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Last Updated: December 14, 2024

505(b)(2) Clinical Trials for New Combination Drugs


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Drug(s) Trial Type Trial ID Title Status Sponsor Phase Start Date Summary
  • ADEFOVIR DIPIVOXIL
  • DIDANOSINE
  • EFAVIRENZ
  • EPIVIR
  • EPIVIR-HBV
  • LAMIVUDINE
  • SUSTIVA
  • New Combination NCT00002234 ↗ Safety and Effectiveness of Giving an Anti-HIV Drug Combination of Adefovir Dipivoxil Plus Didanosine Plus Efavirenz Plus Lamivudine Once Daily to HIV-Infected Patients Completed Bristol-Myers Squibb Phase 2 1969-12-31 The purpose of this study is to see if it is safe and effective to give HIV-infected patients a new combination of anti-HIV drugs taken once daily.
  • CISPLATIN
  • GEMCITABINE HYDROCHLORIDE
  • PACLITAXEL
  • New Combination NCT00003589 ↗ Combination Chemotherapy in Treating Patients With Advanced Non-small Cell Lung Cancer Completed European Organisation for Research and Treatment of Cancer - EORTC Phase 3 1998-08-01 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. It is not yet known which combination chemotherapy regimen is more effective in treating advanced non-small cell lung cancer. PURPOSE: Randomized phase III trial to compare the effectiveness of three different combination chemotherapy regimens in treating patients who have advanced non-small cell lung cancer.
  • ZINC CHLORIDE
  • ZINC CHLORIDE IN PLASTIC CONTAINER
  • New Combination NCT00016744 ↗ Phenylbutyrate/Genistein Duotherapy in Delta F508-Homozygous(for Cystic Fibrosis) Completed Cystic Fibrosis Foundation Phase 1/Phase 2 2001-09-01 We are testing a new combination of medicines, to determine if they could be used to treat cystic fibrosis (CF). Subjects with CF who have two copies of the most common mutation (change) found in patients with CF called DF508. CF is caused by a lack of chloride movement in the nose, sinuses, lungs, intestines, pancreas and sweat glands. We are conducting this study to determine the safety of using a combination of two medicines, Phenylbutyrate and Genistein, to improve the ability of the cells lining the nose to regulate movement of salt (chloride) and water in people with CF. Phenylbutyrate has been extensively used to treat patients with rare metabolic diseases (which are very different from CF), Phenylbutyrate is an investigational drug for the purpose of this study. Genistein is a naturally occurring substance that is found in food products such as soy and tofu, but is also an investigational drug for this study. Both drugs may be able to restore normal chloride movements in body organs and glands. We will be studying salt and water in the nose movement by a technique called nasal transepithelial potential difference (NPD).
  • BORTEZOMIB
  • DEXAMETHASONE
  • MELPHALAN
  • MELPHALAN HYDROCHLORIDE
  • PREDNISONE
  • THALIDOMIDE
  • VELCADE
  • New Combination NCT00116961 ↗ Velcade, Doxil, and Dexamethasone (VDd) as First Line Therapy for Multiple Myeloma Completed University of Michigan Cancer Center Phase 2 2005-06-01 This is a research study for patients with newly diagnosed multiple myeloma. Multiple myeloma remains a non-curable disease however, newer medications and their combinations appear to provide higher response rates and higher complete response rates than current treatment options. One of the new medications in multiple myeloma is Velcade. Preliminary results from a study using a combination of Velcade with Doxil have shown high response rates (disease reduction). Preliminary results also show that an addition of dexamethasone to Velcade in patients not responding to Velcade alone showed improved response rates. This study involves treatment with a new combination of three standard medications: Velcade, Doxil, and dexamethasone (VDd combination). The proposed combination of all three drugs may improve efficacy and response. Velcade is approved by the Food and Drug Administration (FDA) for treatment in multiple myeloma patients who have received at least two prior therapies and have demonstrated disease progression on the last therapy. Velcade is still currently under investigation for other indications. Doxil is not approved for use in multiple myeloma but is an approved drug for use in patients with some other cancers. Several published clinical trials provide evidence that Doxil is an active agent in multiple myeloma and it is used in treatment combinations for multiple myeloma in general practice. Dexamethasone is a standard therapy for multiple myeloma, but is not approved by the FDA for that use. The combination of all three drugs is experimental (not FDA approved). The goals of this study are to determine if this new combination therapy with Velcade, Doxil and dexamethasone is an effective treatment and also to determine the side effects that occur when this combination treatment is given.
