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Last Updated: January 18, 2020

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CLINICAL TRIALS PROFILE FOR MITOMYCIN

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505(b)(2) Clinical Trials for Mitomycin

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 NCT00974818 Mitomycin C Versus Bacillus Calmette-Guerin in the Intravesical Treatment of Non-Muscle-Invasive Bladder Cancer Patients Terminated New York Presbyterian Hospital Phase 3 2009-09-01 The purpose of this study is to compare the bladder cancer treatments, Mitomycin C (MMC) and Bacillus Calmette Guerin (BCG), to find out which is better. In this study, the patient will get either the Mitomycin C (MMC) or the Bacillus Calmette Guerin (BCG). They will not get both. The patient had a Transurethral Resection (TUR) or an in office cystoscopy to make the diagnosis of bladder cancer. A biopsy was done and removed any tumors the doctor saw. Even after the doctor removes the tumors, the cancer can return. In this case, the doctor will put medicine into the bladder to destroy cancer cell. This is called intravesical therapy. The two most commonly used drugs for this purpose are MMC and BCG. Both drugs have been studied for many years. They both show good results when compared to other treatments. They have not been studied using the schedule that will be used in the study. The doctor does not know if these two drugs are equally effective in treating the cancer and preventing recurrence. BCG has been studied more often than MMC. The studies have shown that a long schedule of BCG is better than a short schedule of MMC. They have also shown that the side effects of BCG are more intense than with MMC. A recent study showed that a new dose of MMC is better than the old standard dose. Since the side effects of MMC occur less often, it is important to learn whether the two drugs are equally effective. That could help us decide between the treatments. In this study, the doctor will compare MMC and BCG when given for the same amount of time. The doctor hopes the study will tell us which drug is more effective in preventing the return of the cancer.
New Dosage NCT00974818 Mitomycin C Versus Bacillus Calmette-Guerin in the Intravesical Treatment of Non-Muscle-Invasive Bladder Cancer Patients Terminated Weill Medical College of Cornell University Phase 3 2009-09-01 The purpose of this study is to compare the bladder cancer treatments, Mitomycin C (MMC) and Bacillus Calmette Guerin (BCG), to find out which is better. In this study, the patient will get either the Mitomycin C (MMC) or the Bacillus Calmette Guerin (BCG). They will not get both. The patient had a Transurethral Resection (TUR) or an in office cystoscopy to make the diagnosis of bladder cancer. A biopsy was done and removed any tumors the doctor saw. Even after the doctor removes the tumors, the cancer can return. In this case, the doctor will put medicine into the bladder to destroy cancer cell. This is called intravesical therapy. The two most commonly used drugs for this purpose are MMC and BCG. Both drugs have been studied for many years. They both show good results when compared to other treatments. They have not been studied using the schedule that will be used in the study. The doctor does not know if these two drugs are equally effective in treating the cancer and preventing recurrence. BCG has been studied more often than MMC. The studies have shown that a long schedule of BCG is better than a short schedule of MMC. They have also shown that the side effects of BCG are more intense than with MMC. A recent study showed that a new dose of MMC is better than the old standard dose. Since the side effects of MMC occur less often, it is important to learn whether the two drugs are equally effective. That could help us decide between the treatments. In this study, the doctor will compare MMC and BCG when given for the same amount of time. The doctor hopes the study will tell us which drug is more effective in preventing the return of the cancer.
New Dosage NCT00974818 Mitomycin C Versus Bacillus Calmette-Guerin in the Intravesical Treatment of Non-Muscle-Invasive Bladder Cancer Patients Terminated Memorial Sloan Kettering Cancer Center Phase 3 2009-09-01 The purpose of this study is to compare the bladder cancer treatments, Mitomycin C (MMC) and Bacillus Calmette Guerin (BCG), to find out which is better. In this study, the patient will get either the Mitomycin C (MMC) or the Bacillus Calmette Guerin (BCG). They will not get both. The patient had a Transurethral Resection (TUR) or an in office cystoscopy to make the diagnosis of bladder cancer. A biopsy was done and removed any tumors the doctor saw. Even after the doctor removes the tumors, the cancer can return. In this case, the doctor will put medicine into the bladder to destroy cancer cell. This is called intravesical therapy. The two most commonly used drugs for this purpose are MMC and BCG. Both drugs have been studied for many years. They both show good results when compared to other treatments. They have not been studied using the schedule that will be used in the study. The doctor does not know if these two drugs are equally effective in treating the cancer and preventing recurrence. BCG has been studied more often than MMC. The studies have shown that a long schedule of BCG is better than a short schedule of MMC. They have also shown that the side effects of BCG are more intense than with MMC. A recent study showed that a new dose of MMC is better than the old standard dose. Since the side effects of MMC occur less often, it is important to learn whether the two drugs are equally effective. That could help us decide between the treatments. In this study, the doctor will compare MMC and BCG when given for the same amount of time. The doctor hopes the study will tell us which drug is more effective in preventing the return of the cancer.
New Formulation NCT03268499 TACE Emulsion Versus Suspension Recruiting Chinese University of Hong Kong Phase 2 2016-09-01 The aim of the study was to evaluate the safety and efficacy of using the new formulation (Lipiodol-cisplatin suspension) for TACE in the treatment of HCC as compared to the conventional formulation (Lipiodol-cisplatin emulsion). This is a prospective, parallel-group, open-label randomized, phase II study that is conducted in accordance to the Declaration of Helsinki and international standards of Good Clinical Practice, and approved by the institutional review board. Eligible patients were randomized into either a treatment arm of Lipiodol-cisplatin suspension or a control arm of Lipiodol-cisplatin emulsion with a 1:1 ratio.
>Trial Type >Trial ID >Title >Status >Phase >Start Date >Summary

