Bosutinib (DrugBank: Bosutinib)
2 diseases| ID | Disease name (Link within this page) | Number of trials |
|---|---|---|
| 2 | Amyotrophic lateral sclerosis | 3 |
| 67 | Polycystic kidney disease | 11 |
| No. | TrialID | Date_ enrollment | Date_ registration | Public_title | Scientific_title | Condition | Intervention | Primary_ sponsor | Secondary_ sponsor | Recruitment_ Status | Inclusion_ agemin | Inclusion_ agemax | Inclusion_ gender | Target_ size | Phase | Countries |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 1 | JPRN-UMIN000036295 | 2019/03/29 | 26/03/2019 | Phase 1 Dose Escalation Study of Bosutinib in Patients with Amyotrophic Lateral Sclerosis (ALS) | Phase 1 Dose Escalation Study of Bosutinib in Patients with Amyotrophic Lateral Sclerosis (ALS) - Phase 1 Dose Escalation Study of Bosutinib in Patients with Amyotrophic Lateral Sclerosis (ALS) | Amyotrophic Lateral Sclerosis | The study consists of a 12-week observation period, a 1-week (5- to 9-day) transitional period, a 12-week study treatment period, and a 4-week follow-up period. 3 to 6 ALS patients will be enrolled in each of the 4 bosutinib dose levels [100 mg/day (dose level 1), 200 mg/day (dose level 2), 300 mg/day (dose level 3), or 400mg/day (dose level 4)] to evaluate the safety and tolerability of the investigational drug (bosutinib) under a 3+3 dose escalation study design. | Center for iPS Cell Research and Application, Kyoto University | Provider of the investigational product: Pfizer Japan Inc. | Recruiting | 20years-old | 80years-old | Male and Female | 24 | Phase 1 | Japan |
| 2 | JPRN-jRCT2051190001 | 29/03/2019 | 01/04/2019 | Phase 1 Dose Escalation Study of Bosutinib in Patients with Amyotrophic Lateral Sclerosis (ALS) | Phase 1 Dose Escalation Study of Bosutinib in Patients with Amyotrophic Lateral Sclerosis (ALS) - Phase 1 Dose Escalation Study of Bosutinib in Patients with Amyotrophic Lateral Sclerosis (ALS) | amyotrophic lateral sclerosis ALS | The study consists of a 12-week observation period, a 1-week (5- to 9-day) transitional period, a 12-week study treatment period, and a 4-week follow-up period. 3 to 6 ALS patients will be enrolled in each of the 4 bosutinib dose levels [100 mg/day (dose level 1), 200 mg/day (dose level 2), 300 mg/day (dose level 3), or 400mg/day (dose level 4)] to evaluate the safety and tolerability of the investigational drug (bosutinib) under a 3+3 dose escalation study design. | Inoue Haruhisa | NULL | Recruiting | 20age | 79age | Both | 24 | Phase 1 | Japan |
| 3 | JPRN-JMA-IIA00419 | 29/03/2019 | 29/03/2019 | Phase 1 dose-escalation study of bosutinib in patients with amyotrophic lateral sclerosis (ALS) | Phase 1 dose-escalation study of bosutinib in patients with amyotrophic lateral sclerosis (ALS) | Amyotrophic Lateral Sclerosis | Intervention type:DRUG. Intervention1:Medicine, Dose form:TABLET, Route of administration:ORAL, intended dose regimen:The study consists of a 12-week observation period, a 1-week (5- to 9-day) transitional period, a 12-week study treatment period, and a 4-week follow-up period. . | Center for iPS Cell Research and Application (CiRA), Kyoto University | NULL | Recruiting | >=20 YEARS | <80 YEARS | BOTH | 24 | Phase 1 | Japan |
| No. | TrialID | Date_ enrollment | Date_ registration | Public_title | Scientific_title | Condition | Intervention | Primary_ sponsor | Secondary_ sponsor | Recruitment_ Status | Inclusion_ agemin | Inclusion_ agemax | Inclusion_ gender | Target_ size | Phase | Countries |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 1 | EUCTR2010-023017-65-BG (EUCTR) | 14/05/2012 | 22/05/2012 | A multicenter, randomized, double-blind, placebo-controlled study of the safety, effectiveness, and pharmacokinetics of bosutinib versus placebo in subjects with polycystic kidney disease | A PHASE 2, MULTICENTER, RANDOMIZED, DOUBLE-BLIND, PLACEBO-CONTROLLED STUDY OF THE SAFETY, CLINICAL ACTIVITY AND PHARMACOKINETICS OF BOSUTINIB (PF-05208763) VERSUS PLACEBO IN SUBJECTS WITH AUTOSOMAL DOMINANT POLYCYSTIC KIDNEY DISEASE (ADPKD) | Autosomal Dominant Polycystic Kidney Disease (ADPKD) MedDRA version: 14.1;Level: LLT;Classification code 10036046;Term: Polycystic kidney, autosomal dominant;System Organ Class: 10010331 - Congenital, familial and genetic disorders;Therapeutic area: Diseases [C] - Congenital, Hereditary, and Neonatal Diseases and Abnormalities [C16] | Product Name: Bosutinib Product Code: PF-05208763 INN or Proposed INN: Bosutinib (anhydrous) Other descriptive name: SKI-606 Product Name: Bosutinib Product Code: PF-05208763 INN or Proposed INN: Bosutinib (anhydrous) Other descriptive name: SKI-606 Product Name: Bosutinib Product Code: PF-05208763 INN or Proposed INN: Bosutinib (anhydrous) Other descriptive name: SKI-606 | Pfizer Inc., 235 East 42nd Street, New York, NY 10017 | NULL | Not Recruiting | Female: yes Male: yes | 275 | Phase 2 | United States;Slovakia;Spain;Korea, Democratic People's Republic of;Lithuania;Turkey;Italy;Switzerland;United Kingdom;Hungary;Czech Republic;Canada;Poland;Romania;Australia;Bulgaria;Moldova, Republic of;Japan;Sweden | ||
| 2 | EUCTR2010-023017-65-LT (EUCTR) | 14/11/2011 | 02/09/2011 | A PHASE 2, MULTICENTER, RANDOMIZED, DOUBLE-BLIND, PLACEBO-CONTROLLED STUDY OF THE SAFETY, CLINICAL ACTIVITY AND PHARMACOKINETICS OF BOSUTINIB (PF-05208763) VERSUS PLACEBO IN SUBJECTS WITH AUTOSOMAL DOMINANT POLYCYSTIC KIDNEY DISEASE (ADPKD) | A PHASE 2, MULTICENTER, RANDOMIZED, DOUBLE-BLIND, PLACEBO-CONTROLLED STUDY OF THE SAFETY, CLINICAL ACTIVITY AND PHARMACOKINETICS OF BOSUTINIB (PF-05208763) VERSUS PLACEBO IN SUBJECTS WITH AUTOSOMAL DOMINANT POLYCYSTIC KIDNEY DISEASE (ADPKD) | Autosomal Dominant Polycystic Kidney Disease (ADPKD) MedDRA version: 16.1;Level: LLT;Classification code 10036046;Term: Polycystic kidney, autosomal dominant;System Organ Class: 100000004850 | Product Name: Bosutinib Product Code: PF-05208763 INN or Proposed INN: Bosutinib (anhydrous) Other descriptive name: SKI-606 | Pfizer Inc., 235 East 42nd Street, New York, NY 10017 | NULL | Not Recruiting | Female: yes Male: yes | 275 | Phase 2 | Hungary;Czech Republic;Slovakia;Poland;Spain;Lithuania;Italy;United Kingdom;Sweden | ||
| 3 | EUCTR2010-023017-65-IT (EUCTR) | 28/10/2011 | 14/03/2012 | A multicenter, randomized, double-blind, placebo-controlled study of the safety, effectiveness and pharmacokinetics of bosutinib versus placebo in subjects with polycystic kidney disease | A Phase 2, multicenter, randomized, double-blind, placebo-controlled study of the safety, clinical activity and pharmacokinetics of bosutinib (PF 05208763) versus placebo in subjects with autosomal dominant polycystic kidney disease (ADPKD). | Autosomal Dominant Polycystic Kidney Disease (ADPKD) MedDRA version: 14.1;Level: LLT;Classification code 10036046;Term: Polycystic kidney, autosomal dominant;System Organ Class: 10010331 - Congenital, familial and genetic disorders;Therapeutic area: Diseases [C] - Congenital, Hereditary, and Neonatal Diseases and Abnormalities [C16] | Product Name: Bosutinib Product Code: PF-05208763 INN or Proposed INN: BOSUTINIB Other descriptive name: SKI-606 | PFIZER INC. | NULL | Not Recruiting | Female: yes Male: yes | 275 | Phase 2 | United States;Slovakia;Spain;Korea, Democratic People's Republic of;Lithuania;Turkey;Italy;Switzerland;United Kingdom;Czech Republic;Hungary;Canada;Poland;Australia;Japan;Sweden | ||
| 4 | EUCTR2010-023017-65-GB (EUCTR) | 02/08/2011 | 08/04/2011 | A multicenter, randomized, double-blind, placebo-controlled study of the safety, effectiveness, and pharmacokinetics of bosutinib versus placebo in subjects with polycystic kidney disease | A PHASE 2, MULTICENTER, RANDOMIZED, DOUBLE-BLIND, PLACEBO-CONTROLLED STUDY OF THE SAFETY, CLINICAL ACTIVITY AND PHARMACOKINETICS OF BOSUTINIB (PF-05208763) VERSUS PLACEBO IN SUBJECTS WITH AUTOSOMAL DOMINANT POLYCYSTIC KIDNEY DISEASE (ADPKD) | Autosomal Dominant Polycystic Kidney Disease (ADPKD) MedDRA version: 20.0;Level: LLT;Classification code 10036046;Term: Polycystic kidney, autosomal dominant;System Organ Class: 100000004850 ;Therapeutic area: Diseases [C] - Congenital, Hereditary, and Neonatal Diseases and Abnormalities [C16] | Pfizer Inc., 235 East 42nd Street, New York, NY 10017 | NULL | Not Recruiting | Female: yes Male: yes | 275 | Phase 2 | United States;Slovakia;Spain;Korea, Democratic People's Republic of;Lithuania;Turkey;Italy;United Kingdom;Switzerland;France;Czech Republic;Hungary;Canada;Poland;Romania;Australia;Bulgaria;Germany;Japan;Sweden | |||
| 5 | EUCTR2010-023017-65-CZ (EUCTR) | 16/06/2011 | 01/02/2011 | A multicenter, randomized, double-blind, placebo-controlled study of the safety, effectiveness, and pharmacokinetics of bosutinib versus placebo in subjects with polycystic kidney disease | A PHASE 2, MULTICENTER, RANDOMIZED, DOUBLE-BLIND, PLACEBO-CONTROLLED STUDY OF THE SAFETY, CLINICAL ACTIVITY AND PHARMACOKINETICS OF BOSUTINIB (PF-05208763) VERSUS PLACEBO IN SUBJECTS WITH AUTOSOMAL DOMINANT POLYCYSTIC KIDNEY DISEASE (ADPKD) | Autosomal Dominant Polycystic Kidney Disease (ADPKD) MedDRA version: 14.1;Level: LLT;Classification code 10036046;Term: Polycystic kidney, autosomal dominant;System Organ Class: 100000004850;Therapeutic area: Diseases [C] - Congenital, Hereditary, and Neonatal Diseases and Abnormalities [C16] | Product Name: Bosutinib Product Code: PF-05208763 INN or Proposed INN: Bosutinib (anhydrous) Other descriptive name: SKI-606 | Pfizer Inc. | NULL | Not Recruiting | Female: yes Male: yes | 190 | Phase 2 | United States;Slovakia;Spain;Korea, Democratic People's Republic of;Turkey;Lithuania;United Kingdom;Switzerland;Italy;Czech Republic;Hungary;Canada;Poland;Romania;Australia;Bulgaria;Japan;Moldova, Republic of;Sweden | ||
| No. | TrialID | Date_ enrollment | Date_ registration | Public_title | Scientific_title | Condition | Intervention | Primary_ sponsor | Secondary_ sponsor | Recruitment_ Status | Inclusion_ agemin | Inclusion_ agemax | Inclusion_ gender | Target_ size | Phase | Countries |
