Nilotinib (DrugBank: Nilotinib)
5 diseases| 告示番号 | 疾患名（ページ内リンク） | 臨床試験数 |
|---|---|---|
| 6 | パーキンソン病 | 3 |
| 8 | ハンチントン病 | 1 |
| 34 | 神経線維腫症 | 3 |
| 51 | 全身性強皮症 | 1 |
| 86 | 肺動脈性肺高血圧症 | 4 |
| 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 | NCT03205488 (ClinicalTrials.gov) | October 16, 2017 | 28/6/2017 | Nilotinib in Parkinson's Disease | A Randomized, Double-Blind, Placebo-Controlled, Phase IIa, Parallel Group, Two Cohort Study to Define the Safety, Tolerability, Clinical and Exploratory Biological Activity of the Chronic Administration of Nilotinib in Participants With Parkinson's Disease | Parkinson Disease | Drug: Cohort 1:Nilotinib Oral Capsules (150mg or 300mg);Drug: Cohort 2: Nilotinib Oral Capsules (dose to be determined from Cohort 1);Drug: Placebo | Northwestern University | University of Rochester;University of Iowa;Michael J. Fox Foundation for Parkinson's Research | Completed | 40 Years | 79 Years | All | 76 | Phase 2 | United States |
| 2 | NCT02954978 (ClinicalTrials.gov) | January 2017 | 1/11/2016 | Impact of Nilotinib on Safety, Tolerability, Pharmacokinetics and Biomarkers in Parkinson's Disease | A Randomized, Double Blind, Placebo-controlled Study to Evaluate the Impact of Low Doses of Nilotinib Treatment on Safety, Tolerability, Pharmacokinetics and Biomarkers in Parkinson's Disease | Parkinson Disease;Parkinsons Disease With Dementia | Drug: Placebo Oral Capsule;Drug: Nilotinib 150mg oral capsule [Tasigna];Drug: Nilotinib 300mg oral capsule [Tasigna] | Georgetown University | NULL | Active, not recruiting | 40 Years | 90 Years | All | 75 | Phase 2 | United States |
| 3 | NCT02281474 (ClinicalTrials.gov) | November 2014 | 27/10/2014 | Nilotinib in Cognitively Impaired Parkinson Disease Patients 001 | Open Label Dose Escalation of Nilotinib in Cognitively Impaired Parkinson Disease Patients With Elevated Cerebrospinal Fluid and Blood a-Synuclein | Parkinson's Disease;Parkinson's Disease Dementia;Diffuse Lewy Body Disease | Drug: Nilotinib | Georgetown University | NULL | Completed | 40 Years | 90 Years | Both | 12 | Phase 1 | United States |
| 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 | NCT03764215 (ClinicalTrials.gov) | November 15, 2018 | 27/11/2018 | Nilotinib in Huntington's Disease | An Open Label, Phase Ib Study to Evaluate the Impact of Low Doses of Nilotinib Treatment on Safety, Tolerability and Biomarkers in Huntington's Disease | Huntington Disease | Drug: Nilotinib 150 MG | Georgetown University | NULL | Recruiting | 25 Years | 90 Years | All | 10 | Phase 1 | United States |
| 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 | EUCTR2012-003005-10-DK (EUCTR) | 06/06/2013 | 08/05/2013 | LOW-GRADE GLIOMA | PHASE I-II STUDY OF VINBLASTINE IN COMBINATION WITH NILOTINIB IN CHILDREN, ADOLESCENTS, AND YOUNG ADULTS WITH REFRACTORY OR RECURRENT LOW-GRADE GLIOMA - Vinilo | Children, adolescents and young adults with refractory or recurrent low-grade gliomas, and children, adolescents and young adults with neurofibromatosis type 1 and previously untreated low-grade gliomas MedDRA version: 20.0;Level: PT;Classification code 10065443;Term: Malignant glioma;System Organ Class: 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps) MedDRA version: 20.0;Classification code 10038111;Term: Recurrent cancer;Classification code 10070308;Term: Refractory cancer;System Organ Class: 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps);Therapeutic area: Diseases [C] - Cancer [C04] | Product Name: Nilotinib Product Code: AMN107 Other descriptive name: NILOTINIB HYDROCHLORIDE MONOHYDRATE Trade Name: Tasigna 150mg Product Name: Nilotinib INN or Proposed INN: NILOTINIB Trade Name: Tasigna 200mg Product Name: Nilotinib INN or Proposed INN: NILOTINIB Product Name: Vinblastine Other descriptive name: VINBLASTINE SULPHATE Trade Name: Tasigna 50 mg Product Name: Nilotinib INN or Proposed INN: NILOTINIB | Gustave Roussy | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | 160 | Phase 2 | France;Spain;Denmark;Netherlands;Switzerland | ||
| 2 | EUCTR2010-023508-28-GB (EUCTR) | 14/04/2011 | 30/11/2010 | A CLINICAL TRIAL OF THE INTRA-TUMOURAL CONCENTRATION AND ACTIVITY OF NILOTINIB IN INTRA-CUTANEOUS SCHWANNOMAS - PHNT NilotinibNF2 | A CLINICAL TRIAL OF THE INTRA-TUMOURAL CONCENTRATION AND ACTIVITY OF NILOTINIB IN INTRA-CUTANEOUS SCHWANNOMAS - PHNT NilotinibNF2 | In vivo investigation of the intra-tumoural concentration and activity of nilotinib in cutaneous schwannomas (CS) in patienst with Neurofibromatosis 2 | Plymouth Hospital NHS Trust | NULL | Not Recruiting | Female: yes Male: yes | 5 | Phase 4 | United Kingdom | |||
