This is 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.
- Conditions
- Health Condition 1: E220- Acromegaly and pituitary gigantismHealth Condition 2: null- ACTH dependent cushings disease
- Registration Number
- CTRI/2015/06/005880
- Lead Sponsor
- ovartis Healthcare Pvt Ltd
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Closed to Recruitment of Participants
- Sex
- Not specified
- Target Recruitment
- 0
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.
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.
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method To evaluate long term safety <br/ ><br>data Ie SAEs and AEs with pasireotide (s.c. and/or <br/ ><br>LAR) in a Novartis-sponsored study and have fulfilled <br/ ><br>all required assessments in the parent study.Timepoint: Frequency and severity of <br/ ><br>AEs/SAEs
- Secondary Outcome Measures
Name Time Method To evaluate clinical benefit as assessed by the investigator.Timepoint: Proportion of patients with <br/ ><br>clinical benefit as assessed by the investigator at scheduled <br/ ><br>visits.