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

NCT01794793 | Completed Phase 4 Results FDA Drug

• 1 other identifier: CSOM230B2412
• Study Type: interventional
• Target: 337
• Locations: 28 countries
• Sites: 94

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.

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

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (1)

• Percentage of Patients With Clinical Benefit as Assessed by the Investigator

  Baseline up to approximately 10 years

Study Arms (2)

Pasireotide subcutaneous

EXPERIMENTAL

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; Drug: Cabergoline

Pasireotide Long Acting Release (LAR)

EXPERIMENTAL

10mg, 20mg, 40mg and 60mg. All doses to be taken q28days. Strength is dependent on parent study guidelines.

Drug: Pasireotide LAR

Interventions

Pasireotide DRUG

Administered subcutaneously in strengths 0.3mg, 0.6mg and 0.9mg. Doses to be taken BID or TID, dependent on parent study guidelines.

Also known as: SOM230; Signifor

Pasireotide subcutaneous

Cabergoline DRUG

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.

Also known as: dostinex

Pasireotide subcutaneous

Pasireotide LAR DRUG

Long Acting Release is administered by a single intramuscular (i.m.) monthly injection. The strengths are 10mg, 20mg, 40mg and 60mg. All doses to be taken q28days. Strength is dependent on parent study guidelines.

Also known as: SOM230; Signifor

Pasireotide Long Acting Release (LAR)

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.
• Patient is currently benefiting from the treatment with pasireotide, as determined by the investigator
• Patient has demonstrated compliance, as assessed by the investigator, with the parent study requirements.
• Willingness and ability to comply with scheduled visits, treatment plans and any other study procedures.
• 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.

You may not qualify if:

• 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.
• 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.
• 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.

Sponsors & Collaborators

• RECORDATI GROUP: lead

Study Sites (94)

Ximed Research SC - SOM230B2412

La Jolla, California, 92037, United States

Location

Cedars Sinai Medical Center Cedars Sinai 4

Los Angeles, California, 90048, United States

Location

Stanford Universtiy Medical Center Stanford Hospital & Clinics

Stanford, California, 94304, United States

Location

University of Michigan Comprehensive Cancer Center SC-2

Ann Arbor, Michigan, 48109, United States

Location

Memorial Sloan-Kettering Cancer Center SC

New York, New York, 10065, United States

Location

Virginia Endocrinology Research SC

Chesapeake, Virginia, 23321, United States

Location

Swedish Cancer Institute Swedish Cancer Institute (SC)

Seattle, Washington, 98104, United States

Location

Recordati Investigative Site

CABA, Buenos Aires, C1405BCH, Argentina

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Mar del Plata, Buenos Aires, B7602CBM, Argentina

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Edegem, Antwerpen, 2650, Belgium

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Bruges, 8310, Belgium

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Brussels, 1090, Belgium

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Brussels, 1200, Belgium

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Ghent, 9000, Belgium

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Leuven, 3000, Belgium

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Liège, 4000, Belgium

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Wilrijk, 2610, Belgium

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Fortaleza, Ceará, 60430 370, Brazil

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Curitiba, Paraná, 80030-110, Brazil

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Rio de Janeiro, Rio de Janeiro, 21941-913, Brazil

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Porto Alegre, Rio Grande do Sul, 90560 030, Brazil

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Joinville, Santa Catarina, 89201260, Brazil

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Botucatu, São Paulo, 18618-970, Brazil

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São Paulo, São Paulo, 05403 000, Brazil

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Sofia, 1431, Bulgaria

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Halifax, Nova Scotia, B3H 1V7, Canada

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London, Ontario, N6A 4L6, Canada

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Montreal, Quebec, H2L 4M1, Canada

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Montreal, Quebec, H2W 1T8, Canada

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Toulouse, Cedex 9, 31000, France

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Angers, 49933, France

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Bron, 69677, France

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Le Kremlin-Bicêtre, 94275, France

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Lille, 59037, France

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Marseille, 13385, France

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Pessac, 33604, France

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Pierre-Bénite, 69495, France

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Berlin, 13353, Germany

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Hamburg, 20246, Germany

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München, 81377, Germany

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München, 81667, Germany

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Tübingen, 72076, Germany

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Ulm, 89081, Germany

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Würzburg, 97080, Germany

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Athens, GR, 115 27, Greece

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Budapest, 1085, Hungary

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Bangalore, Karnataka, 560054, India

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Vellore, Tamil Nadu, 632004, India

