SIGNIFOR ( DrugBank: - )


1 disease
告示番号疾患名(ページ内リンク)臨床試験数
75クッシング病22

75. クッシング病


臨床試験数 : 203 薬物数 : 191 - (DrugBank : 51) / 標的遺伝子数 : 62 - 標的パスウェイ数 : 128
No.TrialIDDate_
enrollment
Date_
registration
Public_titleScientific_titleConditionInterventionPrimary_
sponsor
Secondary_
sponsor
Recruitment_
Status
Inclusion_
agemin
Inclusion_
agemax
Inclusion_
gender
Target_
size
PhaseCountries
1EUCTR2013-000267-84-BG
(EUCTR)
12/12/201718/09/2017Study to roll over patients who have completed a study with pasireotide and benefit from the study treatment.An open label, multicenter pasireotide roll over protocol for patients who have completed a previous Novartis sponsored pasireotide study and are judged by the investigator to benefit from continued pasireotide treatment Cushing's diseaseAcromegaly Carcinoid tumorsRare tumors of neuroendocrine originDumping SyndromeMetastatic melanoma Metastatic Merkel cell carcinoma;Therapeutic area: Diseases [C] - Hormonal diseases [C19]Trade Name: Signifor
Product Name: pasireotide 20mg
Product Code: SOM230
INN or Proposed INN: pasireotide
Trade Name: Signifor
Product Name: pasireotide 40mg
Product Code: SOM230
INN or Proposed INN: pasireotide
Trade Name: Signifor
Product Name: pasireotide 60mg
Product Code: SOM230
INN or Proposed INN: pasireotide
Recordati AGNULLAuthorised-recruitment may be ongoing or finishedFemale: yes
Male: yes
220Phase 4Portugal;United States;Taiwan;Greece;Thailand;Spain;Israel;Russian Federation;Italy;France;Mexico;Canada;Argentina;Poland;Belgium;Brazil;Australia;Bulgaria;Netherlands;China;Korea, Republic of
2EUCTR2013-000267-84-PT
(EUCTR)
24/04/201722/02/2017Study to roll over patients who have completed a study with pasireotide and benefit from the study treatment.An open label, multicenter pasireotide roll over protocol for patients who have completed a previous Novartis sponsored pasireotide study and are judged by the investigator to benefit from continued pasireotide treatment Cushing's diseaseAcromegaly Carcinoid tumorsRare tumors of neuroendocrine originDumping SyndromeMetastatic melanoma Metastatic Merkel cell carcinoma
MedDRA version: 20.0;Level: PT;Classification code 10000599;Term: Acromegaly;System Organ Class: 10014698 - Endocrine disorders
MedDRA version: 21.0;Level: LLT;Classification code 10007271;Term: Carcinoid tumor;System Organ Class: 100000004864
MedDRA version: 21.0;Classification code 10062476;Term: Neuroendocrine tumor;System Organ Class: 100000004864
MedDRA version: 20.0;Classification code 10011651;Term: Cushing's disease;System Organ Class: 10014698 - Endocrine disorders
MedDRA version: 20.0;Classification code 10027481;Term: Metastatic melanoma;System Organ Class: 100000004864
MedDRA version: 20.1;Classification code 10013810;Term: Dumping syndrome;System Organ Class: 10017947 - Gastrointestinal disorders
MedDRA version: 21.1;Classification code 10064025;Term: Merkel cell carcinoma;System Organ Class: 100000004864;Therapeutic area: Diseases [C] - Hormonal diseases [C19]
Trade Name: Signifor
Product Name: pasireotide 20mg
Product Code: SOM230
INN or Proposed INN: pasireotide
Trade Name: Signifor
Product Name: pasireotide 40mg
Product Code: SOM230
INN or Proposed INN: pasireotide
Trade Name: Signifor
Product Name: pasireotide 60mg
Product Code: SOM230
INN or Proposed INN: pasireotide
Recordati AGNULLNot RecruitingFemale: yes
Male: yes
220Phase 4Portugal;United States;Taiwan;Greece;Spain;Thailand;Israel;Russian Federation;Italy;France;Mexico;Canada;Argentina;Poland;Belgium;Brazil;Australia;Bulgaria;Netherlands;China;Korea, Republic of
3EUCTR2013-000267-84-PL
(EUCTR)
05/02/201616/12/2015Study to roll over patients who have completed a study with pasireotide and benefit from the study treatment.An open label, multicenter pasireotide roll over protocol for patients who have completed a previous Novartis sponsored pasireotide study and are judged by the investigator to benefit from continued pasireotide treatment - Roll over protocol with pasireotide Cushing's diseaseAcromegalyNeuroendocrine tumorsPituitary tumorsEctopic ACTH secreting (EAS) tumorsDumping SyndromeProstate cancerMelanoma negative for bRAF
