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Study to Allow Access to Pasireotide for Patients Benefiting From Pasireotide Treatment in Novartis-sponsored Studies

Primary Purpose

Cushing's Disease, Acromegaly, Neuroendocrine Tumors

Status
Active
Phase
Phase 4
Locations
International
Study Type
Interventional
Intervention
Pasireotide
Cabergoline
Pasireotide
Sponsored by
RECORDATI GROUP
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Cushing's Disease focused on measuring SOM230,, roll-over study, pasireotide LAR, Cushing's disease, Acromegaly, neuroendocrine tumorsNETs, pituitary tumors, Ectopic ACTH secreting, EAS, Dumping Syndrome, metastatic prostate cancer, metastatic melanoma, bRAF, nRAS

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  1. Patient is currently participating in a Novartis-sponsored study receiving pasireotide (LAR and/or s.c.) on monotherapy or combination therapy (for Cushing's Disease or Acromegaly), and has fulfilled all required assessments in the parent study and patients that are benefiting from the study treatment have no other alternatives.
  2. Patient is currently benefiting from the treatment with pasireotide, as determined by the investigator
  3. Patient has demonstrated compliance, as assessed by the investigator, with the parent study requirements.
  4. Willingness and ability to comply with scheduled visits, treatment plans and any other study procedures.
  5. Written informed consent obtained prior to enrolling in roll-over study and receiving study medication.

    • If consent cannot be expressed in writing, it must be formally documented and witnessed, ideally via an independent trusted witness.

Exclusion Criteria:

  1. Patient has been permanently discontinued from pasireotide study treatment in the parent study due to unacceptable toxicity, non-compliance to study procedures, withdrawal of consent or any other reason.
  2. Pregnant or nursing (lactating) women, where pregnancy is defined as the state of a female after conception and until the termination of gestation, confirmed by a positive hCG laboratory test.
  3. Women of child-bearing potential, defined as all women physiologically capable of becoming pregnant, unless they are using highly effective methods of contraception during the study treatment and for 30 days after the final dose of pasireotide s.c. and 84 days after the final dose of pasireotide LAR. Highly effective contraception is defined as either:

    • Total abstinence (when this is in line with the preferred and usual lifestyle of the patient. Periodic abstinence (e.g., calendar, ovulation, symptothermal, post-ovulation methods) and withdrawal are not acceptable methods of contraception
    • Female sterilization (have had surgical bilateral oophorectomy with or without hysterectomy) or tubal ligation at least six weeks before taking study treatment. In case of oophorectomy alone, only when the reproductive status of the woman has been confirmed by follow up hormone level assessment.
    • Male sterilization (at least 6 months prior to enrolling). For female patients on the study the vasectomized male partner should be the sole partner for that patient.
    • Use of oral, injected or implanted hormonal methods of contraception or placement of an intrauterine device (IUD) or intrauterine system (IUS), or other forms of hormonal contraception that have comparable efficacy (failure rate <1%), for example hormone vaginal ring or transdermal hormone contraception.
    • In case of use of oral contraception women should have been stable on the same pill for a minimum of 3 months before taking study treatment.
    • Women are considered post-menopausal and not of child bearing potential if they have had 12 months of natural (spontaneous) amenorrhea with an appropriate clinical profile (i.e. age appropriate, history of vasomotor symptoms) or have had surgical bilateral oophorectomy (with or without hysterectomy), total hysterectomy, or tubal ligation at least six weeks ago. In the case of oophorectomy alone, only when the reproductive status of the woman has been confirmed by follow up hormone level assessment is she considered not of child-bearing potential.
    • Sexually active males, unless they use a condom during intercourse while taking drug and for 1 months after pasireotide s.c. last dose and 3 months after pasireotide LAR last dose, should not father a child in this period. A condom is required to be used also by vasectomized men in order to prevent delivery of the drug via seminal fluid.

