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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT01794793
Recruitment Status : Active, not recruiting
First Posted : February 20, 2013
Last Update Posted : November 3, 2020
Sponsor:
Information provided by (Responsible Party):
RECORDATI GROUP

Tracking Information
First Submitted Date  ICMJE February 15, 2013
First Posted Date  ICMJE February 20, 2013
Last Update Posted Date November 3, 2020
Actual Study Start Date  ICMJE June 10, 2013
Estimated Primary Completion Date June 9, 2023   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: July 7, 2019)
Incidence of adverse events to evaluate long term safety data [ Time Frame: Baseline up to approximately 10 years ]
Collect long term safety data, i.e. SAEs and AEs. SAES will be reviewed and reported as part of the regular pharmacovigilance activities.
Original Primary Outcome Measures  ICMJE
 (submitted: February 15, 2013)
Number of patients receiving pasireotide [ Time Frame: Approximately 10 years ]
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.
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: July 7, 2019)
Percentage of patients with clinical benefit as assessed by the investigator [ Time Frame: Baseline up to approximately 10 years ]
Clinical benefit rate as defined by Investigator based on the patients 24 hour Urinary Free Cortisol results.
Original Secondary Outcome Measures  ICMJE
 (submitted: February 15, 2013)
Frequency and nature of serious adverse events (SAEs) [ Time Frame: as necessary up to 10 years ]
Collect long term safety data, i.e. SAEs and 'AEs of special interest'. SAES will be reviewed and reported as part of the regular pharmacovigilance activities.
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Study to Allow Access to Pasireotide for Patients Benefiting From Pasireotide Treatment in Novartis-sponsored Studies
Official Title  ICMJE 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 Type  ICMJE Interventional
Study Phase  ICMJE Phase 4
Study Design  ICMJE Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Condition  ICMJE
  • 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
Intervention  ICMJE
  • Drug: Pasireotide
    Administered subcutaneously in strengths 0.3mg, 0.6mg and 0.9mg. Doses to be taken BID or TID, dependent on parent study guidelines.
    Other Name: SOM230; Signifor
  • Drug: Cabergoline
    Cabergoline tablet 0.5mg or 1.0mg taken by mouth once daily may be combined with subcutaneous formulation of pasireotide for Cushing's Disease or Acromegaly. Dose is dependent on parent study guidelines.
    Other Name: dostinex
  • Drug: Pasireotide
    Long Acting Release is administered by monthly injection. The strengths are 10mg, 20mg, 40mg and 60mg. All doses to be taken q28days. Strength is dependent on parent study guidelines.
    Other Name: SOM230; Signifor
Study Arms  ICMJE
  • Experimental: Pasireotide subcutaneous
    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.
    Interventions:
    • Drug: Pasireotide
    • Drug: Cabergoline
  • Experimental: Pasireotide Long Acting Release (LAR)
    10mg, 20mg, 40mg and 60mg. All doses to be taken q28days. Strength is dependent on parent study guidelines.
    Intervention: Drug: Pasireotide
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Active, not recruiting
Actual Enrollment  ICMJE
 (submitted: June 19, 2020)
413
Original Estimated Enrollment  ICMJE
 (submitted: February 15, 2013)
100
Estimated Study Completion Date  ICMJE June 9, 2023
Estimated Primary Completion Date June 9, 2023   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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.
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE Argentina,   Belgium,   Brazil,   Bulgaria,   Canada,   France,   Germany,   Greece,   Hungary,   India,   Israel,   Italy,   Japan,   Korea, Republic of,   Malaysia,   Mexico,   Netherlands,   Peru,   Poland,   Portugal,   Romania,   Russian Federation,   Spain,   Switzerland,   Taiwan,   Thailand,   Turkey,   United States
Removed Location Countries China
 
Administrative Information
NCT Number  ICMJE NCT01794793
Other Study ID Numbers  ICMJE CSOM230B2412
Has Data Monitoring Committee No
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
IPD Sharing Statement  ICMJE Not Provided
Responsible Party RECORDATI GROUP
Study Sponsor  ICMJE RECORDATI GROUP
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Study Director: Recordati Recordati AG
PRS Account RECORDATI GROUP
Verification Date September 2020

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP