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Last Updated: September 16, 2021

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CLINICAL TRIALS PROFILE FOR DOXIL (LIPOSOMAL)

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505(b)(2) Clinical Trials for Doxil (liposomal)

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 Formulation NCT01073371 ↗ Anesthetic Efficacy of Liposomal Prilocaine in Maxillary Infiltration Anesthesia Completed Conselho Nacional de Desenvolvimento Científico e Tecnológico Phase 1 2008-07-01 This blinded randomized, crossover, three period study aim to evaluate the anesthetic efficacy of liposome-encapsulated 3% prilocaine compared to 3% plain prilocaine and 3% prilocaine with 0,03IU/mL felypressin, after 1.8mL infiltration in the buccal sulcus of the maxillary right canine, in 32 volunteers.
New Formulation NCT01073371 ↗ Anesthetic Efficacy of Liposomal Prilocaine in Maxillary Infiltration Anesthesia Completed Fundação de Amparo à Pesquisa do Estado de São Paulo Phase 1 2008-07-01 This blinded randomized, crossover, three period study aim to evaluate the anesthetic efficacy of liposome-encapsulated 3% prilocaine compared to 3% plain prilocaine and 3% prilocaine with 0,03IU/mL felypressin, after 1.8mL infiltration in the buccal sulcus of the maxillary right canine, in 32 volunteers.
New Formulation NCT01073371 ↗ Anesthetic Efficacy of Liposomal Prilocaine in Maxillary Infiltration Anesthesia Completed University of Campinas, Brazil Phase 1 2008-07-01 This blinded randomized, crossover, three period study aim to evaluate the anesthetic efficacy of liposome-encapsulated 3% prilocaine compared to 3% plain prilocaine and 3% prilocaine with 0,03IU/mL felypressin, after 1.8mL infiltration in the buccal sulcus of the maxillary right canine, in 32 volunteers.
New Formulation NCT01593488 ↗ Liposomal Cytarabine in the Treatment of Central Nervous System Resistant or Relapsed Acute Lymphoblastic Leukemia in Children Recruiting Azienda Ospedaliera Universitaria di Bologna Policlinico S. Orsola Malpighi Phase 2 2012-03-01 The purpose of this study is to describe the activity and toxicity of a new formulation of cytarabine called liposomal cytarabine given into the central nervous system for the treatment of central nervous system localization of acute lymphoblastic leukemia (ALL) in children and adolescents.
New Formulation NCT01593488 ↗ Liposomal Cytarabine in the Treatment of Central Nervous System Resistant or Relapsed Acute Lymphoblastic Leukemia in Children Recruiting Santobono-Pausilpon Hospital Phase 2 2012-03-01 The purpose of this study is to describe the activity and toxicity of a new formulation of cytarabine called liposomal cytarabine given into the central nervous system for the treatment of central nervous system localization of acute lymphoblastic leukemia (ALL) in children and adolescents.
>Trial Type >Trial ID >Title >Status >Phase >Start Date >Summary

All Clinical Trials for Doxil (liposomal)

