Clinical trial NCT01794793: 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
Overall status: COMPLETED
Phase: PHASE4
Conditions: 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
Lead sponsor: RECORDATI GROUP
Sponsor class: INDUSTRY
First posted: 2013-02-20
Enrollment: 337
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

Eligibility criteria: 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.

Primary outcomes:
measure: Incidence of Adverse Events to Evaluate Long Term Safety Data
timeFrame: Baseline up to approximately 10 years
Secondary outcomes:
measure: Percentage of Patients With Clinical Benefit as Assessed by the Investigator
timeFrame: Baseline up to approximately 10 years
Other outcomes:
Locations:
city: La Jolla
country: United States
facility: Ximed Research SC - SOM230B2412
state: California
city: Los Angeles
country: United States
facility: Cedars Sinai Medical Center Cedars Sinai 4
state: California
city: Stanford
country: United States
facility: Stanford Universtiy Medical Center Stanford Hospital & Clinics
state: California
city: Ann Arbor
country: United States
facility: University of Michigan Comprehensive Cancer Center SC-2
state: Michigan
city: New York
country: United States
facility: Memorial Sloan-Kettering Cancer Center SC
state: New York
city: Chesapeake
country: United States
facility: Virginia Endocrinology Research SC
state: Virginia
city: Seattle
country: United States
facility: Swedish Cancer Institute Swedish Cancer Institute (SC)
state: Washington
city: Caba
country: Argentina
facility: Recordati Investigative Site
state: Buenos Aires
city: Mar del Plata
country: Argentina
facility: Recordati Investigative Site
state: Buenos Aires
city: Edegem
country: Belgium
facility: Recordati Investigative Site
state: Antwerpen
city: Brugge
country: Belgium
facility: Recordati Investigative Site
city: Brussel
country: Belgium
facility: Recordati Investigative Site
city: Bruxelles
country: Belgium
facility: Recordati Investigative Site
city: Gent
country: Belgium
facility: Recordati Investigative Site
city: Leuven
country: Belgium
facility: Recordati Investigative Site
city: Liege
country: Belgium
facility: Recordati Investigative Site
city: Wilrijk
country: Belgium
facility: Recordati Investigative Site
city: Fortaleza
country: Brazil
facility: Recordati Investigative Site
state: CE
city: Curitiba
country: Brazil
facility: Recordati Investigative Site
state: PR
city: Rio de Janeiro
country: Brazil
facility: Recordati Investigative Site
state: RJ
city: Porto Alegre
country: Brazil
facility: Recordati Investigative Site
state: RS
city: Joinville
country: Brazil
facility: Recordati Investigative Site
state: SC
city: Botucatu
country: Brazil
facility: Recordati Investigative Site
state: SP
city: Sao Paulo
country: Brazil
facility: Recordati Investigative Site
state: SP
city: Sofia
country: Bulgaria
facility: Recordati Investigative Site
city: Halifax
country: Canada
facility: Recordati Investigative Site
state: Nova Scotia
city: London
country: Canada
facility: Recordati Investigative Site
state: Ontario
city: Montreal
country: Canada
facility: Recordati Investigative Site
state: Quebec
city: Montreal
country: Canada
facility: Recordati Investigative Site
state: Quebec
city: Toulouse
country: France
facility: Recordati Investigative Site
state: Cedex 9
city: Angers cedex 09
country: France
facility: Recordati Investigative Site
city: Bron Cedex
country: France
facility: Recordati Investigative Site
city: Le Kremlin Bicetre
country: France
facility: Recordati Investigative Site
city: Lille Cedex
country: France
facility: Recordati Investigative Site
city: Marseille cedex 05
country: France
facility: Recordati Investigative Site
city: Pessac Cedex
country: France
facility: Recordati Investigative Site
city: Pierre Benite Cedex
country: France
facility: Recordati Investigative Site
city: Berlin
country: Germany
facility: Recordati Investigative Site
city: Hamburg
country: Germany
facility: Recordati Investigative Site
city: Muenchen
country: Germany
facility: Recordati Investigative Site
city: Muenchen
country: Germany
facility: Recordati Investigative Site