All Clinical Trials for Mitomycin

Trial ID Title Status Sponsor Phase Start Date Summary
NCT00002490 Radiation Therapy, Chemotherapy, or Observation in Treating Patients With Bladder Cancer Completed Medical Research Council Phase 3 1991-09-01 RATIONALE: Radiation therapy uses high-energy x-rays to damage tumor cells. Drugs used in chemotherapy use different ways to stop tumor cells from dividing so they stop growing or die. Combining chemotherapy with radiation therapy may kill more tumor cells. It is not known whether receiving either radiation therapy, chemotherapy, or observation is more effective for cancer of the bladder. PURPOSE: Randomized phase III trial to compare the effectiveness of radiation therapy, chemotherapy, or observation following tumor surgery in treating patients who have bladder cancer.
NCT00002507 Radiation Therapy and Chemotherapy in Treating Patients With Head and Neck Cancer Completed Yale University Phase 3 1992-11-01 RATIONALE: Radiation therapy uses high-energy x-rays to damage tumor cells. Drugs used in chemotherapy use different ways to stop tumor cells from dividing so they stop growing or die. It is not yet known whether combining mitomycin or porfiromycin with radiation therapy is more effective in treating patients with head and neck cancer. PURPOSE: Randomized phase III trial to compare the effectiveness of radiation therapy plus either mitomycin or porfiromycin in treating patients with head and neck cancer.
NCT00002993 Combination Chemotherapy in Treating Patients With Recurrent or Advanced Cancer of the Uterus Terminated National Cancer Institute (NCI) Phase 2 1997-08-01 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 II trial to study the effectiveness of combination chemotherapy with mitomycin, doxorubicin, and cisplatin in treating patients with recurrent or advanced cancer of the uterus.
NCT00002993 Combination Chemotherapy in Treating Patients With Recurrent or Advanced Cancer of the Uterus Terminated Gynecologic Oncology Group Phase 2 1997-08-01 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 II trial to study the effectiveness of combination chemotherapy with mitomycin, doxorubicin, and cisplatin in treating patients with recurrent or advanced cancer of the uterus.
NCT00003003 Mitomycin and Mitoxantrone in Treating Patients With Acute Myelogenous Leukemia Completed National Cancer Institute (NCI) Phase 1 1996-09-01 RATIONALE: Drugs used in chemotherapy use different ways to stop cancer cells from dividing so they stop growing or die. Some cancers become resistant to chemotherapy drugs. Combining mitomycin with a chemotherapy drug may reduce resistance to the drug and allow the cancer cells to be killed. PURPOSE: Phase I trial to study the effectiveness of mitomycin and mitoxantrone in treating patients with acute myelogenous leukemia and to determine whether mitomycin can reduce the cancer's resistance to chemotherapy.
>Trial ID >Title >Status >Phase >Start Date >Summary

Clinical Trial Conditions for Mitomycin

Condition Name

Condition Name for Mitomycin
Intervention Trials
Bladder Cancer 22
Glaucoma 18
Colorectal Cancer 9
Gastric Cancer 7
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Condition MeSH

Condition MeSH for Mitomycin
Intervention Trials
Urinary Bladder Neoplasms 40
Carcinoma 36
Glaucoma 22
Anus Neoplasms 16
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Clinical Trial Locations for Mitomycin

Trials by Country

Trials by Country for Mitomycin
Location Trials
United States 315
United Kingdom 48
Italy 12
Korea, Republic of 11
Germany 10
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Trials by US State

Trials by US State for Mitomycin
Location Trials
Texas 19
California 18
Pennsylvania 17
New York 16
Maryland 16
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Clinical Trial Progress for Mitomycin

Clinical Trial Phase

Clinical Trial Phase for Mitomycin
Clinical Trial Phase Trials
Phase 4 16
Phase 3 48
Phase 2/Phase 3 12
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Clinical Trial Status

Clinical Trial Status for Mitomycin
Clinical Trial Phase Trials
Completed 67
Recruiting 44
Unknown status 32
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Clinical Trial Sponsors for Mitomycin

Sponsor Name

Sponsor Name for Mitomycin
Sponsor Trials
National Cancer Institute (NCI) 32
Medical Research Council 5
European Organisation for Research and Treatment of Cancer - EORTC 5
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Sponsor Type

Sponsor Type for Mitomycin
Sponsor Trials
Other 230
Industry 40
NIH 32
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