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

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

ClinicalTrials.gov Identifier: NCT01794793

Novartis Reference Number: CSOM230B2412

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All compounds are either investigational or being studied for (a) new use(s). Efficacy and safety have not been established. There is no guarantee that they will become commercially available for the use(s) under investigation. 

Study Description

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.

Condition 
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
Phase 
Phase 4
Overall status 
Active, not recruiting
Enrollment count 
413 participants
Start date 
Jun 10, 2013
Completion date 
Jun 09, 2023
Gender 
All
Age(s)
18 Years and older (Adult, Older Adult)

Interventions

Drug
Pasireotide
Administered subcutaneously in strengths 0.3mg, 0.6mg and 0.9mg. Doses to be taken BID or TID, dependent on parent study guidelines.
Drug
Cabergoline
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.
Drug
Pasireotide
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.

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.

Study Locations

United States
Ximed Research SC - SOM230B2412
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La Jolla, 92037
California
United States
Cedars Sinai Medical Center Cedars Sinai 4
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Los Angeles, 90048
California
United States
Stanford Universtiy Medical Center Stanford Hospital & Clinics
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Stanford, 94304
California
United States
University of Michigan Comprehensive Cancer Center SC-2
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Ann Arbor, 48109
Michigan
United States
Memorial Sloan-Kettering Cancer Center SC
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New York, 10065
New York
United States
Virginia Endocrinology Research SC
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Chesapeake, 23321
Virginia
United States
Swedish Cancer Institute Swedish Cancer Institute (SC)
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Seattle, 98104
Washington
United States
Argentina
Novartis Investigative Site
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Caba, C1405BCH
Buenos Aires
Argentina
Novartis Investigative Site
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Mar del Plata, B7602CBM
Buenos Aires
Argentina
Belgium
Novartis Investigative Site
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Edegem, 2650
Antwerpen
Belgium
Novartis Investigative Site
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Brugge, 8310
-
Belgium
Novartis Investigative Site
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Brussel, 1090
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Belgium
Novartis Investigative Site
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Bruxelles, 1200
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Belgium
Novartis Investigative Site
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Gent, 9000
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Belgium
Novartis Investigative Site
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Leuven, 3000
-
Belgium
Novartis Investigative Site
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Liege, 4000
-
Belgium
Novartis Investigative Site
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Wilrijk, 2610
-
Belgium
Brazil
Novartis Investigative Site
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Fortaleza, 60430 370
CE
Brazil
Novartis Investigative Site
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Curitiba, 80030-110
PR
Brazil
Novartis Investigative Site
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Rio de Janeiro, 21941-913
RJ
Brazil
Novartis Investigative Site
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Porto Alegre, 90560 030
RS
Brazil
Novartis Investigative Site
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Joinville, 89201260
SC
Brazil
Novartis Investigative Site
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Botucatu, 18618-970
SP
Brazil
Novartis Investigative Site
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Sao Paulo, 05403 000
SP
Brazil
Bulgaria
Novartis Investigative Site
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Sofia, 1431
-
Bulgaria
Canada
Novartis Investigative Site
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Halifax, B3H 1V7
Nova Scotia
Canada
Novartis Investigative Site
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London, N6A 4L6
Ontario
Canada
Novartis Investigative Site
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Montreal, H2L 4M1
Quebec
Canada
Novartis Investigative Site
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Montreal, H2W 1T8
Quebec
Canada
China
Novartis Investigative Site
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Beijing, 100730
Beijing
China
Novartis Investigative Site
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Guangzhou, 510000
Guangdong
China
Novartis Investigative Site
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Chengdu, 610041
Sichuan
China
France
Novartis Investigative Site
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Toulouse, 31000
Cedex 9
France
Novartis Investigative Site
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Angers cedex 09, 49933
-
France
Novartis Investigative Site
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Bron Cedex, 69677
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France
Novartis Investigative Site
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Le Kremlin Bicetre, 94275
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France
Novartis Investigative Site
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Lille Cedex, 59037
-
France
Novartis Investigative Site
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Marseille cedex 05, 13385
-
France
Novartis Investigative Site
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Pessac Cedex, 33604
-
France
Novartis Investigative Site
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Pierre Benite Cedex, 69495
-
France
Germany
Novartis Investigative Site
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Berlin, 13353
-
Germany
Novartis Investigative Site
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Hamburg, 20246
-
Germany
Novartis Investigative Site
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Muenchen, 81377
-
Germany
Novartis Investigative Site
