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

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

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT01794793
• Other study ID #: CSOM230B2412
• Status: Active, not recruiting
• Phase: Phase 4
• Start date: June 10, 2013
• Est. completion date: June 9, 2023

Study information

• Verified date: May 2022
• Source: RECORDATI GROUP
• Contact: n/a
• Is FDA regulated: No
• 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: Active, not recruiting
• Enrollment: 413
• Est. completion date: June 9, 2023
• Est. primary completion date: June 9, 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.

Related Conditions & MeSH terms

• Acromegaly
• ACTH-Secreting Pituitary Adenoma
• Cushing's Disease
• Dumping Syndrome
• Ectopic ACTH Secreting (EAS) Tumors
• Melanoma
• Melanoma Negative for bRAF
• Melanoma Negative for nRAS
• Neuroendocrine Tumors
• Pituitary ACTH Hypersecretion
• Pituitary Diseases
• Pituitary Neoplasms
• Pituitary Tumors
• Prostate Cancer
• Prostatic Neoplasms

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