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

Phase 4

Completed

Conditions: Acromegaly
Pituitary Tumors
Ectopic ACTH Secreting (EAS) Tumors
Melanoma Negative for bRAF
Cushing's Disease
Neuroendocrine Tumors
Prostate Cancer
Melanoma Negative for nRAS
Dumping Syndrome

Interventions: Drug: Pasireotide
Drug: Pasireotide LAR
Drug: Cabergoline

Registration Number: NCT01794793

Lead Sponsor: RECORDATI GROUP

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.

Recruitment & Eligibility

Status: COMPLETED

Sex: All

Target Recruitment: 337

Inclusion Criteria

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.
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

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.
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.
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.

Study & Design

Study Type: INTERVENTIONAL

Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Pasireotide subcutaneous	Pasireotide	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.
Pasireotide Long Acting Release (LAR)	Pasireotide LAR	10mg, 20mg, 40mg and 60mg. All doses to be taken q28days. Strength is dependent on parent study guidelines.
Pasireotide subcutaneous	Cabergoline	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.

Primary Outcome Measures

Name	Time	Method
Incidence of Adverse Events to Evaluate Long Term Safety Data	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.

Secondary Outcome Measures

Name	Time	Method
Percentage of Patients With Clinical Benefit as Assessed by the Investigator	Baseline up to approximately 10 years	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.

Trial Locations

Locations (9): University of Michigan Comprehensive Cancer Center SC-2
🇺🇸
Ann Arbor, Michigan, United States
Milano Investigative Site
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Milano, MI, Italy
Ximed Research SC - SOM230B2412
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La Jolla, California, United States
Virginia Endocrinology Research SC
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Chesapeake, Virginia, United States
Memorial Sloan-Kettering Cancer Center SC
🇺🇸
New York, New York, United States
Recordati Investigative Site
🇹🇷
Kocaeli, Turkey
Cedars Sinai Medical Center Cedars Sinai 4
🇺🇸
Los Angeles, California, United States
Stanford Universtiy Medical Center Stanford Hospital & Clinics
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Stanford, California, United States
Swedish Cancer Institute Swedish Cancer Institute (SC)
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Seattle, Washington, United States