Sites / Locations

  • Ximed Research SC - SOM230B2412
  • Cedars Sinai Medical Center Cedars Sinai 4
  • Stanford Universtiy Medical Center Stanford Hospital & Clinics
  • University of Michigan Comprehensive Cancer Center SC-2
  • Memorial Sloan-Kettering Cancer Center SC
  • Virginia Endocrinology Research SC
  • Swedish Cancer Institute Swedish Cancer Institute (SC)
  • Recordati Investigative Site
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Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Experimental

Arm Label

Pasireotide subcutaneous

Pasireotide Long Acting Release (LAR)

Arm Description

0.3mg, 0.6mg and 0.9mg. Doses to be taken BID or TID, dependent on parent study guidelines. Cabergoline may be combined in this arm for Cushing's Disease and Acromegaly patients.

10mg, 20mg, 40mg and 60mg. All doses to be taken q28days. Strength is dependent on parent study guidelines.

Outcomes

Primary Outcome Measures

Incidence of adverse events to evaluate long term safety data
Collect long term safety data, i.e. SAEs and AEs. SAES will be reviewed and reported as part of the regular pharmacovigilance activities.

Secondary Outcome Measures

Percentage of patients with clinical benefit as assessed by the investigator
Clinical benefit rate as defined by Investigator based on the patients 24 hour Urinary Free Cortisol results.

Full Information

First Posted
February 15, 2013
Last Updated
May 19, 2022
Sponsor
RECORDATI GROUP
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1. Study Identification

Unique Protocol Identification Number
NCT01794793
Brief Title
Study to Allow Access to Pasireotide for Patients Benefiting From Pasireotide Treatment in Novartis-sponsored Studies
Official Title
An Open Label, Multi-center 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
Study Type
Interventional

2. Study Status

Record Verification Date
May 2022
Overall Recruitment Status
Active, not recruiting
Study Start Date
June 10, 2013 (Actual)
Primary Completion Date
June 9, 2023 (Anticipated)
Study Completion Date
June 9, 2023 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
RECORDATI GROUP

4. Oversight

Studies a U.S. FDA-regulated Drug Product
Yes
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

Brief Summary
The purpose of this study is to allow continued use of pasireotide in patients who are on pasireotide treatment in a Novartis-sponsored study and are benefiting from the treatment as judged by the investigator.
Detailed Description
This is a multi-center, open label, phase IV study to provide continued supply of pasireotide to patients being treated in a current Novartis-sponsored study and who are benefiting from treatment with pasireotide alone or in combination with another treatment for Cushing's Disease and Acromegaly . Eligible patients are to be consented and can then continue treatment with pasireotide alone or in combination with another treatment for Cushing's Disease and Acromegaly in this protocol. All patients at their scheduled visits will have drug dispensing information and reported adverse events and serious adverse events collected. A patient will reach the end of study when pasireotide treatment is permanently discontinued and the end of treatment visit has been performed. All patients must be followed up for safety evaluations for 3 months following the last dose of pasireotide LAR treatment and for 1 month following the last dose of pasireotide s.c. treatment. The study is expected to remain open for approximately 10 years or until such time that enrolled patients no longer need treatment with pasireotide or are able to obtain commercial supply according to local regulations for their medical condition.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Cushing's Disease, Acromegaly, Neuroendocrine Tumors, Pituitary Tumors, Ectopic ACTH Secreting (EAS) Tumors, Dumping Syndrome, Prostate Cancer, Melanoma Negative for bRAF, Melanoma Negative for nRAS
Keywords
SOM230,, roll-over study, pasireotide LAR, Cushing's disease, Acromegaly, neuroendocrine tumorsNETs, pituitary tumors, Ectopic ACTH secreting, EAS, Dumping Syndrome, metastatic prostate cancer, metastatic melanoma, bRAF, nRAS