Trial ID Title Status Sponsor Phase Start Date Summary
NCT00001059 ↗ Comparison of Liposomal Doxorubicin Used Alone or in Combination With Bleomycin Plus Vincristine in the Treatment of Kaposi's Sarcoma in Patients With AIDS Completed Amgen Phase 2 1969-12-31 To evaluate the safety and efficacy of liposomal doxorubicin hydrochloride ( DOX-SL ) alone or in combination with bleomycin and vincristine in the long-term treatment of AIDS-related Kaposi's sarcoma. To determine whether the 3-drug combination enhances progression-free survival and quality of life. Liposomal formulations of chemotherapeutic agents increase drug accumulation in tumors, which permits disease palliation at relatively low doses and thus decreases some of the dose-limiting toxicity. Multi-agent therapy is considered to be more effective than single-agent therapy; therefore, DOX-SL will be combined with bleomycin and vincristine.
NCT00001059 ↗ Comparison of Liposomal Doxorubicin Used Alone or in Combination With Bleomycin Plus Vincristine in the Treatment of Kaposi's Sarcoma in Patients With AIDS Completed Sequus Pharmaceuticals Phase 2 1969-12-31 To evaluate the safety and efficacy of liposomal doxorubicin hydrochloride ( DOX-SL ) alone or in combination with bleomycin and vincristine in the long-term treatment of AIDS-related Kaposi's sarcoma. To determine whether the 3-drug combination enhances progression-free survival and quality of life. Liposomal formulations of chemotherapeutic agents increase drug accumulation in tumors, which permits disease palliation at relatively low doses and thus decreases some of the dose-limiting toxicity. Multi-agent therapy is considered to be more effective than single-agent therapy; therefore, DOX-SL will be combined with bleomycin and vincristine.
NCT00001059 ↗ Comparison of Liposomal Doxorubicin Used Alone or in Combination With Bleomycin Plus Vincristine in the Treatment of Kaposi's Sarcoma in Patients With AIDS Completed National Institute of Allergy and Infectious Diseases (NIAID) Phase 2 1969-12-31 To evaluate the safety and efficacy of liposomal doxorubicin hydrochloride ( DOX-SL ) alone or in combination with bleomycin and vincristine in the long-term treatment of AIDS-related Kaposi's sarcoma. To determine whether the 3-drug combination enhances progression-free survival and quality of life. Liposomal formulations of chemotherapeutic agents increase drug accumulation in tumors, which permits disease palliation at relatively low doses and thus decreases some of the dose-limiting toxicity. Multi-agent therapy is considered to be more effective than single-agent therapy; therefore, DOX-SL will be combined with bleomycin and vincristine.
NCT00001646 ↗ Voriconazole vs. Amphotericin B in the Treatment of Invasive Aspergillosis Completed National Institute of Allergy and Infectious Diseases (NIAID) Phase 3 1997-08-01 Invasive aspergillosis is a fungal disease which is increasing in incidence with the increase in immunocompromised persons in our population. Persons with prolonged neutropenia secondary to cytotoxic chemotherapies are at the highest risk for acute aspergillosis. Patients undergoing bone marrow transplantation, receiving prolonged corticosteroid or other immunosuppressive therapies, and persons with HIV infection and AIDS are also at risk. Even with antifungal therapy, aspergillosis in its acute invasive forms has a high mortality. In bone marrow transplantation patients and in those whose infection involves the brain, this mortality is greater than 90%. Amphotericin B in its conventional form, is the current standard treatment for this disease. Response to therapy with amphotericin B usually ranges between 20-60% in most studies. The higher response rates are usually seen in those patients who can tolerate this agent for at least 14 days. Because of its nephrotoxicity and other adverse effects, alternatives to conventional amphotericin B have been sought. These currently include liposomal forms of amphotericin B and itraconazole. Although these forms show a decrease in adverse effects, the efficacy of these drugs has not been shown to be equivalent to conventional amphotericin B. Voriconazole is an investigational antifungal drug currently being brought to phase III trials in the US. This azole has been shown active against Aspergillus spp. in vitro, and in animal models and early human trials to be effective against aspergillosis. It has been shown to be well-tolerated and is available in an intravenous and oral formulation. This study will evaluate the efficacy, safety, and toleration of voriconazole compared to conventional therapy with amphotericin B as primary treatment of acute invasive aspergillosis in immunocompromised patients. Patients will be randomized to open-labelled therapy with voriconazole or amphotericin B in a one-to-one ratio.
NCT00002093 ↗ A Randomized Phase III Clinical Trial of Daunoxome Versus Combination Chemotherapy With Adriamycin/Bleomycin/Vincristine (ABV) in the Treatment of HIV-Associated Kaposi's Sarcoma. Completed Nexstar Pharmaceuticals Phase 3 1969-12-31 To compare the toxicity profiles (severity and time to onset from initiation of therapy) between daunorubicin (liposomal) and combination chemotherapy with doxorubicin/bleomycin/vincristine (ABV), with both regimens administered in combination with antiretroviral therapy. To compare the duration of responses, response rates, and times to response.
>Trial ID >Title >Status >Phase >Start Date >Summary

Clinical Trial Conditions for Doxil (liposomal)

Condition Name

Condition Name for Doxil (liposomal)
Intervention Trials
Ovarian Cancer 67
Breast Cancer 56
Pain, Postoperative 39
Multiple Myeloma 26
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Condition MeSH

Condition MeSH for Doxil (liposomal)
Intervention Trials
Ovarian Neoplasms 113
Breast Neoplasms 78
Pain, Postoperative 75
Leukemia 53
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Clinical Trial Locations for Doxil (liposomal)

Trials by Country

Trials by Country for Doxil (liposomal)
Location Trials
Italy 138
China 68
Spain 65
Canada 65
Germany 62
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Trials by US State

Trials by US State for Doxil (liposomal)
Location Trials
California 113
Texas 101
New York 99
Ohio 73
Florida 67
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Clinical Trial Progress for Doxil (liposomal)

Clinical Trial Phase

Clinical Trial Phase for Doxil (liposomal)
Clinical Trial Phase Trials
Phase 4 161
Phase 3 113
Phase 2/Phase 3 19
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Clinical Trial Status

Clinical Trial Status for Doxil (liposomal)
Clinical Trial Phase Trials
Completed 252
Recruiting 198
Not yet recruiting 166
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Clinical Trial Sponsors for Doxil (liposomal)

Sponsor Name

Sponsor Name for Doxil (liposomal)
Sponsor Trials
National Cancer Institute (NCI) 96
M.D. Anderson Cancer Center 27
Pacira Pharmaceuticals, Inc 17
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Sponsor Type

Sponsor Type for Doxil (liposomal)
Sponsor Trials
Other 785
Industry 358
NIH 102
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