MedDRA version: 21.0;Level: LLT;Classification code 10062476;Term: Neuroendocrine tumor;System Organ Class: 100000004864
MedDRA version: 20.0;Classification code 10011651;Term: Cushing's disease;System Organ Class: 100000004860
MedDRA version: 20.0;Classification code 10000600;Term: Acromegaly and gigantism;System Organ Class: 100000004860;Therapeutic area: Not possible to specify
Trade Name: Signifor
Product Name: pasireotide
Product Code: SOM230
INN or Proposed INN: pasireotide
Other descriptive name: PASIREOTIDE
Trade Name: Signifor
Product Name: pasireotide
Product Code: SOM230
INN or Proposed INN: pasireotide
Other descriptive name: PASIREOTIDE
Trade Name: Signifor
Product Name: pasireotide
Product Code: SOM230
INN or Proposed INN: pasireotide
Other descriptive name: PASIREOTIDE
Trade Name: Signifor
Product Name: pasireotide
Product Code: SOM230
INN or Proposed INN: pasireotide
Other descriptive name: PASIREOTIDE
Trade Name: Signifor
Product Name: pasireotide
Product Code: SOM230
INN or Proposed INN: pasireotide
Other descriptive name: PASIREOTIDE
Trade Name: Signifor
Product Name: pasireotide
Product Code: SOM230
Novartis Pharma Services AGNULLNot RecruitingFemale: yes
Male: yes
100Phase 4Portugal;United States;Taiwan;Greece;Thailand;Spain;Israel;Russian Federation;Italy;France;Mexico;Canada;Argentina;Belgium;Poland;Brazil;Australia;Bulgaria;Netherlands;China;Korea, Republic of
4EUCTR2012-002916-16-PL
(EUCTR)
29/06/201516/03/2015Study of management of pasireotide-induced hyperglycemia in adult patients with Cushing’s disease or acromegalyA multi-center, randomized, open-label, Phase IV study to investigate the management of pasireotide-induced hyperglycemia with incretin based therapy or insulin in adult patients with Cushing’s disease or acromegaly. Cushing's disease and acromegaly
MedDRA version: 19.0;Level: LLT;Classification code 10011651;Term: Cushing's disease;System Organ Class: 100000004860
MedDRA version: 19.0;Classification code 10000600;Term: Acromegaly and gigantism;System Organ Class: 100000004860;Therapeutic area: Diseases [C] - Hormonal diseases [C19]
Trade Name: Signifor
Product Name: pasireotide
Product Code: SOM230
INN or Proposed INN: PASIREOTIDE DIASPARTATE
Trade Name: Signifor
Product Name: pasireotide
Product Code: SOM230
INN or Proposed INN: PASIREOTIDE DIASPARTATE
Trade Name: Signifor
Product Name: pasireotide
Product Code: SOM230
INN or Proposed INN: PASIREOTIDE DIASPARTATE
Trade Name: Signifor
Product Name: pasireotide LAR
Product Code: SOM230 LAR
INN or Proposed INN: pasireotide pamoate
Other descriptive name: PASIREOTIDE PAMOATE
Trade Name: Signifor
Product Name: pasireotide LAR
Product Code: SOM230 LAR
INN or Proposed INN: PASIREOTIDE PAMOATE
Other descriptive name: PASIREOTIDE PAMOATE
Trade Name: Signifor
Product Name: pasireotide LAR
Product Code: SOM230 LAR
INN or Proposed INN: PASIREOTIDE PAMOATE
Other descriptive name: PASIREOTIDE PAMOATE
Novartis Pharma Services AGNULLNot RecruitingFemale: yes
Male: yes
133Phase 4United States;Belgium;Poland;Turkey;Denmark;Russian Federation;Germany;China
5EUCTR2012-002916-16-BE
(EUCTR)
04/05/201531/03/2015Study of management of pasireotide-induced hyperglycemia in adult patients with Cushing’s disease or acromegalyA multi-center, randomized, open-label, Phase IV study to investigate the management of pasireotide-induced hyperglycemia with incretin based therapy or insulin in adult patients with Cushing’s disease or acromegaly. Cushing's disease and acromegaly
MedDRA version: 17.1;Level: LLT;Classification code 10011651;Term: Cushing's disease;System Organ Class: 100000004860
MedDRA version: 17.1;Classification code 10000600;Term: Acromegaly and gigantism;System Organ Class: 100000004860;Therapeutic area: Diseases [C] - Hormonal diseases [C19]
