Prostate Cancer Clinical Trial
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
Verified date | May 2024 |
Source | RECORDATI GROUP |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
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.
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. |
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 |
Lead Sponsor | Collaborator |
---|---|
RECORDATI GROUP |
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,
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 |
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