Health Condition 1: E220- Acromegaly and pituitary gigantism Health Condition 2: null- ACTH dependent cushings disease
Conditions
Interventions
Intervention1: Pasireotide: Pasireotide
Route:Subcutaneous
Frequency: b.i.d. or t.i.d depending on the parent study guidance
Dose: 600?g
Intervention2: Paseriotide LAR: Pasireotide LAR Route:Intramu
Sponsors
Novartis Healthcare Pvt Ltd
Eligibility
Inclusion criteria
Inclusion criteria: Patient is currently enrolled in a Novartis- sponsored, Oncology CD&MA study receiving pasireotide and has fulfilled all their requirements in the parent study. 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
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. 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. 4. 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 and for 30 days after the final dose of pasireotide. Highly effective contraception is defined as either 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 enrolling). For female patients on the study the vasectomized male partner should be the sole partner for that patient. 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.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| To evaluate long term safety data Ie SAEs and AEs with pasireotide (s.c. and/or LAR) in a Novartis-sponsored study and have fulfilled all required assessments in the parent study.Timepoint: Frequency and severity of AEs/SAEs | — |
Secondary
| Measure | Time frame |
|---|---|
| To evaluate clinical benefit as assessed by the investigator.Timepoint: Proportion of patients with clinical benefit as assessed by the investigator at scheduled visits. | — |
Countries
Argentina, Australia, Belgium, Brazil, Canada, China, France, Germany, Greece, India, Israel, Italy, Mexico, Netherlands, Norway, Poland, Russian Federation, Spain, Switzerland, Taiwan, Thailand, Turkey, United States of America
Contacts
Public ContactDr Manish Mistry
Novartis India Ltd.
Outcome results
None listed