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Last Updated: October 24, 2020

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CLINICAL TRIALS PROFILE FOR CELECOXIB

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505(b)(2) Clinical Trials for Celecoxib

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 NCT00177853 Celecoxib, Irinotecan and Concurrent Radiotherapy in Preoperative Pancreatic Cancer Terminated Pharmacia and Upjohn Phase 1 2006-12-01 The purposes of this study are to examine the effects of a new combination of drugs, celecoxib (Celebrex®) and irinotecan (CPT-11), with standard radiation therapy on people before they undergo surgery; to determine what effects this combination has on pancreatic cancer; and to determine the highest dose of celecoxib and irinotecan that can be given safely without causing severe side effects. While not an endpoint, it is hoped that this combination will also shrink tumors enough for excision.
New Combination NCT00177853 Celecoxib, Irinotecan and Concurrent Radiotherapy in Preoperative Pancreatic Cancer Terminated University of Pittsburgh Phase 1 2006-12-01 The purposes of this study are to examine the effects of a new combination of drugs, celecoxib (Celebrex®) and irinotecan (CPT-11), with standard radiation therapy on people before they undergo surgery; to determine what effects this combination has on pancreatic cancer; and to determine the highest dose of celecoxib and irinotecan that can be given safely without causing severe side effects. While not an endpoint, it is hoped that this combination will also shrink tumors enough for excision.
New Combination NCT00230399 Combination Chemotherapy Treatments in Patients With Metastatic Colorectal Cancer Completed University of Michigan Cancer Center Phase 2 2003-06-01 This study will examine a new combination of drugs: celecoxib, capecitabine and irinotecan, for the treatment of metastatic colorectal cancer. Capecitabine and irinotecan, individually, are approved by the Food and Drug Administration (FDA) for use in colorectal cancer. The combination of these two drugs is experimental (not approved by the FDA as standard treatment), but is a widely used treatment option and preliminary studies have shown that treatment with the combination of capecitabine and irinotecan has a positive effect on metastatic colorectal cancer. Likewise, previous research in animals has shown that celecoxib, a drug approved for arthritis therapy, also has activity against this tumor type and may improve the anti-cancer activity of the combination of capecitabine and irinotecan.
>Trial Type >Trial ID >Title >Status >Phase >Start Date >Summary