  • CARBOPLATIN
  • CISPLATIN
  • DOCETAXEL
  • ERLOTINIB HYDROCHLORIDE
  • PACLITAXEL
  • TARCEVA
  • New Combination NCT00130520 ↗ Bevacizumab and Erlotinib Study in Advanced Ovarian Cancer Completed Genentech, Inc. Phase 2 2005-06-01 The purpose of this project is to determine if a new combination of drugs, erlotinib (Tarceva™) and bevacizumab is safe and effective for treating women diagnosed with ovarian cancer whose cancer has progressed while on prior standard chemotherapy treatment with a taxane (paclitaxel or docetaxel) and a platinum (cisplatin or carboplatin).
  • BORTEZOMIB
  • DEXAMETHASONE
  • DOXORUBICIN HYDROCHLORIDE
  • VELCADE
  • New Combination NCT00135187 ↗ Study of Combination Therapy With VELCADE, Doxil, and Dexamethasone (VDd) in Multiple Myeloma Completed University of Michigan Cancer Center N/A 2004-07-01 Patients are being asked to take part in this research study because they have multiple myeloma which has relapsed after (come back), or is refractory to (unaffected by), initial therapy. For patients who have relapsed or are refractory to therapy, there is no agreed upon standard treatment. Treatment options include chemotherapy and, for some patients, bone marrow transplants. None of the available treatments are curative and investigators are continually looking for more effective treatments. This study involves treatment with a new combination of standard drugs: VELCADE, Doxil, and Dexamethasone. Preliminary results from a study using a combination of VELCADE with Doxil showed high response rates (disease reduction). Two other studies showed that an addition of Dexamethasone to VELCADE in patients not responding to VELCADE alone improved response rate. The proposed combination of all three drugs may improve efficacy and response. VELCADE is approved by the Food and Drug Administration (FDA) for use in multiple myeloma. Doxil is not approved for use in multiple myeloma but is an approved drug for use in patients with some other cancers. Several published clinical trials provide evidence that Doxil is an active agent in multiple myeloma and it is used in treatment combinations for multiple myeloma in general practice. Dexamethasone is approved for use in multiple myeloma. The combination of all three drugs is experimental (not FDA approved). The goals of this study are to determine if this new combination therapy with VELCADE, Doxil and Dexamethasone is an effective treatment, and also to determine the side effects that occur when this combination treatment is given.
  • AMARYL
  • GLIMEPIRIDE
  • INSULIN
  • INSULIN HUMAN
  • INSULIN PORK
  • INSULIN PURIFIED BEEF
  • INSULIN PURIFIED PORK
  • INSULIN RECOMBINANT HUMAN
  • INSULIN RECOMBINANT PURIFIED HUMAN
  • INSULIN ZINC SUSP BEEF
  • INSULIN ZINC SUSP EXTENDED BEEF
  • INSULIN ZINC SUSP EXTENDED PURIFIED BEEF
  • INSULIN ZINC SUSP EXTENDED RECOMBINANT HUMAN
  • INSULIN ZINC SUSP PURIFIED BEEF
  • INSULIN ZINC SUSP PURIFIED BEEF/PORK
  • INSULIN ZINC SUSP PURIFIED PORK
  • INSULIN ZINC SUSP RECOMBINANT HUMAN
  • LANTUS
  • LENTE INSULIN
  • METFORMIN HYDROCHLORIDE
  • NPH INSULIN
  • REGULAR INSULIN
  • REGULAR PURIFIED PORK INSULIN
  • New Combination NCT00151697 ↗ LANN-study: Lantus, Amaryl, Novorapid, Novomix Study Completed Rijnstate Hospital Phase 3 2005-05-01 Many diabetics gain weight while on insulin therapy. In this study, we evaluate the efficacy of the combination of glimepiride and short-acting insulin on weight control and glucose control. In this study, 150 diabetics whose diabetic control is inadequate while on maximal oral treatment will be randomized to either the new combination treatment or twice daily injections with a mixture of short- and longacting insulin or once-daily injection with a basal insulin analog. The study will compare glucose control and weight gain during a year after randomisation between the three treatments.
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