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



Status:Recruiting
Conditions:Prostate Cancer, Skin Cancer, Cancer, Cancer, Brain Cancer, Brain Cancer, Cardiology, Endocrine, Endocrine, Gastrointestinal
Therapuetic Areas:Cardiology / Vascular Diseases, Endocrinology, Gastroenterology, Oncology
Healthy:No
Age Range:18 - Any
Updated:2/3/2019
Start Date:January 14, 2013
End Date:June 12, 2023
Contact:Novartis Pharmaceuticals
Email:Novartis.email@novartis.com
Phone:1-888-669-6682

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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

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.

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, Oncology CD&MA study and who are
benefiting from treatment with pasireotide. Eligible patients are to be consented and can
then continue treatment with pasireotide 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.

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
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 screening). For female subjects on
the study the vasectomized male partner should be the sole partner for that
subject.

- 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
contraception

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
treatment

- 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.
We found this trial at
9
sites
New York, New York 10021
Principal Investigator: Eliza B. Geer
Phone: 646-888-1395
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Ann Arbor, Michigan 48109
Principal Investigator: Ariel Barkan
Phone: 734-936-8065
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Ann Arbor, MI
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Caba, Buenos Aires
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Caba,
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Chesapeake, Virginia 23321
Principal Investigator: James LaRocque
Phone: 757-966-4520
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Chesapeake, VA
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La Jolla, California 92037
Principal Investigator: Sunil Bhoyrul
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La Jolla, CA
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Los Angeles, California 90048
Principal Investigator: Andrew E Hendifar
Phone: +1 310 423 1047
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Los Angeles, CA
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New York, NY
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Seattle, Washington 98104
Principal Investigator: Zachary Litvak
Phone: 206-320-2800
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Seattle, WA
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Stanford, California 94304
Principal Investigator: Laurence Katznelson
Phone: 650-724-4131
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Stanford, CA
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