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

Sponsor
RECORDATI GROUP (Industry)
Overall Status
Active, not recruiting
CT.gov ID
NCT01794793
Collaborator
(none)
413
Enrollment
94
Locations
2
Arms
120
Anticipated Duration (Months)
4.4
Patients Per Site
0
Patients Per Site Per Month

Study Details

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.

Condition or Disease Intervention/Treatment Phase
Phase 4

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.

Study Design

Study Type:
Interventional
Actual Enrollment :
413 participants
Allocation:
Non-Randomized
Intervention Model:
Single Group Assignment
Masking:
None (Open Label)
Primary Purpose:
Treatment
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
Actual Study Start Date :
Jun 10, 2013
Anticipated Primary Completion Date :
Jun 9, 2023
Anticipated Study Completion Date :
Jun 9, 2023

Arms and Interventions

Arm Intervention/Treatment
Experimental: Pasireotide subcutaneous

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.

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.
Other Names:
  • SOM230; Signifor

    • 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.
    Other Names:
  • dostinex

    		•
    Experimental: Pasireotide Long Acting Release (LAR)

    10mg, 20mg, 40mg and 60mg. All doses to be taken q28days. Strength 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.
    Other Names:
  • SOM230; Signifor

    		•

    Outcome Measures

    Primary Outcome Measures

    1. Incidence of adverse events to evaluate long term safety data [Baseline up to approximately 10 years]

      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

    1. Percentage of patients with clinical benefit as assessed by the investigator [Baseline up to approximately 10 years]

      Clinical benefit rate as defined by Investigator based on the patients 24 hour Urinary Free Cortisol results.

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    18 Years and Older
    Sexes Eligible for Study:
    All
    Accepts Healthy Volunteers:
    No
    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.

