phase 2 1997-11-01 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: Phase II trial to study the effectiveness of different regimens of combination chemotherapy followed by peripheral stem cell transplantation in treating children who have newly diagnosed brain tumor.
NCT00003304 Temozolomide in Treating Patients With Recurrent Oligodendroglial Tumors Completed European Organisation for Research and Treatment of Cancer - EORTC Phase 2 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 II trial to study the effectiveness of temozolomide in treating patients with recurrent oligodendroglial tumors following combination chemotherapy.
>Trial ID >Title >Status >Phase >Start Date >Summary

Clinical Trial Conditions for TEMOZOLOMIDE

Condition Name

Condition Name for TEMOZOLOMIDE
Intervention Trials
Glioblastoma 165
Glioblastoma Multiforme 110
Brain and Central Nervous System Tumors 89
Gliosarcoma 45
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Condition MeSH

Condition MeSH for TEMOZOLOMIDE
Intervention Trials
Glioblastoma 380
Glioma 172
Central Nervous System Neoplasms 110
Nervous System Neoplasms 108
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Clinical Trial Locations for TEMOZOLOMIDE

Trials by Country

Trials by Country for TEMOZOLOMIDE
Location Trials
Canada 224
United Kingdom 88
France 85
Spain 70
Germany 67
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Trials by US State

Trials by US State for TEMOZOLOMIDE
Location Trials
California 157
Texas 134
New York 130
North Carolina 124
Pennsylvania 120
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Clinical Trial Progress for TEMOZOLOMIDE

Clinical Trial Phase

Clinical Trial Phase for TEMOZOLOMIDE
Clinical Trial Phase Trials
Phase 4 3
Phase 3 59
Phase 2/Phase 3 14
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Clinical Trial Status

Clinical Trial Status for TEMOZOLOMIDE
Clinical Trial Phase Trials
Completed 280
Recruiting 177
Not yet recruiting 141
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Clinical Trial Sponsors for TEMOZOLOMIDE

Sponsor Name

Sponsor Name for TEMOZOLOMIDE
Sponsor Trials
National Cancer Institute (NCI) 207
Schering-Plough 36
M.D. Anderson Cancer Center 32
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Sponsor Type

Sponsor Type for TEMOZOLOMIDE
Sponsor Trials
Other 933
Industry 377
NIH 217
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