Cushing's DiseasePhase 4NCT01794793
Study to Allow Access to Pasireotide for Patients Benefiting From Pasireotide Treatment in Novartis-sponsored Studies
A Phase 4 study testing Pasireotide, Cabergoline and Pasireotide LAR in people with Cushing's Disease and Acromegaly, run by RECORDATI GROUP at 94 sites in 28 countries.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Cushing's Disease, Acromegaly, Neuroendocrine Tumors
- What is being tested?
- Pasireotide, Cabergoline and Pasireotide LAR
- Type of treatment
- Pill or oral medicine, Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 337 participants
- Where
- 94 sitesin 28 countries
- Study dates
- 10 Jun 2013to 25 Jul 2023
- Phase
- Phase 4
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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.
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- 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.
Trial locations and contacts
94 sites in 28 countries.
94 sites in 28 countries
Belgium8 sites
Recordati Investigative Site
Bruges, 8310
Recordati Investigative Site
Brussels, 1090
Recordati Investigative Site
Brussels, 1200
Recordati Investigative Site
Edegem, Antwerpen, 2650
Recordati Investigative Site
Ghent, 9000
Recordati Investigative Site
Leuven, 3000
Recordati Investigative Site
Liège, 4000
Recordati Investigative Site
Wilrijk, 2610
France8 sites
Recordati Investigative Site
Angers, 49933
Recordati Investigative Site
Bron, 69677
Recordati Investigative Site
Le Kremlin-Bicêtre, 94275
Recordati Investigative Site
Lille, 59037
Recordati Investigative Site
Marseille, 13385
Recordati Investigative Site
Pessac, 33604
Recordati Investigative Site
Pierre-Bénite, 69495
Recordati Investigative Site
Toulouse, Cedex 9, 31000
United States7 sites
University of Michigan Comprehensive Cancer Center SC-2
Ann Arbor, Michigan, 48109
Virginia Endocrinology Research SC
Chesapeake, Virginia, 23321
Ximed Research SC - SOM230B2412
La Jolla, California, 92037
Cedars Sinai Medical Center Cedars Sinai 4
Los Angeles, California, 90048
Memorial Sloan-Kettering Cancer Center SC
New York, New York, 10065
Swedish Cancer Institute Swedish Cancer Institute (SC)
Seattle, Washington, 98104
Stanford Universtiy Medical Center Stanford Hospital & Clinics
Stanford, California, 94304
Brazil7 sites
Recordati Investigative Site
Botucatu, São Paulo, 18618-970
Recordati Investigative Site
Curitiba, Paraná, 80030-110
Recordati Investigative Site
Fortaleza, Ceará, 60430 370
Recordati Investigative Site
Joinville, Santa Catarina, 89201260
Recordati Investigative Site
Porto Alegre, Rio Grande do Sul, 90560 030
Recordati Investigative Site
Rio de Janeiro, Rio de Janeiro, 21941-913
Recordati Investigative Site
São Paulo, São Paulo, 05403 000
Germany7 sites
Recordati Investigative Site
Berlin, 13353
Recordati Investigative Site
Hamburg, 20246
Recordati Investigative Site
München, 81377
Recordati Investigative Site
München, 81667
Recordati Investigative Site
Tübingen, 72076
Recordati Investigative Site
Ulm, 89081
Recordati Investigative Site
Würzburg, 97080
Japan6 sites
Recordati Investigative Site
Kobe, Hyōgo, 650-0017
Recordati Investigative Site
Kyoto, Kyoto, 612-8555
Recordati Investigative Site
Maebashi, Gunma, 371 8511
Recordati Investigative Site
Nagoya, Aichi-ken, 460-0001
Recordati Investigative Site
Nankoku, Kochi, 783 8505
Recordati Investigative Site
Suita, Osaka, 565 0871
Turkey (Türkiye)6 sites
Recordati Investigative Site
Ankara, 06500
Recordati Investigative Site
Antalya, 07070
Recordati Investigative Site
Istanbul, TUR, 34098
Recordati Investigative Site
Istanbul, 34890
Recordati Investigative Site
Izmir, 35340
Recordati Investigative Site
Kocaeli, 41380
Italy5 sites
Recordati Investigative Site
Ancona, AN, 60126
Recordati Investigative Site
Genova, GE, 16132
Milano Investigative Site
Milan, MI, 20149
Recordati Investigative Site
Padova, PD, 35128
Recordati Investigative Site
Roma, RM, 00168
Canada4 sites
Recordati Investigative Site
Halifax, Nova Scotia, B3H 1V7
Recordati Investigative Site
London, Ontario, N6A 4L6
Recordati Investigative Site
Montreal, Quebec, H2L 4M1
Recordati Investigative Site
Montreal, Quebec, H2W 1T8
Mexico4 sites
Recordati Investigative Site
Durango, 34270
Recordati Investigative Site
Guadalajara, Jalisco, 44130
Recordati Investigative Site
Mexico City, Mexico City, 14269
Recordati Investigative Site
Mexico City, 07760
Poland4 sites
Recordati Investigative Site
Gdansk, 80 952
Recordati Investigative Site
Poznan, 60-355
Recordati Investigative Site
Warsaw, 04141
Recordati Investigative Site
Wroclaw, 50 367
Russia4 sites
Recordati Investigative Site
Barnaul, 656024
Recordati Investigative Site
Moscow, 123317
Recordati Investigative Site
Saint Petersburg, 197341
Recordati Investigative Site
Tyumen, 625023
Thailand3 sites
Recordati Investigative Site
Bangkok, 10400
Recordati Investigative Site
Bangkok, 10700
Recordati Investigative Site
Songkhla, 90110
Argentina2 sites
Recordati Investigative Site
CABA, Buenos Aires, C1405BCH
Recordati Investigative Site
Mar del Plata, Buenos Aires, B7602CBM
India2 sites
Recordati Investigative Site
Bangalore, Karnataka, 560054
Recordati Investigative Site
Vellore, Tamil Nadu, 632004
Malaysia2 sites
Recordati Investigative Site
Kuala Lumpur, 62502
Recordati Investigative Site
Pulau Pinang, 10990
South Korea2 sites
Recordati Investigative Site
Seoul, 03722
Recordati Investigative Site
Seoul, 06351
Spain2 sites
Recordati Investigative Site
Alicante, Valencia, 03010
Recordati Investigative Site
Barcelona, 08041
Switzerland2 sites
Recordati Investigative Site
Lausanne, 1011
Recordati Investigative Site
Zurich, 8091
About this study
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
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.
