Clinical Trials Logo

Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT01794793
Other study ID # CSOM230B2412
Secondary ID
Status Completed
Phase Phase 4
First received
Last updated
Start date June 10, 2013
Est. completion date July 29, 2023

Study information

Verified date May 2024
Source RECORDATI GROUP
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial 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.


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.


Recruitment information / eligibility

Status Completed
Enrollment 413
Est. completion date July 29, 2023
Est. primary completion date July 29, 2023
Accepts healthy volunteers No
Gender All
Age group 18 Years and older
Eligibility 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.

Study Design


Intervention

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.
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.
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.

Locations

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

Sponsors (1)

Lead Sponsor Collaborator
RECORDATI GROUP

Countries where clinical trial is conducted

United States,  Argentina,  Belgium,  Brazil,  Bulgaria,  Canada,  France,  Germany,  Greece,  Hungary,  India,  Israel,  Italy,  Japan,  Korea, Republic of,  Malaysia,  Mexico,  Netherlands,  Peru,  Poland,  Portugal,  Romania,  Russian Federation,  Spain,  Switzerland,  Taiwan,  Thailand,  Turkey, 

Outcome

Type Measure Description Time frame Safety issue
Primary 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. Baseline up to approximately 10 years
Secondary 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. Baseline up to approximately 10 years
See also
  Status Clinical Trial Phase
Recruiting NCT05540392 - An Acupuncture Study for Prostate Cancer Survivors With Urinary Issues Phase 1/Phase 2
Recruiting NCT05613023 - A Trial of 5 Fraction Prostate SBRT Versus 5 Fraction Prostate and Pelvic Nodal SBRT Phase 3
Recruiting NCT05156424 - A Comparison of Aerobic and Resistance Exercise to Counteract Treatment Side Effects in Men With Prostate Cancer Phase 1/Phase 2
Completed NCT03177759 - Living With Prostate Cancer (LPC)
Completed NCT01331083 - A Phase II Study of PX-866 in Patients With Recurrent or Metastatic Castration Resistant Prostate Cancer Phase 2
Recruiting NCT05540782 - A Study of Cognitive Health in Survivors of Prostate Cancer
Active, not recruiting NCT04742361 - Efficacy of [18F]PSMA-1007 PET/CT in Patients With Biochemial Recurrent Prostate Cancer Phase 3
Completed NCT04400656 - PROState Pathway Embedded Comparative Trial
Completed NCT02282644 - Individual Phenotype Analysis in Patients With Castration-Resistant Prostate Cancer With CellSearch® and Flow Cytometry N/A
Recruiting NCT06305832 - Salvage Radiotherapy Combined With Androgen Deprivation Therapy (ADT) With or Without Rezvilutamide in the Treatment of Biochemical Recurrence After Radical Prostatectomy for Prostate Cancer Phase 2
Recruiting NCT06037954 - A Study of Mental Health Care in People With Cancer N/A
Recruiting NCT05761093 - Patient and Physician Benefit/ Risk Preferences for Treatment of mPC in Hong Kong: a Discrete Choice Experiment
Completed NCT04838626 - Study of Diagnostic Performance of [18F]CTT1057 for PSMA-positive Tumors Detection Phase 2/Phase 3
Recruiting NCT03101176 - Multiparametric Ultrasound Imaging in Prostate Cancer N/A
Completed NCT03290417 - Correlative Analysis of the Genomics of Vitamin D and Omega-3 Fatty Acid Intake in Prostate Cancer N/A
Completed NCT00341939 - Retrospective Analysis of a Drug-Metabolizing Genotype in Cancer Patients and Correlation With Pharmacokinetic and Pharmacodynamics Data
Completed NCT01497925 - Ph 1 Trial of ADI-PEG 20 Plus Docetaxel in Solid Tumors With Emphasis on Prostate Cancer and Non-Small Cell Lung Cancer Phase 1
Recruiting NCT03679819 - Single-center Trial for the Validation of High-resolution Transrectal Ultrasound (Exact Imaging Scanner ExactVu) for the Detection of Prostate Cancer
Completed NCT03554317 - COMbination of Bipolar Androgen Therapy and Nivolumab Phase 2
Completed NCT03271502 - Effect of Anesthesia on Optic Nerve Sheath Diameter in Patients Undergoing Robot-assisted Laparoscopic Prostatectomy N/A