AMN107 ( DrugBank: - )


2 diseases
IDDisease name (Link within this page)Number of trials
34Neurofibromatosis2
86Pulmonary arterial hypertension4

34. Neurofibromatosis


Clinical trials : 137 Drugs : 213 - (DrugBank : 76) / Drug target genes : 87 - Drug target pathways : 200
No.TrialIDDate_
enrollment
Date_
registration
Public_titleScientific_titleConditionInterventionPrimary_
sponsor
Secondary_
sponsor
Recruitment_
Status
Inclusion_
agemin
Inclusion_
agemax
Inclusion_
gender
Target_
size
PhaseCountries
1EUCTR2012-003005-10-DK
(EUCTR)
06/06/201308/05/2013LOW-GRADE GLIOMAPHASE 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 RoussyNULLNot RecruitingFemale: yes
Male: yes
160Phase 2France;Spain;Denmark;Netherlands;Switzerland
2NCT01275586
(ClinicalTrials.gov)
January 201111/1/2011Study of Tasigna®/Nilotinib (AMN107) in Neurofibromatosis (NF1) Patients With Plexiform NeurofibromasPilot Study of Tasigna®/Nilotinib (AMN107) in Neurofibromatosis (NF1) Patients With Plexiform NeurofibromasNeurofibromatosis;NF1;NeurofibromasDrug: TasignaIndiana UniversityNovartisCompleted18 YearsN/AAll6Early Phase 1United States

86. Pulmonary arterial hypertension


Clinical trials : 1,181 Drugs : 701 - (DrugBank : 126) / Drug target genes : 105 - Drug target pathways : 192
No.TrialIDDate_
enrollment
Date_
registration
Public_titleScientific_titleConditionInterventionPrimary_
sponsor
Secondary_
sponsor
Recruitment_
Status
Inclusion_
agemin
Inclusion_
agemax
Inclusion_
gender
Target_
size
PhaseCountries
1EUCTR2010-019883-36-DE
(EUCTR)
13/10/201113/05/2011A 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 AGNULLNot RecruitingFemale: yes
Male: yes
55United States;Hungary;Korea, Republic of;Italy;Switzerland;Germany;Singapore;Canada
2EUCTR2010-019883-36-IT
(EUCTR)
20/09/201024/09/2010NDA 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 FARMANULLNot RecruitingFemale: yes
Male: yes
55United States;Hungary;Canada;Singapore;Germany;Italy;Korea, Republic of
3EUCTR2010-019883-36-HU
(EUCTR)
31/08/201008/07/2010A 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 AGNULLNot RecruitingFemale: yes
Male: yes
66Hungary;Germany
4NCT01179737
(ClinicalTrials.gov)
July 20103/8/2010Efficacy, 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 HypertensionDrug: Nilotinib;Drug: Placebo to nilotinibNovartis PharmaceuticalsNULLTerminated18 YearsN/AAll23Phase 2United States;Canada;Germany;Korea, Republic of;Singapore;Switzerland;Hungary;Italy