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Petah Tikva, 49100, Israel

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Ancona, AN, 60126, Italy

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Genova, GE, 16132, Italy

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Milano Investigative Site

Milan, MI, 20149, Italy

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Padua, PD, 35128, Italy

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Roma, RM, 00168, Italy

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Nagoya, Aichi-ken, 460-0001, Japan

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Maebashi, Gunma, 371 8511, Japan

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Kobe, Hyōgo, 650-0017, Japan

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Nankoku, Kochi, 783 8505, Japan

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Kyoto, Kyoto, 612-8555, Japan

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Suita, Osaka, 565 0871, Japan

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Kuala Lumpur, 62502, Malaysia

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Pulau Pinang, 10990, Malaysia

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Guadalajara, Jalisco, 44130, Mexico

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Mexico City, Mexico City, 14269, Mexico

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Durango, 34270, Mexico

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Mexico City, 07760, Mexico

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Groningen, 9713 GZ, Netherlands

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San Isidro, Lima region, 27, Peru

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Gdansk, 80 952, Poland

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Poznan, 60-355, Poland

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Warsaw, 04141, Poland

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Wroclaw, 50 367, Poland

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Porto, 4200-319, Portugal

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Bucharest, 011863, Romania

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Barnaul, 656024, Russia

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Moscow, 123317, Russia

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Saint Petersburg, 197341, Russia

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Tyumen, 625023, Russia

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Seoul, 03722, South Korea

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Seoul, 06351, South Korea

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Alicante, Valencia, 03010, Spain

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Barcelona, 08041, Spain

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Lausanne, 1011, Switzerland

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Zurich, 8091, Switzerland

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Taichung, 40705, Taiwan

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Bangkok, 10400, Thailand

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Bangkok, 10700, Thailand

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Songkhla, 90110, Thailand

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Istanbul, TUR, 34098, Turkey (Türkiye)

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Ankara, 06500, Turkey (Türkiye)

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Antalya, 07070, Turkey (Türkiye)

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Istanbul, 34890, Turkey (Türkiye)

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Izmir, 35340, Turkey (Türkiye)

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Kocaeli, 41380, Turkey (Türkiye)

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MeSH Terms

Conditions

Pituitary ACTH Hypersecretion; Acromegaly; Neuroendocrine Tumors; Pituitary Neoplasms; Neoplasms; Dumping Syndrome; Prostatic Neoplasms; Melanoma

Interventions

pasireotide; Cabergoline

Condition Hierarchy (Ancestors)

Hyperpituitarism; Pituitary Diseases; Hypothalamic Diseases; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Endocrine System Diseases; Bone Diseases, Endocrine; Bone Diseases; Musculoskeletal Diseases; Neuroectodermal Tumors; Neoplasms, Germ Cell and Embryonal; Neoplasms by Histologic Type; Neoplasms, Nerve Tissue; Endocrine Gland Neoplasms; Neoplasms by Site; Hypothalamic Neoplasms; Supratentorial Neoplasms; Brain Neoplasms; Central Nervous System Neoplasms; Nervous System Neoplasms; Postgastrectomy Syndromes; Stomach Diseases; Gastrointestinal Diseases; Digestive System Diseases; Postoperative Complications; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Genital Neoplasms, Male; Urogenital Neoplasms; Genital Diseases, Male; Genital Diseases; Urogenital Diseases; Prostatic Diseases; Male Urogenital Diseases; Nevi and Melanomas; Skin Neoplasms; Skin Diseases; Skin and Connective Tissue Diseases

Intervention Hierarchy (Ancestors)

Ergolines; Ergot Alkaloids; Alkaloids; Heterocyclic Compounds; Heterocyclic Compounds, 4 or More Rings; Heterocyclic Compounds, Fused-Ring

Results Point of Contact

• Title: Mario Maldonado, MD / Head of Clinical Development Global Endocrinology
• Organization: RECORDATIGROUP

maldonado.m@recordati.com

+41798030344

Study Officials

• Recordati

  Recordati AG

  STUDY DIRECTOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: Yes

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: February 15, 2013
• First Posted: February 20, 2013
• Study Start: June 10, 2013
• Primary Completion: July 25, 2023
• Study Completion: July 25, 2023
• Last Updated: October 1, 2024
• Results First Posted: August 28, 2024

Record last verified: 2024-08

Data Sharing

• IPD Sharing: Will share

Locations

TU (6); DE (7); BR (7); CA (4); HU (1); RU (4); BU (1); FR (8); ME (4); IL (1); PL (4); NL (1); PT (1); US (7); RO (1); MY (2); KR (2); ES (2); CH (2); TW (1); TH (3); JP (6); IT (5); AR (2); GR (1); BE (8); IN (2); PE (1)