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Muenchen, 81667
-
Germany
Novartis Investigative Site
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Tübingen, 72076
-
Germany
Novartis Investigative Site
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Ulm, 89081
-
Germany
Novartis Investigative Site
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Wuerzburg, 97080
-
Germany
Greece
Novartis Investigative Site
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Athens, 115 27
GR
Greece
Hungary
Novartis Investigative Site
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Budapest, 1085
-
Hungary
India
Novartis Investigative Site
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Bangalore, 560054
Karnataka
India
Novartis Investigative Site
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Vellore, 632004
Tamil Nadu
India
Israel
Novartis Investigative Site
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Petach Tikva, 49100
-
Israel
Italy
Novartis Investigative Site
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Ancona, 60126
AN
Italy
Novartis Investigative Site
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Genova, 16132
GE
Italy
Novartis Investigative Site
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Milano, 20149
MI
Italy
Novartis Investigative Site
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Padova, 35128
PD
Italy
Novartis Investigative Site
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Roma, 00168
RM
Italy
Japan
Novartis Investigative Site
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Nagoya, 460-0001
Aichi
Japan
Novartis Investigative Site
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Maebashi city, 371 8511
Gunma
Japan
Novartis Investigative Site
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Kobe-shi, 650-0017
Hyogo
Japan
Novartis Investigative Site
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Nankoku city, 783 8505
Kochi
Japan
Novartis Investigative Site
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Kyoto-city, 612-8555
Kyoto
Japan
Novartis Investigative Site
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Suita city, 565 0871
Osaka
Japan
Korea, Republic of
Novartis Investigative Site
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Seoul, 03722
-
Korea, Republic of
Novartis Investigative Site
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Seoul, 06351
-
Korea, Republic of
Malaysia
Novartis Investigative Site
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Pulau Pinang, 10990
-
Malaysia
Novartis Investigative Site
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Wilayah Persekutuan, 62502
-
Malaysia
Mexico
Novartis Investigative Site
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México, 14269
Distrito Federal
Mexico
Novartis Investigative Site
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Guadalajara, 44130
Jalisco
Mexico
Novartis Investigative Site
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Durango, 34270
-
Mexico
Novartis Investigative Site
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Mexico City, 07760
-
Mexico
Netherlands
Novartis Investigative Site
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Groningen, 9713 GZ
-
Netherlands
Peru
Novartis Investigative Site
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San Isidro, 27
Lima
Peru
Poland
Novartis Investigative Site
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Gdansk, 80 952
-
Poland
Novartis Investigative Site
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Poznan, 60-355
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Poland
Novartis Investigative Site
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Warszawa, 04141
-
Poland
Novartis Investigative Site
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Wroclaw, 50 367
-
Poland
Portugal
Novartis Investigative Site
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Porto, 4200-319
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Portugal
Romania
Novartis Investigative Site
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Bucuresti, 011863
-
Romania
Russian Federation
Novartis Investigative Site
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Barnaul, 656024
-
Russian Federation
Novartis Investigative Site
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Moscow, 123317
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Russian Federation
Novartis Investigative Site
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Saint Petersburg, 197341
-
Russian Federation
Novartis Investigative Site
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Tyumen, 625023
-
Russian Federation
Spain
Novartis Investigative Site
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Alicante, 03010
Comunidad Valenciana
Spain
Novartis Investigative Site
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Barcelona, 08041
-
Spain
Switzerland
Novartis Investigative Site
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Lausanne, 1011
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Switzerland
Novartis Investigative Site
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Zuerich, 8091
-
Switzerland
Taiwan
Novartis Investigative Site
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Taichung, 40705
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Taiwan
Thailand
Novartis Investigative Site
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Bangkok, 10400
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Thailand
Novartis Investigative Site
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Bangkok, 10700
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Thailand
Novartis Investigative Site
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Songkla, 90110
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Thailand
Turkey
Novartis Investigative Site
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Istanbul, 34098
TUR
Turkey
Novartis Investigative Site
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Ankara, 06500
-
Turkey
Novartis Investigative Site
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Antalya, 07070
-
Turkey
Novartis Investigative Site
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Istanbul, 34890
-
Turkey
Novartis Investigative Site
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Izmir, 35340
-
Turkey
Novartis Investigative Site
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Kocaeli, 41380
-
Turkey

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