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 4
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
Non-Randomized
Enrollment
413 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Pasireotide subcutaneous
Arm Type
Experimental
Arm Description
0.3mg, 0.6mg and 0.9mg. Doses to be taken BID or TID, dependent on parent study guidelines. Cabergoline may be combined in this arm for Cushing's Disease and Acromegaly patients.
Arm Title
Pasireotide Long Acting Release (LAR)
Arm Type
Experimental
Arm Description
10mg, 20mg, 40mg and 60mg. All doses to be taken q28days. Strength is dependent on parent study guidelines.
Intervention Type
Drug
Intervention Name(s)
Pasireotide
Other Intervention Name(s)
SOM230; Signifor
Intervention Description
Administered subcutaneously in strengths 0.3mg, 0.6mg and 0.9mg. Doses to be taken BID or TID, dependent on parent study guidelines.
Intervention Type
Drug
Intervention Name(s)
Cabergoline
Other Intervention Name(s)
dostinex
Intervention Description
Cabergoline tablet 0.5mg or 1.0mg taken by mouth once daily may be combined with subcutaneous formulation of pasireotide for Cushing's Disease or Acromegaly. Dose is dependent on parent study guidelines.
Intervention Type
Drug
Intervention Name(s)
Pasireotide
Other Intervention Name(s)
SOM230; Signifor
Intervention Description
Long Acting Release is administered by monthly injection. The strengths are 10mg, 20mg, 40mg and 60mg. All doses to be taken q28days. Strength is dependent on parent study guidelines.
Primary Outcome Measure Information:
Title
Incidence of adverse events to evaluate long term safety data
Description
Collect long term safety data, i.e. SAEs and AEs. SAES will be reviewed and reported as part of the regular pharmacovigilance activities.
Time Frame
Baseline up to approximately 10 years
Secondary Outcome Measure Information:
Title
Percentage of patients with clinical benefit as assessed by the investigator
Description
Clinical benefit rate as defined by Investigator based on the patients 24 hour Urinary Free Cortisol results.
Time Frame
Baseline up to approximately 10 years

