Trial Search Results

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

The purpose of this study is to allow continued use of pasireotide in patients who are on pasireotide treatment in a Novartis-sponsored, Oncology Clinical Development & Medical Affairs (CD&MA) study and are benefiting from the treatment as judged by the investigator.

Stanford is currently not accepting patients for this trial.

Lead Sponsor:

Novartis Pharmaceuticals

Stanford Investigator(s):


  • Drug: Pasireotide


Phase 4


Inclusion Criteria:

   - Patient is currently participating in a Novartis Oncology sponsored study receiving
   pasireotide (LAR and/or s.c.) and has fulfilled all required assessments in the parent
   study (unless the study is being terminated) and patients that are benefiting from the
   study drug 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

Exclusion Criteria:

   - 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

   - Patient has participated in a Novartis sponsored combination trial where pasireotide
   was dispensed in combination with another study medication and is still receiving
   combination therapy. (only patients receiving pasireotide monotherapy can be included)

   - 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 dosing and for 1 months after pasireotide s.c. last dose and 3 months after
   pasireotide LAR last dose Highly effective contraception methods include:

      - Total abstinence (when this is in line with the preferred and usual lifestyle of
      the subject. 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 screening). For female subjects on
      the study the vasectomized male partner should be the sole partner for that

      - Combination of any two of the following (a+b or a+c, or b+c):

         1. Use of oral, injected or implanted hormonal methods of contraception or
         other forms of hormonal contraception that have comparable efficacy (failure
         rate <1%), for example hormone vaginal ring or transdermal hormone

         2. Placement of an intrauterine device (IUD) or intrauterine system (IUS)

         3. Barrier methods of contraception: Condom or Occlusive cap diaphragm or
         cervical/vault caps) with spermicidal foam/gel/film/cream/vaginal
         suppository 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

   - 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 and 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 If a study patient or partner becomes pregnant or suspects being pregnant during
   the study or within 1 month after the final dose of pasireotide s.c. or 3 months after
   the final dose of pasireotide LAR, the Study Doctor needs to be informed immediately
   and ongoing study treatment with pasireotide has to be stopped immediately For
   patients taking pasireotide LAR, the future dose injections will be cancelled.

Ages Eligible for Study

18 Years - N/A

Genders Eligible for Study


Not currently accepting new patients for this trial

Contact Information

Stanford University
School of Medicine
300 Pasteur Drive
Stanford, CA 94305
Daniel Lebus
Not Recruiting