| 6 | EUCTR2010-023017-65-HU (EUCTR) | 27/05/2011 | 05/04/2011 | A multicenter, randomized, double-blind, placebo-controlled study of the safety, effectiveness, and pharmacokinetics of bosutinib versus placebo in subjects with polycystic kidney disease | A PHASE 2, MULTICENTER, RANDOMIZED, DOUBLE-BLIND, PLACEBO-CONTROLLED STUDY OF THE SAFETY, CLINICAL ACTIVITY AND PHARMACOKINETICS OF BOSUTINIB (PF-05208763) VERSUS PLACEBO IN SUBJECTS WITH AUTOSOMAL DOMINANT POLYCYSTIC KIDNEY DISEASE (ADPKD) | Autosomal Dominant Polycystic Kidney Disease (ADPKD) MedDRA version: 16.1;Level: LLT;Classification code 10036046;Term: Polycystic kidney, autosomal dominant;System Organ Class: 100000004850;Therapeutic area: Diseases [C] - Congenital, Hereditary, and Neonatal Diseases and Abnormalities [C16] | Product Name: Bosutinib Product Code: PF-05208763 INN or Proposed INN: Bosutinib (anhydrous) Other descriptive name: SKI-606 | Pfizer Inc., 235 East 42nd Street, New York, NY 10017 | NULL | Not Recruiting | Female: yes Male: yes | 190 | Phase 2 | United States;Slovakia;Spain;Korea, Democratic People's Republic of;Turkey;Lithuania;United Kingdom;Switzerland;Italy;France;Hungary;Czech Republic;Canada;Poland;Romania;Australia;Germany;Japan;Moldova, Republic of;Sweden | ||
| 7 | EUCTR2010-023017-65-SK (EUCTR) | 25/05/2011 | 28/04/2011 | A multicenter, randomized, double-blind, placebo-controlled study of the safety, effectiveness, and pharmacokinetics of bosutinib versus placebo in subjects with polycystic kidney disease | A PHASE 2, MULTICENTER, RANDOMIZED, DOUBLE-BLIND, PLACEBO-CONTROLLED STUDY OF THE SAFETY, CLINICAL ACTIVITY AND PHARMACOKINETICS OF BOSUTINIB (PF-05208763) VERSUS PLACEBO IN SUBJECTS WITH AUTOSOMAL DOMINANT POLYCYSTIC KIDNEY DISEASE (ADPKD) | Autosomal Dominant Polycystic Kidney Disease (ADPKD) MedDRA version: 16.0;Level: LLT;Classification code 10036046;Term: Polycystic kidney, autosomal dominant;System Organ Class: 100000004850;Therapeutic area: Diseases [C] - Congenital, Hereditary, and Neonatal Diseases and Abnormalities [C16] | Product Name: Bosutinib Product Code: PF-05208763 INN or Proposed INN: Bosutinib (anhydrous) Other descriptive name: SKI-606 | Pfizer Inc., 235 East 42nd Street, New York, NY 10017 | NULL | Not Recruiting | Female: yes Male: yes | 190 | Phase 2 | United States;Slovakia;Spain;Korea, Democratic People's Republic of;Lithuania;Turkey;Italy;Switzerland;United Kingdom;Hungary;Czech Republic;Canada;Poland;Romania;Australia;Bulgaria;Moldova, Republic of;Japan;Sweden | ||
| 8 | EUCTR2010-023017-65-PL (EUCTR) | 21/04/2011 | 12/04/2011 | A multicenter, randomized, double-blind, placebo-controlled study of thesafety, effectiveness, and pharmacokinetics of bosutinib versus placebo insubjects with polycystic kidney disease | A PHASE 2, MULTICENTER, RANDOMIZED, DOUBLE-BLIND, PLACEBO-CONTROLLED STUDY OF THE SAFETY, CLINICAL ACTIVITY AND PHARMACOKINETICS OF BOSUTINIB (PF-05208763) VERSUS PLACEBO IN SUBJECTS WITH AUTOSOMAL DOMINANT POLYCYSTIC KIDNEY DISEASE (ADPKD) | Autosomal Dominant Polycystic Kidney Disease (ADPKD) MedDRA version: 16.1;Level: LLT;Classification code 10036046;Term: Polycystic kidney, autosomal dominant;System Organ Class: 100000004850 | Product Name: Bosutinib Product Code: PF-05208763 INN or Proposed INN: Bosutinib (anhydrous) Other descriptive name: SKI-606 | Pfizer Inc., 235 East 42nd Street, New York, NY 10017 | NULL | Not Recruiting | Female: yes Male: yes | 275 | Phase 2 | Hungary;Czech Republic;Slovakia;Spain;Poland;Lithuania;Italy;United Kingdom;Sweden | ||
