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Trial · Interventional

CompletedPhase 4Results postedRegistry data

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

Overview

Status
Completed
Phase
Phase 4
Enrollment
337 participants (actual)
Sponsor
RECORDATI GROUP · Industry
Design
Not randomized · Open label (no masking)
Countries
28 countries

United States, Argentina, Belgium, Brazil, Bulgaria, Canada, France, Germany, Greece, Hungary, India, Israel, Italy, Japan, Malaysia, Mexico, Netherlands, Peru, Poland, Portugal, Romania, Russia, South Korea, Spain, Switzerland, Taiwan, Thailand, Turkey (Türkiye)

Start
10 Jun 2013
Primary completion
25 Jul 2023
Completion
25 Jul 2023
First posted
20 Feb 2013 (estimated)
Last update posted
1 Oct 2024
Conditions
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

Timeline

1 trial · 1 completed · 1 with posted results

  • Completed
  • Ongoing
  • Not yet recruiting
  • Stopped
  • Estimated dates (est.)
  • Results posted
201420162018202020222024
  1. Ph 4

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

    NCT01794793

    10 Jun 2013 to 25 Jul 2023

Registry summary

Text and fields below are the sponsor's entries at ClinicalTrials.gov, shown as posted.

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.

Interventions

  • PasireotideDrug
  • CabergolineDrug
  • Pasireotide LARDrug

Arms2

  • 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.

  • Experimental

    Pasireotide Long Acting Release (LAR)

    10mg, 20mg, 40mg and 60mg. All doses to be taken q28days. Strength is dependent on parent study guidelines.

Primary outcomes1

Outcomes the sponsor listed as primary.

  1. Incidence of Adverse Events to Evaluate Long Term Safety Data

    Time frame · Baseline up to approximately 10 years

    Registry description

    Collect long term safety data, i.e. SAEs and AEs. SAES will be reviewed and reported as part of the regular pharmacovigilance activities.

Secondary outcomes(1)
  1. Percentage of Patients With Clinical Benefit as Assessed by the Investigator

    Time frame · Baseline up to approximately 10 years

    Registry description

    Efficacy was assessed by the investigator at each scheduled visit using a binary (yes/no) response confirming the investigator's judgement of clinical benefit (via the question: "Does investigator confirm that the subject continues to have clinical benefit from the study treatment"). No other measures of efficacy were used in this study.

Posted results

Values are shown as posted at ClinicalTrials.gov, with their units. PepBank has not converted, pooled or compared them.

Primary outcome results

Primary outcomeNumber· Baseline up to approximately 10 years

Incidence of Adverse Events to Evaluate Long Term Safety Data

GroupValue (participants)
All Subjects265
Secondary and other outcome results(1)
Secondary outcomeCount of participants· Baseline up to approximately 10 years

Percentage of Patients With Clinical Benefit as Assessed by the Investigator

GroupValue (Participants)
Pasireotide Subcutaneous29
Pasireotide Long Acting Release (LAR)256

Adverse events, as posted

Adverse events as posted: participants affected out of participants at risk, by group
GroupDeathsSerious eventsOther events
All SubjectsPatients who were treated with and had benefitted from pasireotide in the parent studies remained enrolled in this study and were elegible for the analysis8 / 33791 / 337220 / 337

Each cell reads participants affected / participants at risk, as the registry posted them.

Registry data comes from ClinicalTrials.gov. Study results come from studies, not from the registry. How PepBank works

Studies0

Studies that cite this trial.

No study cites this trial.

Eligibility

Who could join, as posted.

Sex
All
Age
from 18 Years
Healthy volunteers
Not accepted
Inclusion and exclusion criteria, as posted
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.

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