Trade Name: Signifor
Product Name: pasireotide
Product Code: SOM230
INN or Proposed INN: PASIREOTIDE DIASPARTATE
Trade Name: Signifor
Product Name: pasireotide
Product Code: SOM230
INN or Proposed INN: PASIREOTIDE DIASPARTATE
Trade Name: Signifor
Product Name: pasireotide
Product Code: SOM230
INN or Proposed INN: PASIREOTIDE DIASPARTATE
Trade Name: Signifor
Product Name: pasireotide LAR
Product Code: SOM230 LAR
INN or Proposed INN: PASIREOTIDE
Other descriptive name: PASIREOTIDE PAMOATE
Trade Name: Signifor
Product Name: pasireotide LAR
Product Code: SOM230 LAR
INN or Proposed INN: PASIREOTIDE
Other descriptive name: PASIREOTIDE PAMOATE
Trade Name: Signifor
Product Name: pasireotide LAR
Product Code: SOM230 LAR
INN or Proposed INN: PASIREOTIDE
Other descriptive name: PASIREOTIDE PAMOATE
Novartis Pharma Services AGNULLNot RecruitingFemale: yes
Male: yes
132Phase 4United States;Spain;Thailand;Turkey;Russian Federation;India;Poland;Belgium;Brazil;Romania;Denmark;Peru;Bulgaria;Germany;Netherlands;China
6EUCTR2013-002170-49-NL
(EUCTR)
25/03/201517/12/2014A Phase II trial to assess the efficacy and safety of pasireotide s.c. alone or in combination with cabergoline in patients with Cushing’s diseaseA Phase II trial to assess the efficacy and safety of pasireotide s.c. alone or in combination with cabergoline in patients with Cushing’s disease Cushing's disease
MedDRA version: 18.1;Level: LLT;Classification code 10011651;Term: Cushing's disease;System Organ Class: 100000004860 ;Therapeutic area: Diseases [C] - Hormonal diseases [C19]
Trade Name: Signifor
Product Name: pasireotide
Product Code: SOM230
INN or Proposed INN: PASIREOTIDE DIASPARTATE
Trade Name: Signifor
Product Name: pasireotide
Product Code: SOM230
INN or Proposed INN: PASIREOTIDE DIASPARTATE
Trade Name: Signifor
Product Name: pasireotide
Product Code: SOM230
INN or Proposed INN: PASIREOTIDE DIASPARTATE
Trade Name: Dostinex
Product Name: Cabergoline
INN or Proposed INN: cabergoline
Other descriptive name: CABERGOLINE
Novartis Pharma Services AGNULLNot Recruiting Female: yes
Male: yes
64 Human pharmacology (Phase 1): no Therapeutic exploratory (Phase 2): yes Therapeutic confirmatory - (Phase 3): no Therapeutic use (Phase 4): noUnited States;Venezuela, Bolivarian Republic of;Greece;Spain;Turkey;Colombia;Italy;United Kingdom;India;France;Hungary;Mexico;Argentina;Malaysia;Belgium;Brazil;Australia;Bulgaria;Germany;Netherlands
7EUCTR2013-000267-84-ES
(EUCTR)
11/03/201503/03/2015Study to roll over patients who have completed a study with pasireotide and benefit from the study treatment.An open label, multicenter pasireotide roll over protocol for patients who have completed a previous Novartis sponsored pasireotide study and are judged by the investigator to benefit from continued pasireotide treatment - Roll over protocol with pasireotide Cushing's disease Acromegaly Neuroendocrine tumors Pituitary tumors EctopicACTH secreting (EAS) tumors Dumping Syndrome Prostate cancer Melanomanegative for bRAF;Therapeutic area: Diseases [C] - Cancer [C04]Trade Name: Signifor
Product Name: pasireotide
Product Code: SOM230
INN or Proposed INN: pasireotide
Other descriptive name: PASIREOTIDE
Trade Name: Signifor
Product Name: pasireotide
Product Code: SOM230
INN or Proposed INN: pasireotide
Other descriptive name: PASIREOTIDE
Trade Name: Signifor
Product Name: pasireotide
Product Code: SOM230
INN or Proposed INN: pasireotide
Other descriptive name: PASIREOTIDE
Product Name: pasireotide
Product Code: SOM230
INN or Proposed INN: pasireotide
Other descriptive name: PASIREOTIDE
Product Name: pasireotide
Product Code: SOM230
INN or Proposed INN: pasireotide
Other descriptive name: PASIREOTIDE
Product Name: pasireotide
Product Code: SOM230
INN or Proposed INN: pasireotide
Other descriptive name: PASIREOTIDE
Novartis Farmacéutica, S.A.NULLAuthorised-recruitment may be ongoing or finishedFemale: yes
Male: yes
100United States;Taiwan;Greece;Spain;Thailand;Russian Federation;Israel;Italy;Mexico;Canada;Argentina;Belgium;Brazil;Australia;Netherlands;China;Korea, Republic of
8EUCTR2012-002916-16-DE
(EUCTR)
19/08/201417/03/2014 Study of management of pasireotide-induced hyperglycemia in adult patients with Cushing’s disease or acromegaly A multi-center, randomized, open-label, Phase IV study to investigate the management of pasireotide-induced hyperglycemia with incretin based therapy or insulin in adult patients with Cushing’s disease or acromegaly. Cushing's disease and acromegaly
MedDRA version: 19.0;Level: LLT;Classification code 10011651;Term: Cushing's disease;System Organ Class: 100000004860
MedDRA version: 19.0;Classification code 10000600;Term: Acromegaly and gigantism;System Organ Class: 100000004860 ;Therapeutic area: Diseases [C] - Hormonal diseases [C19]
Trade Name: Signifor
Product Name: pasireotide
Product Code: SOM230, 300micrograms
INN or Proposed INN: PASIREOTIDE
Other descriptive name: PASIREOTIDE DIASPARTATE
Trade Name: Signifor
Product Name: pasireotide
Product Code: SOM230, 600 micrograms
INN or Proposed INN: PASIREOTIDE
Other descriptive name: PASIREOTIDE DIASPARTATE
Trade Name: Signifor
Product Name: pasireotide
Product Code: SOM230, 900 micrograms
INN or Proposed INN: PASIREOTIDE
Other descriptive name: PASIREOTIDE DIASPARTATE
Product Name: pasireotide LAR
Product Code: SOM230 LAR, 20 mg
INN or Proposed INN: PASIREOTIDE
Other descriptive name: PASIREOTIDE PAMOATE
Novartis Pharma Services AGNULLNot Recruiting Female: yes
Male: yes
133 Human pharmacology (Phase 1): no Therapeutic exploratory (Phase 2): no Therapeutic confirmatory - (Phase 3): no Therapeutic use (Phase 4): yesUnited States;Belgium;Poland;Turkey;Denmark;Russian Federation;Germany;China
9EUCTR2012-002916-16-DK
(EUCTR)
01/07/201409/04/2014Study of management of pasireotide-induced hyperglycemiain adult patients with Cushing’s disease or acromegalyA multi-center, randomized, open-label, Phase IV study toinvestigate the management of pasireotide-inducedhyperglycemia with incretin based therapy or insulin inadult patients with Cushing’s disease or acromegaly. Cushing's disease and acromegaly
MedDRA version: 19.0;Level: LLT;Classification code 10011651;Term: Cushing's disease;System Organ Class: 100000004860
MedDRA version: 19.0;Classification code 10000600;Term: Acromegaly and gigantism;System Organ Class: 100000004860;Therapeutic area: Diseases [C] - Hormonal diseases [C19]
Trade Name: Signifor
Product Name: pasireotide
Product Code: SOM230
INN or Proposed INN: PASIREOTIDE DIASPARTATE
Trade Name: Signifor
Product Name: pasireotide
Product Code: SOM230
INN or Proposed INN: PASIREOTIDE DIASPARTATE
Other descriptive name: SOM230B
Trade Name: Signifor
Product Name: pasireotide
Product Code: SOM230
INN or Proposed INN: PASIREOTIDE DIASPARTATE
Product Name: pasireotide LAR
Product Code: SOM230 LAR
Other descriptive name: PASIREOTIDE PAMOATE
Product Name: pasireotide LAR
Product Code: SOM230 LAR
Other descriptive name: PASIREOTIDE PAMOATE
Product Name: pasireotide LAR
Product Code: SOM230 LAR
Other descriptive name: PASIREOTIDE PAMOATE
Novartis Pharma Services AGNULLNot RecruitingFemale: yes
Male: yes
133Phase 4United States;Belgium;Poland;Turkey;Denmark;Russian Federation;Germany;China
10EUCTR2013-002170-49-BE
(EUCTR)
19/03/201404/12/2013 A Phase II trial to assess the efficacy and safety of pasireotide s.c. alone or in combination with cabergoline in patients with Cushing's disease A Phase II trial to assess the efficacy and safety of pasireotide s.c. alone or in combination with cabergoline in patients with Cushing’s disease Cushing's disease
MedDRA version: 19.0;Level: LLT;Classification code 10011651;Term: Cushing's disease;System Organ Class: 100000004860
Trade Name: Signifor
Product Name: pasireotide 0.3mg
Product Code: SOM230
INN or Proposed INN: PASIREOTIDE DIASPARTATE
Trade Name: Signifor
Product Name: pasireotide 0.6mg
Product Code: SOM230
