Study to Allow Access to Pasireotide for Patients Benefiting From Pasireotide Treatment in Novartis-sponsored Studies
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|ClinicalTrials.gov Identifier: NCT01794793|
Recruitment Status : Active, not recruiting
First Posted : February 20, 2013
Last Update Posted : November 3, 2020
|Condition or disease||Intervention/treatment||Phase|
|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||Drug: Pasireotide Drug: Cabergoline||Phase 4|
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.
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||413 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|Official Title:||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|
|Actual Study Start Date :||June 10, 2013|
|Estimated Primary Completion Date :||June 9, 2023|
|Estimated Study Completion Date :||June 9, 2023|
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.
Administered subcutaneously in strengths 0.3mg, 0.6mg and 0.9mg. Doses to be taken BID or TID, dependent on parent study guidelines.
Other Name: SOM230; Signifor
Cabergoline tablet 0.5mg or 1.0mg taken by mouth once daily may be combined with subcutaneous formulation of pasireotide for Cushing's Disease or Acromegaly. Dose is dependent on parent study guidelines.
Other Name: dostinex
Experimental: Pasireotide Long Acting Release (LAR)
10mg, 20mg, 40mg and 60mg. All doses to be taken q28days. Strength is dependent on parent study guidelines.
Long Acting Release is administered by monthly injection. The strengths are 10mg, 20mg, 40mg and 60mg. All doses to be taken q28days. Strength is dependent on parent study guidelines.
Other Name: SOM230; Signifor
- Incidence of adverse events to evaluate long term safety data [ Time Frame: 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.
- Percentage of patients with clinical benefit as assessed by the investigator [ Time Frame: Baseline up to approximately 10 years ]Clinical benefit rate as defined by Investigator based on the patients 24 hour Urinary Free Cortisol results.
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01794793
|Study Director:||Recordati||Recordati AG|