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 Ximed Research SC - SOM230B2412 La Jolla California United States 92037
    2 Cedars Sinai Medical Center Cedars Sinai 4 Los Angeles California United States 90048
    3 Stanford Universtiy Medical Center Stanford Hospital & Clinics Stanford California United States 94304
    4 University of Michigan Comprehensive Cancer Center SC-2 Ann Arbor Michigan United States 48109
    5 Memorial Sloan-Kettering Cancer Center SC New York New York United States 10065
    6 Virginia Endocrinology Research SC Chesapeake Virginia United States 23321
    7 Swedish Cancer Institute Swedish Cancer Institute (SC) Seattle Washington United States 98104
    8 Recordati Investigative Site Caba Buenos Aires Argentina C1405BCH
    9 Recordati Investigative Site Mar del Plata Buenos Aires Argentina B7602CBM
    10 Recordati Investigative Site Edegem Antwerpen Belgium 2650
    11 Recordati Investigative Site Brugge Belgium 8310
    12 Recordati Investigative Site Brussel Belgium 1090
    13 Recordati Investigative Site Bruxelles Belgium 1200
    14 Recordati Investigative Site Gent Belgium 9000
    15 Recordati Investigative Site Leuven Belgium 3000
    16 Recordati Investigative Site Liege Belgium 4000
    17 Recordati Investigative Site Wilrijk Belgium 2610
    18 Recordati Investigative Site Fortaleza CE Brazil 60430 370
    19 Recordati Investigative Site Curitiba PR Brazil 80030-110
    20 Recordati Investigative Site Rio de Janeiro RJ Brazil 21941-913
    21 Recordati Investigative Site Porto Alegre RS Brazil 90560 030
    22 Recordati Investigative Site Joinville SC Brazil 89201260
    23 Recordati Investigative Site Botucatu SP Brazil 18618-970
    24 Recordati Investigative Site Sao Paulo SP Brazil 05403 000
    25 Recordati Investigative Site Sofia Bulgaria 1431
    26 Recordati Investigative Site Halifax Nova Scotia Canada B3H 1V7
    27 Recordati Investigative Site London Ontario Canada N6A 4L6
    28 Recordati Investigative Site Montreal Quebec Canada H2L 4M1
    29 Recordati Investigative Site Montreal Quebec Canada H2W 1T8
    30 Recordati Investigative Site Toulouse Cedex 9 France 31000
    31 Recordati Investigative Site Angers cedex 09 France 49933
    32 Recordati Investigative Site Bron Cedex France 69677
    33 Recordati Investigative Site Le Kremlin Bicetre France 94275
    34 Recordati Investigative Site Lille Cedex France 59037
    35 Recordati Investigative Site Marseille cedex 05 France 13385
    36 Recordati Investigative Site Pessac Cedex France 33604
    37 Recordati Investigative Site Pierre Benite Cedex France 69495
    38 Recordati Investigative Site Berlin Germany 13353
    39 Recordati Investigative Site Hamburg Germany 20246
    40 Recordati Investigative Site Muenchen Germany 81377
    41 Recordati Investigative Site Muenchen Germany 81667
    42 Recordati Investigative Site Tübingen Germany 72076
    43 Recordati Investigative Site Ulm Germany 89081
    44 Recordati Investigative Site Wuerzburg Germany 97080
    45 Recordati Investigative Site Athens GR Greece 115 27
    46 Recordati Investigative Site Budapest Hungary 1085
    47 Recordati Investigative Site Bangalore Karnataka India 560054
    48 Recordati Investigative Site Vellore Tamil Nadu India 632004
    49 Recordati Investigative Site Petach Tikva Israel 49100
    50 Recordati Investigative Site Ancona AN Italy 60126
    51 Recordati Investigative Site Genova GE Italy 16132
    52 Milano Investigative Site Milano MI Italy 20149
    53 Recordati Investigative Site Padova PD Italy 35128
    54 Recordati Investigative Site Roma RM Italy 00168
    55 Recordati Investigative Site Nagoya Aichi Japan 460-0001
    56 Recordati Investigative Site Maebashi city Gunma Japan 371 8511
    57 Recordati Investigative Site Kobe-shi Hyogo Japan 650-0017
    58 Recordati Investigative Site Nankoku city Kochi Japan 783 8505
    59 Recordati Investigative Site Kyoto-city Kyoto Japan 612-8555
    60 Recordati Investigative Site Suita city Osaka Japan 565 0871
    61 Recordati Investigative Site Seoul Korea, Republic of 03722
    62 Recordati Investigative Site Seoul Korea, Republic of 06351
    63 Recordati Investigative Site Kuala Lumpur Malaysia 62502
    64 Recordati Investigative Site Pulau Pinang Malaysia 10990
    65 Recordati Investigative Site México Distrito Federal Mexico 14269
    66 Recordati Investigative Site Guadalajara Jalisco Mexico 44130
    67 Recordati Investigative Site Durango Mexico 34270
    68 Recordati Investigative Site Mexico City Mexico 07760
    69 Recordati Investigative Site Groningen Netherlands 9713 GZ
    70 Recordati Investigative Site San Isidro Lima Peru 27
    71 Recordati Investigative Site Gdansk Poland 80 952
    72 Recordati Investigative Site Poznan Poland 60-355
    73 Recordati Investigative Site Warszawa Poland 04141
    74 Recordati Investigative Site Wroclaw Poland 50 367
    75 Recordati Investigative Site Porto Portugal 4200-319
    76 Recordati Investigative Site Bucuresti Romania 011863
    77 Recordati Investigative Site Barnaul Russian Federation 656024
    78 Recordati Investigative Site Moscow Russian Federation 123317
    79 Recordati Investigative Site Saint Petersburg Russian Federation 197341
    80 Recordati Investigative Site Tyumen Russian Federation 625023
    81 Recordati Investigative Site Alicante Comunidad Valenciana Spain 03010
    82 Recordati Investigative Site Barcelona Spain 08041
    83 Recordati Investigative Site Lausanne Switzerland 1011
    84 Recordati Investigative Site Zuerich Switzerland 8091
    85 Recordati Investigative Site Taichung Taiwan 40705
    86 Recordati Investigative Site Bangkok Thailand 10400
    87 Recordati Investigative Site Bangkok Thailand 10700
    88 Recordati Investigative Site Songkla Thailand 90110
    89 Recordati Investigative Site Istanbul TUR Turkey 34098
    90 Recordati Investigative Site Ankara Turkey 06500
    91 Recordati Investigative Site Antalya Turkey 07070
    92 Recordati Investigative Site Istanbul Turkey 34890
    93 Recordati Investigative Site Izmir Turkey 35340
    94 Recordati Investigative Site Kocaeli Turkey 41380

    Sponsors and Collaborators

    • RECORDATI GROUP

    Investigators

    • Study Director: Recordati, Recordati AG

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    None provided.
    Responsible Party:
    RECORDATI GROUP
    ClinicalTrials.gov Identifier:
    NCT01794793
    Other Study ID Numbers:
    • CSOM230B2412
    First Posted:
    Feb 20, 2013
    Last Update Posted:
    May 26, 2022
    Last Verified:
    May 1, 2022
    Studies a U.S. FDA-regulated Drug Product:
    Yes
    Studies a U.S. FDA-regulated Device Product:
    No
    Keywords provided by RECORDATI GROUP
    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
    Additional relevant MeSH terms:
    Prostatic Neoplasms
    Melanoma
    Neuroendocrine Tumors
    Pituitary Neoplasms
    ACTH-Secreting Pituitary Adenoma
    Acromegaly
    Dumping Syndrome
    Pituitary Diseases
    Pituitary ACTH Hypersecretion
    Cabergoline
    Pasireotide
    Somatostatin

    Study Results

    No Results Posted as of May 26, 2022