INN or Proposed INN: PASIREOTIDE DIASPARTATE
Trade Name: Signifor
Product Name: pasireotide 0.9 mg
Product Code: SOM230
INN or Proposed INN: PASIREOTIDE DIASPARTATE
Trade Name: Dostinex
Product Name: Cabergoline
Other descriptive name: CABERGOLINE
Novartis Pharma Services AGNULLNot Recruiting Female: yes
Male: yes
64 Human pharmacology (Phase 1): no Therapeutic exploratory (Phase 2): yes Therapeutic confirmatory - (Phase 3): no Therapeutic use (Phase 4): noUnited States;Venezuela, Bolivarian Republic of;Greece;Spain;Turkey;Colombia;Italy;United Kingdom;India;France;Hungary;Mexico;Argentina;Malaysia;Belgium;Brazil;Australia;Bulgaria;Netherlands;Germany
11EUCTR2013-002170-49-HU
(EUCTR)
03/02/201413/12/2013A Phase II trial to assess the efficacy and safety of pasireotide s.c. alone or in combination with cabergoline in patients with Cushing’s diseaseA Phase II trial to assess the efficacy and safety of pasireotide s.c. alone or in combination with cabergoline in patients with Cushing’s disease Cushing's disease
MedDRA version: 18.0;Level: LLT;Classification code 10011651;Term: Cushing's disease;System Organ Class: 100000004860;Therapeutic area: Diseases [C] - Hormonal diseases [C19]
Trade Name: Signifor
Product Name: pasireotide
Product Code: SOM230
INN or Proposed INN: PASIREOTIDE DIASPARTATE
Trade Name: Signifor
Product Name: pasireotide
Product Code: SOM230
INN or Proposed INN: PASIREOTIDE DIASPARTATE
Trade Name: Signifor
Product Name: pasireotide
Product Code: SOM230
INN or Proposed INN: PASIREOTIDE DIASPARTATE
Trade Name: Dostinex
Product Name: Cabergoline
Other descriptive name: CABERGOLINE
Novartis Pharma Services AGNULLNot RecruitingFemale: yes
Male: yes
64Phase 2United States;Venezuela, Bolivarian Republic of;Greece;Spain;Turkey;Colombia;Italy;India;France;Hungary;Mexico;Argentina;Malaysia;Belgium;Brazil;Australia;Bulgaria;Netherlands;Germany
12EUCTR2013-002170-49-IT
(EUCTR)
21/01/201422/10/2013Study of the efficacy and safety of pasireotide s.c. +/- cabergoline in patients with Cushing’s diseaseA Phase II trial to assess the efficacy and safety ofpasireotide s.c. alone or in combination with cabergoline inpatients with Cushing’s disease Cushing's disease
MedDRA version: 14.1;Level: PT;Classification code 10011652;Term: Cushing's syndrome;System Organ Class: 10014698 - Endocrine disorders;Therapeutic area: Diseases [C] - Hormonal diseases [C19]
Trade Name: Signifor
Product Name: pasireotide
Product Code: SOM230
INN or Proposed INN: PASIREOTIDE DIASPARTATE
Other descriptive name: NA
Trade Name: Signifor
Product Name: pasireotide
Product Code: SOM230
INN or Proposed INN: PASIREOTIDE DIASPARTATE
Other descriptive name: NA
Trade Name: Signifor
Product Name: pasireotide
Product Code: SOM230
INN or Proposed INN: PASIREOTIDE DIASPARTATE
Other descriptive name: NA
Trade Name: Dostinex
Product Name: Cabergoline
Product Code: NA
INN or Proposed INN: cabergoline
Other descriptive name: NA
NOVARTIS FARMA S.p.A.NULLNot RecruitingFemale: yes
Male: yes
128Phase 2United States;Venezuela, Bolivarian Republic of;Greece;Spain;Turkey;Colombia;United Kingdom;Italy;India;France;Hungary;Mexico;Argentina;Belgium;Brazil;Malaysia;Australia;Bulgaria;Netherlands;Germany
13EUCTR2013-002170-49-ES
(EUCTR)
21/11/201312/11/2013A Phase II trial to assess the efficacy and safety ofpasireotide s.c. alone or in combination with cabergoline in patients with Cushing?s diseaseA Phase II trial to assess the efficacy and safety ofpasireotide s.c. alone or in combination with cabergoline in patients with Cushing?s disease Cushing's disease;Therapeutic area: Diseases [C] - Cancer [C04]Trade Name: SIGNIFOR
Product Name: pasireotide
Product Code: SOM230
INN or Proposed INN: PASIREOTIDE DIASPARTATE
Other descriptive name: PASIREOTIDE DIASPARTATE
Trade Name: SIGNIFOR
Product Name: pasireotide
Product Code: SOM230
INN or Proposed INN: PASIREOTIDE DIASPARTATE
Other descriptive name: PASIREOTIDE DIASPARTATE
Trade Name: SIGNIFOR
Product Name: pasireotide
