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NCT01794793·Phase 4·INTERVENTIONAL

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

Status

Completed

Phase

Phase 4

Enrollment

337

Locations

94

Results

Posted

Publications

0

Study summary

What the protocol is testing.

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.

Full 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.

Interventions

Treatment arms and agents.

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.

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.

DRUG

Pasireotide LAR

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.

Timeline

From registration to results.

  1. First posted

    Feb 20, 2013

  2. Study start

    Jun 10, 2013

  3. Primary completion

    Jul 25, 2023

  4. Study completion

    Jul 25, 2023

  5. Results posted

    Aug 28, 2024

  6. Registry updated

    Oct 1, 2024

Outcomes

What the study measures.

Primary outcomes

Incidence of Adverse Events to Evaluate Long Term Safety Data

Time frame · 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 outcomes

Percentage of Patients With Clinical Benefit as Assessed by the Investigator

Time frame · Baseline up to approximately 10 years

Efficacy was assessed by the investigator at each scheduled visit using a binary (yes/no) response confirming the investigator's judgement of clinical benefit (via the question: "Does investigator confirm that the subject continues to have clinical benefit from the study treatment"). No other measures of efficacy were used in this study.

Eligibility

Who can take part.

Minimum age
18 Years
Maximum age
Not reported
Sex
ALL
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.

Study locations

94 registered sites.

Argentina · Belgium · Brazil · Bulgaria · Canada · France · Germany · Greece · Hungary · India · Israel · Italy · Japan · Malaysia · Mexico · Netherlands · Peru · Poland · Portugal · Romania · Russia · South Korea · Spain · Switzerland · Taiwan · Thailand · Turkey (Türkiye) · United States. Showing up to 24 locations stored in the fast local snapshot.

Ximed Research SC - SOM230B2412

La Jolla, California, United States

Cedars Sinai Medical Center Cedars Sinai 4

Los Angeles, California, United States

Stanford Universtiy Medical Center Stanford Hospital & Clinics

Stanford, California, United States

University of Michigan Comprehensive Cancer Center SC-2

Ann Arbor, Michigan, United States

Memorial Sloan-Kettering Cancer Center SC

New York, New York, United States

Virginia Endocrinology Research SC

Chesapeake, Virginia, United States

Swedish Cancer Institute Swedish Cancer Institute (SC)

Seattle, Washington, United States

Recordati Investigative Site

CABA, Buenos Aires, Argentina

Recordati Investigative Site

Mar del Plata, Buenos Aires, Argentina

Recordati Investigative Site

Edegem, Antwerpen, Belgium

Recordati Investigative Site

Bruges, Belgium

Recordati Investigative Site

Brussels, Belgium

Recordati Investigative Site

Brussels, Belgium

Recordati Investigative Site

Ghent, Belgium

Recordati Investigative Site

Leuven, Belgium

Recordati Investigative Site

Liège, Belgium

Recordati Investigative Site

Wilrijk, Belgium

Recordati Investigative Site

Fortaleza, Ceará, Brazil

Recordati Investigative Site

Curitiba, Paraná, Brazil

Recordati Investigative Site

Rio de Janeiro, Rio de Janeiro, Brazil

Recordati Investigative Site

Porto Alegre, Rio Grande do Sul, Brazil

Recordati Investigative Site

Joinville, Santa Catarina, Brazil

Recordati Investigative Site

Botucatu, São Paulo, Brazil

Recordati Investigative Site

São Paulo, São Paulo, Brazil

Publications

Results and literature.

No PMID-linked publications were present in this registry snapshot.

Primary links

Continue at the source.

Related trials

More studies on Pasireotide.

Related PeptideStat pages

Put the record in context.

Research pages describe evidence. Vendor pages, where available, describe independently tracked research-product listings and are not clinical recommendations.