STUDY TO ALLOW ACCESS TO PASIREOTIDE FOR PATIENTS BENEFITING FROM PASIREOTIDE TREATMENT IN A NOVARTIS-SPONSORED STUDY.

An open label, multi-center pasireotide roll-over protocol for patients who have completed a previous Novartissponsored pasireotide study and are judged by the investigator to benefit from continued pasireotide treatment.

Status

Active, not recruiting

Phases

Unknown

Study type

Interventional

Source

REPEC

Registry ID

PER-033-15

Enrollment

Registered

2015-09-21

Start date

2015-10-01

Completion date

Unknown

Last updated

2023-11-13

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

None listed

Interventions

Drug: Pasireotide Pasireotide subcutaneous or Long Acting Release Other Name: SOM230

Eligibility

Sex/Gender

All

Age

18 Years to 99 Years

Inclusion criteria

Inclusion criteria: 1. 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. 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

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. 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). 3. 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.

Countries

Arabia Saudi, Argentina, Australia, Belgium, Brazil, Canada, China, Colombia, France, Germany, Greece, India, Israel, Italy, Korea South, Mexico, Netherlands, Norway, Poland, Romania, Russian Federation, Spain, Sweden, Taiwan, Thailand, Turkey, United Kindgdom, United States

Contacts

Public ContactJoel Sachun

IQVIA RDS Peru S.R.L

joel.sachun@novartis.com200-6516

Outcome results