Product Code: SOM230
INN or Proposed INN: PASIREOTIDE DIASPARTATE
Other descriptive name: PASIREOTIDE DIASPARTATE
Trade Name: Dostinex
Product Name: Cabergoline
INN or Proposed INN: CABERGOLINE
Other descriptive name: CABERGOLINE
Novartis Farmacéutica , S.A.NULLNot RecruitingFemale: yes
Male: yes
128Phase 2United States;Venezuela, Bolivarian Republic of;Greece;Spain;Turkey;Colombia;United Kingdom;Italy;India;France;Hungary;Mexico;Argentina;Malaysia;Belgium;Brazil;Australia;Bulgaria;Netherlands;Germany
14EUCTR2013-002170-49-DE
(EUCTR)
19/11/201317/09/2013A Phase II trial to assess the efficacy and safety of pasireotide s.c. alone or in combination with cabergoline in patients with Cushing's diseaseA Phase II trial to assess the efficacy and safety of pasireotide s.c. alone or in combination with cabergoline in patients with Cushing's disease Cushing's disease
MedDRA version: 19.0;Level: LLT;Classification code 10011651;Term: Cushing's disease;System Organ Class: 100000004860;Therapeutic area: Diseases [C] - Hormonal diseases [C19]
Trade Name: Signifor
Product Name: pasireotide
Product Code: SOM230
INN or Proposed INN: PASIREOTIDE DIASPARTATE
Trade Name: Signifor
Product Name: pasireotide
Product Code: SOM230
INN or Proposed INN: PASIREOTIDE DIASPARTATE
Trade Name: Signifor
Product Name: pasireotide
Product Code: SOM230
INN or Proposed INN: PASIREOTIDE DIASPARTATE
Trade Name: Dostinex
Product Name: Cabergoline
Other descriptive name: CABERGOLINE
Novartis Pharma Services AGNULLNot RecruitingFemale: yes
Male: yes
64Phase 2United States;Venezuela, Bolivarian Republic of;Greece;Spain;Turkey;Colombia;Italy;India;France;Hungary;Mexico;Argentina;Belgium;Brazil;Malaysia;Australia;Bulgaria;Netherlands;Germany
15EUCTR2013-000267-84-FR
(EUCTR)
07/08/201323/09/2015An open label, multicenter pasireotide roll over protocol for patients who have completed a previous Novartis sponsored pasireotide study and are judged by the investigator to benefit from continued pasireotide treatmentAn open label, multicenter pasireotide roll over protocol for patients who have completed a previous Novartis sponsored pasireotide study and are judged by the investigator to benefit from continued pasireotide treatment Cushing’s diseaseAcromegalyNeuroendocrine tumorsPituitary tumorsEctopic ACTH secreting (EAS) tumorsDumping SyndromeProstate cancerMelanoma negative for bRAFTrade Name: Signifor
Product Name: pasireotide
Product Code: SOM230
INN or Proposed INN: pasireotide
Trade Name: Signifor
Product Name: pasireotide
Product Code: SOM230
INN or Proposed INN: pasireotide
Trade Name: Signifor
Product Name: pasireotide
Product Code: SOM230
INN or Proposed INN: pasireotide
Product Name: pasireotide
Product Code: SOM230
INN or Proposed INN: pasireotide
Product Name: pasireotide
Product Code: SOM230
INN or Proposed INN: pasireotide
Product Name: pasireotide
Product Code: SOM230
INN or Proposed INN: pasireotide
Novartis Pharma Services AGNULLAuthorised-recruitment may be ongoing or finishedFemale: yes
Male: yes
100United States;Greece;Spain;Thailand;Russian Federation;Israel;Italy;France;Mexico;Canada;Belgium;Brazil;Australia;Germany;Norway;China
16EUCTR2013-000267-84-IT
(EUCTR)
07/06/201308/04/2013Protocol for patients who have completed a previous Novartis sponsored pasireotide study and are judged by the investigator to benefit from continued pasireotide treatmentAn open label, multicenter pasireotide roll over protocol for patients who have completed a previous Novartis sponsored pasireotide study and are judged by the investigator to benefit from continued pasireotide treatment Cushing’s diseaseNeuroendocrine tumors
MedDRA version: 14.1;Level: LLT;Classification code 10062476;Term: Neuroendocrine tumor;System Organ Class: 100000004864
MedDRA version: 14.1;Level: PT;Classification code 10011652;Term: Cushing's syndrome;System Organ Class: 10014698 - Endocrine disorders;Therapeutic area: Diseases [C] - Cancer [C04]
