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

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Brief Title

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

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

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.
    

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.
    

Study Phase

Phase 4

Study Type

Interventional


Primary Outcome

Incidence of adverse events to evaluate long term safety data

Secondary Outcome

 Percentage of patients with clinical benefit as assessed by the investigator

Condition

Cushing's Disease

Intervention

Pasireotide

Study Arms / Comparison Groups

 Pasireotide subcutaneous
Description:  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.

Publications

* Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline.

Recruitment Information


Recruitment Status

Drug

Estimated Enrollment

413

Start Date

June 10, 2013

Completion Date

June 9, 2023

Primary Completion Date

June 9, 2023

Eligibility Criteria

        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.
      

Gender

All

Ages

18 Years - N/A

Accepts Healthy Volunteers

No

Contacts

Novartis Pharmaceuticals, , 

Location Countries

Argentina

Location Countries

Argentina

Administrative Informations


NCT ID

NCT01794793

Organization ID

CSOM230B2412


Responsible Party

Sponsor

Study Sponsor

Novartis Pharmaceuticals


Study Sponsor

Novartis Pharmaceuticals, Study Director, Novartis Pharmaceuticals


Verification Date

September 2020