| 3 | NCT01275586 (ClinicalTrials.gov) | January 2011 | 11/1/2011 | Study of Tasigna®/Nilotinib (AMN107) in Neurofibromatosis (NF1) Patients With Plexiform Neurofibromas | Pilot Study of Tasigna®/Nilotinib (AMN107) in Neurofibromatosis (NF1) Patients With Plexiform Neurofibromas | Neurofibromatosis;NF1;Neurofibromas | Drug: Tasigna | Indiana University | Novartis | Completed | 18 Years | N/A | All | 6 | Early Phase 1 | United States |
| 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 | NCT01166139 (ClinicalTrials.gov) | July 2010 | 1/7/2010 | Nilotinib in the Treatment of Systemic Sclerosis | Phase IIA Study of the Safety and Tolerability of the Use of Nilotinib in the Treatment of Systemic Sclerosis | Systemic Sclerosis | Drug: Nilotinib (Tasigna) | Hospital for Special Surgery, New York | Rudolph Rupert Scleroderma Program;Novartis Pharmaceuticals | Completed | 18 Years | N/A | All | 10 | Phase 2 | United States |
| 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 | EUCTR2010-019883-36-DE (EUCTR) | 13/10/2011 | 13/05/2011 | A 24 week, randomized, double blind, multicenter, placebo-controlled efficacy, safety, tolerability and PK trial of Nilotinib (AMN107) in Pulmonary Arterial Hypertension (PAH) | A 24 week, randomized, double blind, multicenter, placebo-controlled efficacy, safety, tolerability and PK trial of Nilotinib (AMN107) in Pulmonary Arterial Hypertension (PAH) | Pulmonary Arterial Hypertension (PAH) Class II or III patients remaining symptomatic despite at least one PAH-specific therapy. MedDRA version: 14.1;Level: PT;Classification code 10064911;Term: Pulmonary arterial hypertension;System Organ Class: 10038738 - Respiratory, thoracic and mediastinal disorders | Trade Name: Tasigna® 150 mg Product Name: Tasigna Product Code: AMN107 INN or Proposed INN: nilotinib Product Name: Nilotinib 50 mg Product Code: AMN107 INN or Proposed INN: nilotinib | Novartis Pharma Services AG | NULL | Not Recruiting | Female: yes Male: yes | 55 | United States;Hungary;Canada;Singapore;Germany;Switzerland;Italy;Korea, Republic of | |||
| 2 | EUCTR2010-019883-36-IT (EUCTR) | 20/09/2010 | 24/09/2010 | ND | A 24 week, randomized, double blind, multicenter, placebocontrolled efficacy, safety, tolerability and PK trial of Nilotinib (AMN107) in Pulmonary Arterial Hypertension (PAH) | Pulmonary Arterial Hypertension (PAH) MedDRA version: 14.1;Level: PT;Classification code 10037400;Term: Pulmonary hypertension;System Organ Class: 10038738 - Respiratory, thoracic and mediastinal disorders;Therapeutic area: Diseases [C] - Respiratory Tract Diseases [C08] | Trade Name: TASIGNA INN or Proposed INN: nilotinib Trade Name: TASIGNA INN or Proposed INN: nilotinib Trade Name: TASIGNA INN or Proposed INN: nilotinib | NOVARTIS FARMA | NULL | Not Recruiting | Female: yes Male: yes | 55 | United States;Hungary;Canada;Singapore;Germany;Italy;Korea, Republic of | |||
| 3 | EUCTR2010-019883-36-HU (EUCTR) | 31/08/2010 | 08/07/2010 | A 24 week, randomized, double blind, multicenter, placebo-controlled efficacy, safety, tolerability and PK trial of Nilotinib (Tasigna®, AMN107) in Pulmonary Arterial Hypertension (PAH) | A 24 week, randomized, double blind, multicenter, placebo-controlled efficacy, safety, tolerability and PK trial of Nilotinib (Tasigna®, AMN107) in Pulmonary Arterial Hypertension (PAH) | Pulmonary Arterial Hypertension (PAH) Class II or III patients remaining symptomatic despite at least one PAH-specific therapy. MedDRA version: 12.1;Level: LLT;Classification code 10064911;Term: Pulmonary arterial hypertension | Trade Name: Tasigna® Product Name: Tasigna Product Code: AMN107 INN or Proposed INN: nilotinib Product Name: nilotinib Product Code: AMN107 INN or Proposed INN: nilotinib Product Name: Nilotinib Product Code: AMN107 INN or Proposed INN: nilotinib | Novartis Pharma AG | NULL | Not Recruiting | Female: yes Male: yes | 66 | Hungary;Germany | |||
| 4 | NCT01179737 (ClinicalTrials.gov) | July 2010 | 3/8/2010 | Efficacy, Safety, Tolerability and Pharmacokinetics (PK) of Nilotinib (AMN107) in Pulmonary Arterial Hypertension (PAH) | A 24 Week, Randomized, Double Blind, Multicenter, Placebocontrolled Efficacy, Safety, Tolerability and PK Trial of Nilotinib (Tasigna®, AMN107) in Pulmonary Arterial Hypertension (PAH) | Pulmonary Arterial Hypertension | Drug: Nilotinib;Drug: Placebo to nilotinib | Novartis Pharmaceuticals | NULL | Terminated | 18 Years | N/A | All | 23 | Phase 2 | United States;Canada;Germany;Korea, Republic of;Singapore;Switzerland;Hungary;Italy |