Trade Name: Signifor
Product Name: pasireotide
Product Code: SOM230
INN or Proposed INN: PASIREOTIDE
Other descriptive name: NA
Product Name: pasireotide
Product Code: SOM230
INN or Proposed INN: PASIREOTIDE
Other descriptive name: pasireotide pamoate
Trade Name: Signifor
Product Name: pasireotide
Product Code: SOM230
INN or Proposed INN: PASIREOTIDE
Other descriptive name: NA
Trade Name: Signifor
Product Name: pasireotide
Product Code: SOM230
INN or Proposed INN: PASIREOTIDE
Other descriptive name: NA
Product Name: pasireotide
Product Code: SOM230
INN or Proposed INN: pasireotide
Other descriptive name: pasireotide pamoate
NOVARTIS FARMANULLAuthorised-recruitment may be ongoing or finishedFemale: yes
Male: yes
100United States;Mexico;Canada;Belgium;Brazil;Thailand;Australia;Israel;Russian Federation;China;Italy
17EUCTR2013-000267-84-BE
(EUCTR)
05/06/201322/04/2013Study to roll over patients who have completed a study with pasireotide and benefit from the study treatment.An open label, multicenter pasireotide roll over protocol for patients who have completed a previous Novartis sponsored pasireotide study and are judged by the investigator to benefit from continued pasireotide treatment Cushing's diseaseAcromegalyCarcinoid tumorsRare tumors of neuroendocrine originDumping SyndromeMetastatic melanomaMetastatic Merkel cell carcinoma;Therapeutic area: Diseases [C] - Hormonal diseases [C19]Trade Name: Signifor
Product Name: pasireotide
Product Code: SOM230
INN or Proposed INN: pasireotide
Other descriptive name: PASIREOTIDE
Trade Name: Signifor
Product Name: pasireotide
Product Code: SOM230
INN or Proposed INN: pasireotide
Other descriptive name: PASIREOTIDE
Trade Name: Signifor
Product Name: pasireotide
Product Code: SOM230
INN or Proposed INN: pasireotide
Other descriptive name: PASIREOTIDE
Trade Name: Signifor
Product Name: pasireotide
Product Code: SOM230
INN or Proposed INN: pasireotide
Other descriptive name: PASIREOTIDE
Trade Name: Signifor
Product Name: pasireotide
Product Code: SOM230
INN or Proposed INN: pasireotide
Other descriptive name: PASIREOTIDE
Trade Name: Signifor
Product Name: pasireotide
Product Code: SOM230
Recordati AGNULLAuthorised-recruitment may be ongoing or finishedFemale: yes
Male: yes
100Phase 4Portugal;United States;Greece;Thailand;Spain;Israel;Russian Federation;Italy;France;Mexico;Canada;Poland;Belgium;Brazil;Australia;Bulgaria;China
18EUCTR2009-011128-70-NL
(EUCTR)
18/11/201110/08/2011A phase 3 studie to evaluate if pasireotide is safe and works in patients with Cushing’s diseaseA randomized, double-blind, multicenter, phase III study to evaluate the efficacy and safety of pasireotide LAR in patients with Cushing’s disease Cushing's disease
MedDRA version: 16.1;Level: LLT;Classification code 10011651;Term: Cushing's disease;System Organ Class: 100000004860;Therapeutic area: Diseases [C] - Hormonal diseases [C19]
Trade Name: Signifor
Product Name: pasireotide
Product Code: SOM230
INN or Proposed INN: pasireotide
Other descriptive name: pasireotide pamoate
Trade Name: Signifor
Product Name: pasireotide
Product Code: SOM230
INN or Proposed INN: pasireotide
Other descriptive name: pasireotide pamoate
Trade Name: Signifor
Product Name: pasireotide
Product Code: SOM230
INN or Proposed INN: pasireotide
Other descriptive name: pasireotide pamoate
Trade Name: Signifor
Product Name: pasireotide
Product Code: SOM230
INN or Proposed INN: pasireotide
Other descriptive name: pasireotide pamoate
Novartis Pharma Services AGNULLNot RecruitingFemale: yes
Male: yes
148Phase 3United States;Thailand;Spain;Turkey;Italy;United Kingdom;Canada;Argentina;Poland;Brazil;Belgium;Netherlands;Germany;China;Japan
19EUCTR2009-011128-70-BE
(EUCTR)
25/10/201107/09/2011A randomized, double-blind, multicenter, phase III study to evaluate the efficacy and safety of pasireotide LAR in patients with Cushing’s diseaseA randomized, double-blind, multicenter, phase III study to evaluate the efficacy and safety of pasireotide LAR in patients with Cushing’s disease Cushing's disease