All Clinical Trials for Celecoxib

Trial ID Title Status Sponsor Phase Start Date Summary
NCT00001693 Phase I-II Multiple-Dose Safety and Efficacy Study of a Selective Inhibitor of Cyclooxygenase - 2 (SC-58635) in Hereditary Non-Polyposis Colorectal Cancer (HNPCC) Patients and Carriers Completed National Cancer Institute (NCI) Phase 1 1998-03-01 This is a randomized, placebo-controlled Phase I/II multi-center trial, of the safety and efficacy of Celecoxib in a cohort of 81 HNPCC subjects and gene carriers. The three proposed intervention arms are: Celecoxib (to be provided by Searle) will be administered at 200mg p.o. BID x 12 months or 400mg p.o. BID x 12 months vs. Placebo p.o. BID x 12 months. Assessment of endoscopic and tissue-based biomarker endpoints will be conducted at baseline and 12 months on study drug or placebo. Patients that present with polyps at baseline will undergo a month 4 endoscopy. Plasma drug trough samples for pharmacokinetic analyses will be collected at baseline and month 12. NCI-Chemoprevention Branch will coordinate the efforts and activities of all sites. Safety monitoring will occur via in-patient interviews with exams at month twelve; symptom questionnaires completed at baseline, months one, four, eight and twelve; blood and urinalysis at baseline and at months one, four, eight and twelve. A post-administration telephone call to evaluate side effect resolution will occur at months 13-14 for patients who have unresolved adverse events at the end of month 12.
NCT00001955 Study of Etanercept and Celecoxib to Treat Temporomandibular Disorders (Painful Joint Conditions) Completed National Institute of Dental and Craniofacial Research (NIDCR) Phase 2 1999-12-01 This 2-part study will evaluate the effectiveness and side effects of two anti-inflammatory drugs for relieving pain and improving jaw function in patients with temporomandibular disorder (TMD). Part 1 will evaluate celecoxib (Celebrex); Part 2 will evaluate etanercept (Enbrel). The Food and Drug Administration has approved both of these drugs for treating certain forms of arthritis. Patients between the ages of 18 and 65 years with painful jaw joint conditions may be eligible for this study. Candidates will complete several written questionnaires about their jaw condition and will undergo a medical history, complete TMD evaluation, blood and urine tests, and imaging studies of the temporomandibular joint, such as X-rays and magnetic resonance imaging. Patients will rate the quality and intensity of their pain before beginning treatment. At certain periods during the study, they will also keep a pain diary, twice a day recording the intensity and magnitude of their pain. Part 1 - Celecoxib: Patients will be randomly assigned to receive either 1) celecoxib twice a day by mouth; 2) naproxen (a non-steroidal anti-inflammatory drug) twice a day by mouth; or 3) a placebo (inactive pill) twice a day by mouth. Part 2 - Etanercept: Patients will be randomly assigned to receive either 1) etanercept injected under the skin or 2) saline (an inactive placebo) injected under the skin. Patients in this group will also undergo two aspirations of fluid from the jaw joint - once before treatment begins and again 6 weeks later. For this procedure, the joint is numbed with an anesthetic and then a needle is inserted into the jaw space to withdraw fluid, which will be analyzed for inflammatory processes in the joint. All patients will have a final evaluation 6 weeks after beginning treatment, including a TMD physical examination, laboratory and X-ray tests as required. The pain diary and questionnaires will be collected at this visit.
NCT00005094 Celecoxib to Prevent Colorectal Cancer in Patients Who Have Undergone Surgery to Remove Polyps Completed National Cancer Institute (NCI) Phase 3 2000-03-01 Chemoprevention therapy is the use of certain drugs to try to prevent the development of cancer. The use of celecoxib has been approved for use in reducing the number of adenomatous colorectal polyps in familial adenomatous polyposis (FAP). It is not known whether there is a clinical benefit from a reduction in the number of colorectal polyps in FAP patients. The use of celecoxib may be an effective way to prevent the development of sporadic adenomatous polyps, precursors of colorectal cancer. This randomized phase III trial is studying celecoxib to see how well it works compared to a placebo in preventing the development of adenomatous colorectal polyps in patients who have had at least one polyp removed.
>Trial ID >Title >Status >Phase >Start Date >Summary

Clinical Trial Conditions for Celecoxib

Condition Name

Condition Name for Celecoxib
Intervention Trials
Osteoarthritis 33
Lung Cancer 23
Breast Cancer 20
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Condition MeSH

Condition MeSH for Celecoxib
Intervention Trials
Osteoarthritis 67
Colorectal Neoplasms 34
Osteoarthritis, Knee 34
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Clinical Trial Locations for Celecoxib

Trials by Country

Trials by Country for Celecoxib
Location Trials
Canada 86
United Kingdom 80
Japan 54
Brazil 46
Mexico 27
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Trials by US State

Trials by US State for Celecoxib
Location Trials
New York 65
Texas 61
California 57
Pennsylvania 50
Illinois 49
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Clinical Trial Progress for Celecoxib

Clinical Trial Phase

Clinical Trial Phase for Celecoxib
Clinical Trial Phase Trials
Phase 4 100
Phase 3 87
Phase 2/Phase 3 11
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Clinical Trial Status

Clinical Trial Status for Celecoxib
Clinical Trial Phase Trials
Completed 227
Recruiting 72
Not yet recruiting 60
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Clinical Trial Sponsors for Celecoxib

Sponsor Name

Sponsor Name for Celecoxib
Sponsor Trials
National Cancer Institute (NCI) 96
Pfizer 76
M.D. Anderson Cancer Center 11
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Sponsor Type

Sponsor Type for Celecoxib
Sponsor Trials
Other 451
Industry 171
NIH 113
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