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Patient is currently participating in a Novartis-sponsored study receiving pasireotide (LAR and/or s.c.) on monotherapy or combination therapy (for Cushing's Disease or Acromegaly), and has fulfilled all required assessments in the parent study and patients that are benefiting from the study treatment have no other alternatives. Patient is currently benefiting from the treatment with pasireotide, as determined by the investigator Patient has demonstrated compliance, as assessed by the investigator, with the parent study requirements. Willingness and ability to comply with scheduled visits, treatment plans and any other study procedures. Written informed consent obtained prior to enrolling in roll-over study and receiving study medication. If consent cannot be expressed in writing, it must be formally documented and witnessed, ideally via an independent trusted witness. Exclusion Criteria: Patient has been permanently discontinued from pasireotide study treatment in the parent study due to unacceptable toxicity, non-compliance to study procedures, withdrawal of consent or any other reason. Pregnant or nursing (lactating) women, where pregnancy is defined as the state of a female after conception and until the termination of gestation, confirmed by a positive hCG laboratory test. Women of child-bearing potential, defined as all women physiologically capable of becoming pregnant, unless they are using highly effective methods of contraception during the study treatment and for 30 days after the final dose of pasireotide s.c. and 84 days after the final dose of pasireotide LAR. Highly effective contraception is defined as either: Total abstinence (when this is in line with the preferred and usual lifestyle of the patient. Periodic abstinence (e.g., calendar, ovulation, symptothermal, post-ovulation methods) and withdrawal are not acceptable methods of contraception Female sterilization (have had surgical bilateral oophorectomy with or without hysterectomy) or tubal ligation at least six weeks before taking study treatment. In case of oophorectomy alone, only when the reproductive status of the woman has been confirmed by follow up hormone level assessment. Male sterilization (at least 6 months prior to enrolling). For female patients on the study the vasectomized male partner should be the sole partner for that patient. Use of oral, injected or implanted hormonal methods of contraception or placement of an intrauterine device (IUD) or intrauterine system (IUS), or other forms of hormonal contraception that have comparable efficacy (failure rate <1%), for example hormone vaginal ring or transdermal hormone contraception. In case of use of oral contraception women should have been stable on the same pill for a minimum of 3 months before taking study treatment. Women are considered post-menopausal and not of child bearing potential if they have had 12 months of natural (spontaneous) amenorrhea with an appropriate clinical profile (i.e. age appropriate, history of vasomotor symptoms) or have had surgical bilateral oophorectomy (with or without hysterectomy), total hysterectomy, or tubal ligation at least six weeks ago. In the case of oophorectomy alone, only when the reproductive status of the woman has been confirmed by follow up hormone level assessment is she considered not of child-bearing potential. Sexually active males, unless they use a condom during intercourse while taking drug and for 1 months after pasireotide s.c. last dose and 3 months after pasireotide LAR last dose, should not father a child in this period. A condom is required to be used also by vasectomized men in order to prevent delivery of the drug via seminal fluid.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Recordati
Organizational Affiliation
Recordati AG
Official's Role
Study Director
Facility Information:
Facility Name
Ximed Research SC - SOM230B2412
City
La Jolla
State/Province
California
ZIP/Postal Code
92037
Country
United States
Facility Name
Cedars Sinai Medical Center Cedars Sinai 4
City
Los Angeles
State/Province
California
ZIP/Postal Code
90048
Country
United States
Facility Name
Stanford Universtiy Medical Center Stanford Hospital & Clinics
City
Stanford
State/Province
California
ZIP/Postal Code
94304
Country
United States
Facility Name
University of Michigan Comprehensive Cancer Center SC-2
City
Ann Arbor
State/Province
Michigan
ZIP/Postal Code
48109
Country
United States
Facility Name
Memorial Sloan-Kettering Cancer Center SC
City
New York
State/Province
New York
ZIP/Postal Code
10065
Country
United States
Facility Name
Virginia Endocrinology Research SC
City
Chesapeake
State/Province
Virginia
ZIP/Postal Code
23321
Country