city: Tübingen
country: Germany
facility: Recordati Investigative Site
city: Ulm
country: Germany
facility: Recordati Investigative Site
city: Wuerzburg
country: Germany
facility: Recordati Investigative Site
city: Athens
country: Greece
facility: Recordati Investigative Site
state: GR
city: Budapest
country: Hungary
facility: Recordati Investigative Site
city: Bangalore
country: India
facility: Recordati Investigative Site
state: Karnataka
city: Vellore
country: India
facility: Recordati Investigative Site
state: Tamil Nadu
city: Petach Tikva
country: Israel
facility: Recordati Investigative Site
city: Ancona
country: Italy
facility: Recordati Investigative Site
state: AN
city: Genova
country: Italy
facility: Recordati Investigative Site
state: GE
city: Milano
country: Italy
facility: Milano Investigative Site
state: MI
city: Padova
country: Italy
facility: Recordati Investigative Site
state: PD
city: Roma
country: Italy
facility: Recordati Investigative Site
state: RM
city: Nagoya
country: Japan
facility: Recordati Investigative Site
state: Aichi
city: Maebashi city
country: Japan
facility: Recordati Investigative Site
state: Gunma
city: Kobe-shi
country: Japan
facility: Recordati Investigative Site
state: Hyogo
city: Nankoku city
country: Japan
facility: Recordati Investigative Site
state: Kochi
city: Kyoto-city
country: Japan
facility: Recordati Investigative Site
state: Kyoto
city: Suita city
country: Japan
facility: Recordati Investigative Site
state: Osaka
city: Seoul
country: Korea, Republic of
facility: Recordati Investigative Site
city: Seoul
country: Korea, Republic of
facility: Recordati Investigative Site
city: Kuala Lumpur
country: Malaysia
facility: Recordati Investigative Site
city: Pulau Pinang
country: Malaysia
facility: Recordati Investigative Site
city: México
country: Mexico
facility: Recordati Investigative Site
state: Distrito Federal
city: Guadalajara
country: Mexico
facility: Recordati Investigative Site
state: Jalisco
city: Durango
country: Mexico
facility: Recordati Investigative Site
city: Mexico City
country: Mexico
facility: Recordati Investigative Site
city: Groningen
country: Netherlands
facility: Recordati Investigative Site
city: San Isidro
country: Peru
facility: Recordati Investigative Site
state: Lima
city: Gdansk
country: Poland
facility: Recordati Investigative Site
city: Poznan
country: Poland
facility: Recordati Investigative Site
city: Warszawa
country: Poland
facility: Recordati Investigative Site
city: Wroclaw
country: Poland
facility: Recordati Investigative Site
city: Porto
country: Portugal
facility: Recordati Investigative Site
city: Bucuresti
country: Romania
facility: Recordati Investigative Site
city: Barnaul
country: Russian Federation
facility: Recordati Investigative Site
city: Moscow
country: Russian Federation
facility: Recordati Investigative Site
city: Saint Petersburg
country: Russian Federation
facility: Recordati Investigative Site
city: Tyumen
country: Russian Federation
facility: Recordati Investigative Site
city: Alicante
country: Spain
facility: Recordati Investigative Site
state: Comunidad Valenciana
city: Barcelona
country: Spain
facility: Recordati Investigative Site
city: Lausanne
country: Switzerland
facility: Recordati Investigative Site
city: Zuerich
country: Switzerland
facility: Recordati Investigative Site
city: Taichung
country: Taiwan
facility: Recordati Investigative Site
city: Bangkok
country: Thailand
facility: Recordati Investigative Site
city: Bangkok
country: Thailand
facility: Recordati Investigative Site
city: Songkla
country: Thailand
facility: Recordati Investigative Site
city: Istanbul
country: Turkey
facility: Recordati Investigative Site
state: TUR
city: Ankara
country: Turkey
facility: Recordati Investigative Site
city: Antalya
country: Turkey
facility: Recordati Investigative Site
city: Istanbul
country: Turkey
facility: Recordati Investigative Site
city: Izmir
country: Turkey
facility: Recordati Investigative Site
city: Kocaeli
country: Turkey
facility: Recordati Investigative Site
Study officials:
affiliation: Recordati AG
name: Recordati
role: STUDY_DIRECTOR
References: