CLINICAL TRIALS PROFILE FOR CELECOXIB
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505(b)(2) Clinical Trials for CELECOXIB
| 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. |
| New Combination | NCT00230399 ↗ | Combination Chemotherapy Treatments in Patients With Metastatic Colorectal Cancer | Completed | University of Michigan Rogel 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. |
| New Formulation | NCT00925106 ↗ | Pharmacokinetics Of Celecoxib Test Formulations | Completed | Pfizer | Phase 1 | 2009-07-01 | The pharmacokinetics of new formulations of celecoxib are being evaluated. They are expected to provide more favorable bioavailability characteristics than the present commercial formulation. |
| New Formulation | NCT00925106 ↗ | Pharmacokinetics Of Celecoxib Test Formulations | Completed | Pfizer's Upjohn has merged with Mylan to form Viatris Inc. | Phase 1 | 2009-07-01 | The pharmacokinetics of new formulations of celecoxib are being evaluated. They are expected to provide more favorable bioavailability characteristics than the present commercial formulation. |
| >Trial Type | >Trial ID | >Title | >Status | >Sponsor | >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. |
| NCT00005878 ↗ | Celecoxib to Prevent Cancer in Patients With Barrett's Esophagus | Completed | National Cancer Institute (NCI) | Phase 2 | 2000-07-01 | RATIONALE: Chemoprevention therapy is the use of certain drugs to try to prevent the development or recurrence of cancer. Celecoxib may be effective in preventing cancer in patients with Barrett's esophagus. PURPOSE: Randomized phase II trial to study the effectiveness of celecoxib in preventing cancer in patients who have Barrett's esophagus. |
| NCT00005878 ↗ | Celecoxib to Prevent Cancer in Patients With Barrett's Esophagus | Completed | Sidney Kimmel Comprehensive Cancer Center | Phase 2 | 2000-07-01 | RATIONALE: Chemoprevention therapy is the use of certain drugs to try to prevent the development or recurrence of cancer. Celecoxib may be effective in preventing cancer in patients with Barrett's esophagus. PURPOSE: Randomized phase II trial to study the effectiveness of celecoxib in preventing cancer in patients who have Barrett's esophagus. |
| NCT00005878 ↗ | Celecoxib to Prevent Cancer in Patients With Barrett's Esophagus | Completed | Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins | Phase 2 | 2000-07-01 | RATIONALE: Chemoprevention therapy is the use of certain drugs to try to prevent the development or recurrence of cancer. Celecoxib may be effective in preventing cancer in patients with Barrett's esophagus. PURPOSE: Randomized phase II trial to study the effectiveness of celecoxib in preventing cancer in patients who have Barrett's esophagus. |
| >Trial ID | >Title | >Status | >Sponsor | >Phase | >Start Date | >Summary |
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