United States
Facility Name
Swedish Cancer Institute Swedish Cancer Institute (SC)
City
Seattle
State/Province
Washington
ZIP/Postal Code
98104
Country
United States
Facility Name
Recordati Investigative Site
City
Caba
State/Province
Buenos Aires
ZIP/Postal Code
C1405BCH
Country
Argentina
Facility Name
Recordati Investigative Site
City
Mar del Plata
State/Province
Buenos Aires
ZIP/Postal Code
B7602CBM
Country
Argentina
Facility Name
Recordati Investigative Site
City
Edegem
State/Province
Antwerpen
ZIP/Postal Code
2650
Country
Belgium
Facility Name
Recordati Investigative Site
City
Brugge
ZIP/Postal Code
8310
Country
Belgium
Facility Name
Recordati Investigative Site
City
Brussel
ZIP/Postal Code
1090
Country
Belgium
Facility Name
Recordati Investigative Site
City
Bruxelles
ZIP/Postal Code
1200
Country
Belgium
Facility Name
Recordati Investigative Site
City
Gent
ZIP/Postal Code
9000
Country
Belgium
Facility Name
Recordati Investigative Site
City
Leuven
ZIP/Postal Code
3000
Country
Belgium
Facility Name
Recordati Investigative Site
City
Liege
ZIP/Postal Code
4000
Country
Belgium
Facility Name
Recordati Investigative Site
City
Wilrijk
ZIP/Postal Code
2610
Country
Belgium
Facility Name
Recordati Investigative Site
City
Fortaleza
State/Province
CE
ZIP/Postal Code
60430 370
Country
Brazil
Facility Name
Recordati Investigative Site
City
Curitiba
State/Province
PR
ZIP/Postal Code
80030-110
Country
Brazil
Facility Name
Recordati Investigative Site
City
Rio de Janeiro
State/Province
RJ
ZIP/Postal Code
21941-913
Country
Brazil
Facility Name
Recordati Investigative Site
City
Porto Alegre
State/Province
RS
ZIP/Postal Code
90560 030
Country
Brazil
Facility Name
Recordati Investigative Site
City
Joinville
State/Province
SC
ZIP/Postal Code
89201260
Country
Brazil
Facility Name
Recordati Investigative Site
City
Botucatu
State/Province
SP
ZIP/Postal Code
18618-970
Country
Brazil
Facility Name
Recordati Investigative Site
City
Sao Paulo
State/Province
SP
ZIP/Postal Code
05403 000
Country
Brazil
Facility Name
Recordati Investigative Site
City
Sofia
ZIP/Postal Code
1431
Country
Bulgaria
Facility Name
Recordati Investigative Site
City
Halifax
State/Province
Nova Scotia
ZIP/Postal Code
B3H 1V7
Country
Canada
Facility Name
Recordati Investigative Site
City
London
State/Province
Ontario
ZIP/Postal Code
N6A 4L6
Country
Canada
Facility Name
Recordati Investigative Site
City
Montreal
State/Province
Quebec
ZIP/Postal Code
H2L 4M1
Country
Canada
Facility Name
Recordati Investigative Site
City
Montreal
State/Province
Quebec
ZIP/Postal Code
H2W 1T8
Country
Canada
Facility Name
Recordati Investigative Site
City
Toulouse
State/Province
Cedex 9
ZIP/Postal Code
31000
Country
France
Facility Name
Recordati Investigative Site
City
Angers cedex 09
ZIP/Postal Code
49933
Country
France
Facility Name
Recordati Investigative Site
City
Bron Cedex
ZIP/Postal Code
69677
Country
France
Facility Name
Recordati Investigative Site
City
Le Kremlin Bicetre
ZIP/Postal Code
94275
Country
France
Facility Name
Recordati Investigative Site
City
Lille Cedex
ZIP/Postal Code
59037
Country
France
Facility Name
Recordati Investigative Site
City
Marseille cedex 05
ZIP/Postal Code
13385
Country
France
Facility Name
Recordati Investigative Site
City
Pessac Cedex
ZIP/Postal Code
33604
Country
France
Facility Name
Recordati Investigative Site
City
Pierre Benite Cedex
ZIP/Postal Code
69495
Country
France
Facility Name
Recordati Investigative Site
City
Berlin
ZIP/Postal Code
13353
Country
Germany
Facility Name
Recordati Investigative Site
City
Hamburg
ZIP/Postal Code
20246
Country
Germany
Facility Name
Recordati Investigative Site
City
Muenchen
ZIP/Postal Code
81377
Country
Germany
Facility Name
Recordati Investigative Site
City
Muenchen
ZIP/Postal Code
81667
Country
Germany
Facility Name
Recordati Investigative Site
City
Tübingen
ZIP/Postal Code
72076
Country
Germany
Facility Name
Recordati Investigative Site
City
Ulm
ZIP/Postal Code
89081
Country
Germany
Facility Name
Recordati Investigative Site
City
Wuerzburg
ZIP/Postal Code
97080
Country
Germany
Facility Name
Recordati Investigative Site
City
Athens
State/Province
GR
ZIP/Postal Code
115 27
Country
Greece
Facility Name
Recordati Investigative Site
City
Budapest
ZIP/Postal Code
1085
Country
Hungary
Facility Name
Recordati Investigative Site
City
Bangalore
State/Province
Karnataka
ZIP/Postal Code
560054
Country
India
Facility Name
Recordati Investigative Site
City
Vellore
State/Province
Tamil Nadu
ZIP/Postal Code
632004
Country
India
Facility Name
Recordati Investigative Site
City
Petach Tikva
ZIP/Postal Code
49100
Country
Israel
Facility Name
Recordati Investigative Site
City
Ancona
State/Province
AN
ZIP/Postal Code
60126
Country
Italy
Facility Name
Recordati Investigative Site
