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Last Updated: May 23, 2022

CLINICAL TRIALS PROFILE FOR FLUOROURACIL


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505(b)(2) Clinical Trials for Fluorouracil

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 NCT01489865 ↗ ABT-888 With Modified FOLFOX6 in Patients With Metastatic Pancreatic Cancer Unknown status Abbott Phase 1/Phase 2 2011-02-01 People are being asked to participate in this study who have metastatic pancreatic cancer (cancer that has spread to other parts of the body). The purpose of this study is to test the efficacy (effectiveness) of a new combination of drugs, ABT-888 and mFOLFOX-6 (modified 5-Fluorouracil and Oxaliplatin) for patients with metastatic pancreatic cancer. 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 mFOLFOX-6, and will hopefully increase the killing of cancer cells, thus decreasing the tumors in your body.
New Combination NCT01489865 ↗ ABT-888 With Modified FOLFOX6 in Patients With Metastatic Pancreatic Cancer Unknown status Georgetown University Phase 1/Phase 2 2011-02-01 People are being asked to participate in this study who have metastatic pancreatic cancer (cancer that has spread to other parts of the body). The purpose of this study is to test the efficacy (effectiveness) of a new combination of drugs, ABT-888 and mFOLFOX-6 (modified 5-Fluorouracil and Oxaliplatin) for patients with metastatic pancreatic cancer. 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 mFOLFOX-6, and will hopefully increase the killing of cancer cells, thus decreasing the tumors in your body.
New Combination NCT01522989 ↗ PD-0332991, 5-FU, and Oxaliplatin for Advanced Solid Tumor Malignancies Unknown status Pfizer Phase 1 2011-12-01 This study is for patients with advanced solid tumor malignancies (cancer that has spread to other parts of the body). The purpose of this study is to test the safety and effectiveness of a new combination of drugs, PD-0332991 and 5-Fluorouracil and Oxaliplatin for patients with advanced solid tumor malignancies . PD-0332991 stops cells from dividing by blocking an enzyme called cyclin-dependent kinase (CDK), which cancer cells need to grow and divide. By inhibiting this enzyme, PD-0332991 prevent cancer cells from growing and dividing, while the 5-Fluorouracil and Oxaliplatin damage the cells, hopefully increasing the killing of cancer cells, thus decreasing the tumors in the body. PD-0332991 is an investigational or experimental anti-cancer agent that has not yet been approved by the Food and Drug Administration for use in colorectal cancer. It is given as a pill which is taken once a day for one week followed by one week off. 5-Fluorouracil and Oxaliplatin are administered as an infusion into a vein once every 2 weeks and are approved for and used as chemotherapy for several cancers.
>Trial Type >Trial ID >Title >Status >Phase >Start Date >Summary

All Clinical Trials for Fluorouracil

Trial ID Title Status Sponsor Phase Start Date Summary
NCT00000122 ↗ Fluorouracil Filtering Surgery Study (FFSS) Completed National Eye Institute (NEI) Phase 3 1985-09-01 To determine whether postoperative subconjunctival injections of 5-fluorouracil (5-FU) increase the success rate of filtering surgery in patients at high risk for failure after standard glaucoma filtering surgery.
NCT00000758 ↗ A Phase III Randomized Trial of Topical Vaginal Fluorouracil (5-Fluorouracil, 5-FU) Maintenance Therapy Versus Observation After Standard Treatment for High-Grade Cervical Dysplasia in HIV-Infected Women Completed Hoffmann-La Roche Phase 3 1969-12-31 To determine the efficacy and safety of intravaginal fluorouracil administered as prophylaxis in HIV-infected women who have received standard ablative therapy (surgery) for high-grade cervical dysplasia (pre-cancer of the cervix; cervical intraepithelial neoplasia). To correlate time to recurrence of cervical dysplasia with T-cell function. Women with HIV infection are at greater risk for cervical dysplasia. Because of the likelihood that untreated or recurrent cervical dysplasia may progress to invasive cancer, there is an urgent need to develop appropriate therapies.
NCT00000758 ↗ A Phase III Randomized Trial of Topical Vaginal Fluorouracil (5-Fluorouracil, 5-FU) Maintenance Therapy Versus Observation After Standard Treatment for High-Grade Cervical Dysplasia in HIV-Infected Women Completed National Institute of Allergy and Infectious Diseases (NIAID) Phase 3 1969-12-31 To determine the efficacy and safety of intravaginal fluorouracil administered as prophylaxis in HIV-infected women who have received standard ablative therapy (surgery) for high-grade cervical dysplasia (pre-cancer of the cervix; cervical intraepithelial neoplasia). To correlate time to recurrence of cervical dysplasia with T-cell function. Women with HIV infection are at greater risk for cervical dysplasia. Because of the likelihood that untreated or recurrent cervical dysplasia may progress to invasive cancer, there is an urgent need to develop appropriate therapies.
>Trial ID >Title >Status >Phase >Start Date >Summary

Clinical Trial Conditions for Fluorouracil

Condition Name

Condition Name for Fluorouracil
Intervention Trials
Colorectal Cancer 276
Breast Cancer 122
Gastric Cancer 103
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Condition MeSH

Condition MeSH for Fluorouracil
Intervention Trials
Colorectal Neoplasms 487
Adenocarcinoma 246
Carcinoma 220
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Clinical Trial Locations for Fluorouracil

Trials by Country

Trials by Country for Fluorouracil
Location Trials
United States 5,643
China 479
Canada 371
Japan 336
Italy 320
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Trials by US State

Trials by US State for Fluorouracil
Location Trials
California 256
New York 250
Illinois 215
Texas 214
Florida 199
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Clinical Trial Progress for Fluorouracil

Clinical Trial Phase

Clinical Trial Phase for Fluorouracil
Clinical Trial Phase Trials
Phase 4 29
Phase 3 415
Phase 2/Phase 3 53
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Clinical Trial Status

Clinical Trial Status for Fluorouracil
Clinical Trial Phase Trials
Completed 843
Recruiting 243
Unknown status 238
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Clinical Trial Sponsors for Fluorouracil

Sponsor Name

Sponsor Name for Fluorouracil
Sponsor Trials
National Cancer Institute (NCI) 362
Sanofi 65
Sun Yat-sen University 53
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Sponsor Type

Sponsor Type for Fluorouracil
Sponsor Trials
Other 2105
Industry 705
NIH 371
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