MedDRA version: 19.1;Level: LLT;Classification code 10011651;Term: Cushing's disease;System Organ Class: 100000004860
Product Name: pasireotide
Product Code: SOM230
INN or Proposed INN: pasireotide
Other descriptive name: pasireotide pamoate
Trade Name: Signifor
Product Name: pasireotide
Product Code: SOM230
INN or Proposed INN: pasireotide
Other descriptive name: pasireotide pamoate
Trade Name: Signifor
Product Name: pasireotide
Product Code: SOM230
INN or Proposed INN: pasireotide
Other descriptive name: pasireotide pamoate
Trade Name: Signifor
Product Name: pasireotide
Product Code: SOM230
INN or Proposed INN: pasireotide
Other descriptive name: pasireotide pamoate
Novartis Pharma Services AGNULLNot RecruitingFemale: yes
Male: yes
162Phase 3United States;Thailand;Spain;Turkey;Italy;United Kingdom;Canada;Argentina;Poland;Belgium;Brazil;Peru;Germany;China;Japan
20EUCTR2009-011128-70-PL
(EUCTR)
12/10/201114/09/2011phase III study to evaluate safety and efficacy of pasireotide LAR in patients with Cushing's diseaseA randomized, double-blind, multicenter, phase III study to evaluate the efficacy and safety of pasireotide LAR in patients with Cushing’s disease - Cushing's disease
MedDRA version: 17.0;Level: LLT;Classification code 10011651;Term: Cushing's disease;System Organ Class: 100000004860;Therapeutic area: Diseases [C] - Cancer [C04]
Trade Name: Signifor
Product Name: pasireotide
Product Code: SOM230
INN or Proposed INN: pasireotide
Other descriptive name: pasireotide pamoate
Trade Name: Signifor
Product Name: pasireotide
Product Code: SOM230
INN or Proposed INN: pasireotide
Other descriptive name: pasireotide pamoate
Trade Name: Signifor
Product Name: pasireotide
Product Code: SOM230
INN or Proposed INN: pasireotide
Other descriptive name: pasireotide pamoate
Trade Name: Signifor
Product Name: pasireotide
Product Code: SOM230
INN or Proposed INN: pasireotide
Other descriptive name: pasireotide pamoate
Novartis Pharma Services AGNULLNot RecruitingFemale: yes
Male: yes
162Phase 3United States;Thailand;Spain;Turkey;Italy;United Kingdom;Canada;Argentina;Belgium;Poland;Brazil;Peru;Germany;China;Japan
21EUCTR2010-024165-44-CZ
(EUCTR)
02/09/201118/07/2011safety and efficacy of pasireotide s.c. in patients with Cushing's disease An open-label, multi-center, expanded access study of pasireotide s.c. in patients with Cushing’s disease (Seascape) - Seascape Cushing’s disease
MedDRA version: 18.1;Level: LLT;Classification code 10011651;Term: Cushing's disease;System Organ Class: 100000004860;Therapeutic area: Diseases [C] - Cancer [C04]
Trade Name: Signifor
Product Code: SOM230
INN or Proposed INN: PASIREOTIDE DIASPARTATE
INN or Proposed INN: PASIREOTIDE DIASPARTATE
INN or Proposed INN: PASIREOTIDE DIASPARTATE
Novartis Pharma Services AGNULLNot RecruitingFemale: yes
Male: yes
200United States;Czech Republic;Greece;Brazil;Thailand;Spain;Romania;Russian Federation;Netherlands;Germany;Korea, Republic of
22EUCTR2010-024165-44-DE
(EUCTR)
05/08/201112/05/2011An open-label, multi-center, expanded access study of pasireotide s.c. in patients with Cushing’s disease (Seascape)An open-label, multi-center, expanded access study of pasireotide s.c. in patients with Cushing’s disease (Seascape) - Seascape Cushing’s disease
MedDRA version: 14.1;Level: LLT;Classification code 10011651;Term: Cushing's disease;System Organ Class: 10014698 - Endocrine disorders;Therapeutic area: Diseases [C] - Cancer [C04]
Trade Name: Signifor
Product Name: Signifor
Product Code: SOM230 300µg
INN or Proposed INN: pasireotide
Trade Name: Signifor
Product Name: Signifor
Product Code: SOM230 600µg
INN or Proposed INN: pasireotide
Trade Name: Signifor
Product Name: Signifor
Product Code: SOM230 900µg
INN or Proposed INN: pasireotide
Novartis Pharma Services AGNULLNot RecruitingFemale: yes
Male: yes
300Phase 3Czech Republic;Greece;Spain;Netherlands;Germany