City
Genova
State/Province
GE
ZIP/Postal Code
16132
Country
Italy
Facility Name
Milano Investigative Site
City
Milano
State/Province
MI
ZIP/Postal Code
20149
Country
Italy
Facility Name
Recordati Investigative Site
City
Padova
State/Province
PD
ZIP/Postal Code
35128
Country
Italy
Facility Name
Recordati Investigative Site
City
Roma
State/Province
RM
ZIP/Postal Code
00168
Country
Italy
Facility Name
Recordati Investigative Site
City
Nagoya
State/Province
Aichi
ZIP/Postal Code
460-0001
Country
Japan
Facility Name
Recordati Investigative Site
City
Maebashi city
State/Province
Gunma
ZIP/Postal Code
371 8511
Country
Japan
Facility Name
Recordati Investigative Site
City
Kobe-shi
State/Province
Hyogo
ZIP/Postal Code
650-0017
Country
Japan
Facility Name
Recordati Investigative Site
City
Nankoku city
State/Province
Kochi
ZIP/Postal Code
783 8505
Country
Japan
Facility Name
Recordati Investigative Site
City
Kyoto-city
State/Province
Kyoto
ZIP/Postal Code
612-8555
Country
Japan
Facility Name
Recordati Investigative Site
City
Suita city
State/Province
Osaka
ZIP/Postal Code
565 0871
Country
Japan
Facility Name
Recordati Investigative Site
City
Seoul
ZIP/Postal Code
03722
Country
Korea, Republic of
Facility Name
Recordati Investigative Site
City
Seoul
ZIP/Postal Code
06351
Country
Korea, Republic of
Facility Name
Recordati Investigative Site
City
Kuala Lumpur
ZIP/Postal Code
62502
Country
Malaysia
Facility Name
Recordati Investigative Site
City
Pulau Pinang
ZIP/Postal Code
10990
Country
Malaysia
Facility Name
Recordati Investigative Site
City
México
State/Province
Distrito Federal
ZIP/Postal Code
14269
Country
Mexico
Facility Name
Recordati Investigative Site
City
Guadalajara
State/Province
Jalisco
ZIP/Postal Code
44130
Country
Mexico
Facility Name
Recordati Investigative Site
City
Durango
ZIP/Postal Code
34270
Country
Mexico
Facility Name
Recordati Investigative Site
City
Mexico City
ZIP/Postal Code
07760
Country
Mexico
Facility Name
Recordati Investigative Site
City
Groningen
ZIP/Postal Code
9713 GZ
Country
Netherlands
Facility Name
Recordati Investigative Site
City
San Isidro
State/Province
Lima
ZIP/Postal Code
27
Country
Peru
Facility Name
Recordati Investigative Site
City
Gdansk
ZIP/Postal Code
80 952
Country
Poland
Facility Name
Recordati Investigative Site
City
Poznan
ZIP/Postal Code
60-355
Country
Poland
Facility Name
Recordati Investigative Site
City
Warszawa
ZIP/Postal Code
04141
Country
Poland
Facility Name
Recordati Investigative Site
City
Wroclaw
ZIP/Postal Code
50 367
Country
Poland
Facility Name
Recordati Investigative Site
City
Porto
ZIP/Postal Code
4200-319
Country
Portugal
Facility Name
Recordati Investigative Site
City
Bucuresti
ZIP/Postal Code
011863
Country
Romania
Facility Name
Recordati Investigative Site
City
Barnaul
ZIP/Postal Code
656024
Country
Russian Federation
Facility Name
Recordati Investigative Site
City
Moscow
ZIP/Postal Code
123317
Country
Russian Federation
Facility Name
Recordati Investigative Site
City
Saint Petersburg
ZIP/Postal Code
197341
Country
Russian Federation
Facility Name
Recordati Investigative Site
City
Tyumen
ZIP/Postal Code
625023
Country
Russian Federation
Facility Name
Recordati Investigative Site
City
Alicante
State/Province
Comunidad Valenciana
ZIP/Postal Code
03010
Country
Spain
Facility Name
Recordati Investigative Site
City
Barcelona
ZIP/Postal Code
08041
Country
Spain
Facility Name
Recordati Investigative Site
City
Lausanne
ZIP/Postal Code
1011
Country
Switzerland
Facility Name
Recordati Investigative Site
City
Zuerich
ZIP/Postal Code
8091
Country
Switzerland
Facility Name
Recordati Investigative Site
City
Taichung
ZIP/Postal Code
40705
Country
Taiwan
Facility Name
Recordati Investigative Site
City
Bangkok
ZIP/Postal Code
10400
Country
Thailand
Facility Name
Recordati Investigative Site
City
Bangkok
ZIP/Postal Code
10700
Country
Thailand
Facility Name
Recordati Investigative Site
City
Songkla
ZIP/Postal Code
90110
Country
Thailand
Facility Name
Recordati Investigative Site
City
Istanbul
State/Province
TUR
ZIP/Postal Code
34098
Country
Turkey
Facility Name
Recordati Investigative Site
City
Ankara
ZIP/Postal Code
06500
Country
Turkey
Facility Name
Recordati Investigative Site
City
Antalya
ZIP/Postal Code
07070
Country
Turkey
Facility Name
Recordati Investigative Site
City
Istanbul
ZIP/Postal Code
34890
Country
Turkey
Facility Name
Recordati Investigative Site
City
Izmir
ZIP/Postal Code
35340
Country
Turkey
Facility Name
Recordati Investigative Site
City
Kocaeli
ZIP/Postal Code
41380
Country
Turkey

12. IPD Sharing Statement

Learn more about this trial

Study to Allow Access to Pasireotide for Patients Benefiting From Pasireotide Treatment in Novartis-sponsored Studies

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