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

Not Recruiting

Trial ID: NCT01794793


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.

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

Stanford Investigator(s)


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

      - 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

      - 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.


drug: Pasireotide

drug: Pasireotide

drug: Cabergoline

Not Recruiting

Contact Information

Stanford University
School of Medicine
300 Pasteur Drive
Stanford, CA 94305
Daniel Lebus