| 9 | EUCTR2010-023017-65-ES (EUCTR) | 18/03/2011 | 27/01/2011 | ESTUDIO EN FASE 2, MULTICÉNTRICO, ALEATORIZADO, DOBLE CIEGO Y CONTROLADO CON PLACEBO DE LA SEGURIDAD, LA ACTIVIDAD CLÍNICA Y LA FARMACOCINÉTICA DE BOSUTINIB (PF-05208763) FRENTE A PLACEBO EN SUJETOS CON POLIQUISTOSIS RENAL AUTOSÓMICA DOMINANTE (PRAD). - A Phase 2, multicenter, randomized, double-blind, placebo-controlled study of the safety, clinical activity and pharmacokinetics of bosutinib (PF-05208763) versus placebo in subjects with autosomal dominant polycystic kidney disease (ADPKD). | ESTUDIO EN FASE 2, MULTICÉNTRICO, ALEATORIZADO, DOBLE CIEGO Y CONTROLADO CON PLACEBO DE LA SEGURIDAD, LA ACTIVIDAD CLÍNICA Y LA FARMACOCINÉTICA DE BOSUTINIB (PF-05208763) FRENTE A PLACEBO EN SUJETOS CON POLIQUISTOSIS RENAL AUTOSÓMICA DOMINANTE (PRAD). - A Phase 2, multicenter, randomized, double-blind, placebo-controlled study of the safety, clinical activity and pharmacokinetics of bosutinib (PF-05208763) versus placebo in subjects with autosomal dominant polycystic kidney disease (ADPKD). | Poliquistosis renal autosómica dominante (PRAD). MedDRA version: 12.1;Level: LLT;Classification code 10036046;Term: Polycystic kidney, autosomal dominant | Product Name: Bosutinib Product Code: PF-05208763 INN or Proposed INN: Bosutinib (anhydrous) Other descriptive name: SKI-606 | PFIZER, S.L.U. | NULL | Not Recruiting | Female: yes Male: yes | 275 | Phase 2 | Hungary;Czech Republic;Slovakia;Poland;Spain;Lithuania;Italy;United Kingdom;Sweden | ||
| 10 | EUCTR2010-023017-65-SE (EUCTR) | 17/03/2011 | 20/01/2011 | A multicenter, randomized, double-blind, placebo-controlled study of the safety, effectiveness, and pharmacokinetics of bosutinib versus placebo in subjects with polycystic kidney disease | A PHASE 2, MULTICENTER, RANDOMIZED, DOUBLE-BLIND, PLACEBO-CONTROLLED STUDY OF THE SAFETY, CLINICAL ACTIVITY AND PHARMACOKINETICS OF BOSUTINIB (PF-05208763) VERSUS PLACEBO IN SUBJECTS WITH AUTOSOMAL DOMINANT POLYCYSTIC KIDNEY DISEASE (ADPKD) | Autosomal Dominant Polycystic Kidney Disease (ADPKD) MedDRA version: 14.1;Level: LLT;Classification code 10036046;Term: Polycystic kidney, autosomal dominant;System Organ Class: 100000004850;Therapeutic area: Diseases [C] - Congenital, Hereditary, and Neonatal Diseases and Abnormalities [C16] | Product Name: Bosutinib Product Code: PF-05208763 INN or Proposed INN: Bosutinib (anhydrous) Other descriptive name: SKI-606 | Pfizer Inc., 235 East 42nd Street, New York, NY 10017 | NULL | Not Recruiting | Female: yes Male: yes | 190 | Phase 2 | United States;Slovakia;Spain;Korea, Democratic People's Republic of;Lithuania;Turkey;Italy;Switzerland;United Kingdom;Hungary;Czech Republic;Canada;Poland;Romania;Australia;Bulgaria;Moldova, Republic of;Japan;Sweden | ||
| No. | TrialID | Date_ enrollment | Date_ registration | Public_title | Scientific_title | Condition | Intervention | Primary_ sponsor | Secondary_ sponsor | Recruitment_ Status | Inclusion_ agemin | Inclusion_ agemax | Inclusion_ gender | Target_ size | Phase | Countries |
| 11 | NCT01233869 (ClinicalTrials.gov) | December 2010 | 28/10/2010 | Bosutinib For Autosomal Dominant Polycystic Kidney Disease | A Phase 2, Multicenter, Randomized, Double-Blind, Placebo-Controlled Study Of The Safety, Clinical Activity And Pharmacokinetics Of Bosutinib (PF-05208763) Versus Placebo In Subjects With Autosomal Dominant Polycystic Kidney Disease (ADPKD) | Polycystic Kidney, Autosomal Dominant | Drug: Bosutinib;Drug: Placebo | Pfizer | NULL | Completed | 18 Years | 50 Years | All | 172 | Phase 2 | United States;Australia;Canada;Czech Republic;Hungary;Italy;Korea, Republic of;Lithuania;Moldova, Republic of;Poland;Romania;Slovakia;Spain;Sweden;Switzerland;Turkey;United Kingdom |