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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


Phase 4
18 Years
N/A
Not Enrolling
Both
Cushing's Disease,, Acromegaly,, Neuroendocrine Tumors,, Pituitary Tumors, Ectopic ACTH Secreting (EAS) Tumors,, Dumping Syndrome,, Prostate Cancer,, Melanoma Negative for bRAF,, Melanoma Negative for nRAS

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Trial Information

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


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.

Type of Study:

Interventional

Study Design:

Endpoint Classification: Safety Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Outcome Measure:

Number of patients receiving pasireotide

Outcome Description:

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. A patient will reach the end of study when pasireotide treatment is permanently discontinued.

Outcome Time Frame:

Approximately 10 years

Safety Issue:

Yes

Principal Investigator

Novartis Pharmaceuticals

Investigator Role:

Study Director

Investigator Affiliation:

Novartis Pharmaceuticals

Authority:

United States: Food and Drug Administration

Study ID:

CSOM230B2412

NCT ID:

NCT01794793

Start Date:

May 2013

Completion Date:

April 2023

Related Keywords:

  • Cushing's Disease,
  • Acromegaly,
  • Neuroendocrine Tumors,
  • Pituitary Tumors
  • Ectopic ACTH Secreting (EAS) Tumors,
  • Dumping Syndrome,
  • Prostate Cancer,
  • Melanoma Negative for bRAF,
  • Melanoma Negative for nRAS
  • SOM230,
  • roll-over study,
  • pasireotide LAR,
  • Cushing's disease,
  • Acromegaly,
  • neuroendocrine tumors,
  • NETs,
  • pituitary tumors,
  • Ectopic ACTH secreting,
  • EAS,
  • Dumping Syndrome,
  • metastatic prostate cancer, metastatic melanoma,
  • bRAF,
  • nRAS
  • Acromegaly
  • Cushing Syndrome
  • Pituitary ACTH Hypersecretion
  • Dumping Syndrome
  • Melanoma
  • Pituitary Neoplasms
  • Prostatic Neoplasms
  • Neuroendocrine Tumors
  • Cardiac Complexes, Premature

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