Read the 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.
- Conditions
- Cushing's Disease, Acromegaly, Neuroendocrine Tumors, Pituitary Tumors, Ectopic ACTH Secreting (EAS) Tumors, Dumping Syndrome
- Being tested
- Pasireotide, Cabergoline, Pasireotide LAR
- Keywords
- SOM230,, roll-over study, pasireotide LAR, Cushing's disease, Acromegaly, neuroendocrine tumorsNETs, pituitary tumors, Ectopic ACTH secreting, EAS, Dumping Syndrome, metastatic prostate cancer, metastatic melanoma, bRAF, nRAS
- Medical subject headings
- Pituitary ACTH Hypersecretion, Acromegaly, Neuroendocrine Tumors, Pituitary Neoplasms, Neoplasms, Dumping Syndrome, Prostatic Neoplasms, Melanoma
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
PasireotideDrug
Also called SOM230; Signifor
Administered subcutaneously in strengths 0.3mg, 0.6mg and 0.9mg. Doses to be taken BID or TID, dependent on parent study guidelines.
CabergolineDrug
Also called dostinex
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.
Pasireotide LARDrug
Also called SOM230; Signifor
Long Acting Release is administered by a single intramuscular (i.m.) monthly injection. The strengths are 10mg, 20mg, 40mg and 60mg. All doses to be taken q28days. Strength is dependent on parent study guidelines.
| Study group | Role | What they receive |
|---|---|---|
| Pasireotide subcutaneous | Experimental | 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. Receives: Drug: Pasireotide; Drug: Cabergoline |
| Pasireotide Long Acting Release (LAR) | Experimental | 10mg, 20mg, 40mg and 60mg. All doses to be taken q28days. Strength is dependent on parent study guidelines. Receives: Drug: Pasireotide LAR |
What is being measured
The primary outcome is the main question the study is designed to answer.
Incidence of Adverse Events to Evaluate Long Term Safety Data
Collect long term safety data, i.e. SAEs and AEs. SAES will be reviewed and reported as part of the regular pharmacovigilance activities.
Measured: Baseline up to approximately 10 years
Secondary outcomes (1)
Percentage of Patients With Clinical Benefit as Assessed by the Investigator
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.
Measured: Baseline up to approximately 10 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Feb 2013 (estimated)
- Study start10 Jun 2013
- Primary completion25 Jul 2023
- Study completion25 Jul 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for Cushing's DiseaseStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 4
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 337 participants (actual)
Sponsor and investigators
- Lead sponsor
- RECORDATI GROUP
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Recordati, Study director, Recordati AG
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01794793
- Sponsor's protocol ID
- CSOM230B2412
- Status last verified
- Aug 2024
- First submitted
- 15 Feb 2013
- Last updated
- 1 Oct 2024
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 1 Oct 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT01794793
- Acronym / sponsor ID
- CSOM230B2412
- Conditions
- Cushing's Disease, Acromegaly, Neuroendocrine Tumors, Pituitary Tumors, Ectopic ACTH Secreting (EAS) Tumors, Dumping Syndrome
- Keywords
- SOM230,, roll-over study, pasireotide LAR, Cushing's disease, Acromegaly, neuroendocrine tumorsNETs, pituitary tumors, Ectopic ACTH secreting
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 337 participants (actual)
- Lead sponsor
- RECORDATI GROUPIndustry (pharma, biotech, devices)
- Study start
- 10 Jun 2013 (actual)
- Primary completion
- 25 Jul 2023 (actual)
- Study completion
- 25 Jul 2023 (actual)
- First posted
- 20 Feb 2013 (estimated)
- Results
- Posted 28 Aug 2024
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Pasireotide subcutaneous | Experimental | Drug: Pasireotide, Drug: Cabergoline0.3mg, 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) | Experimental | Drug: Pasireotide LAR10mg, 20mg, 40mg and 60mg. All doses to be taken q28days. Strength is dependent on parent study guidelines. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- 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.
Key exclusion criteria (10 listed)
- 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:
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| PasireotideAlso: SOM230; SigniforAdministered subcutaneously in strengths 0.3mg, 0.6mg and 0.9mg. Doses to be taken BID or TID, dependent on parent study guidelines. | Drug | Pasireotide subcutaneous |
| CabergolineAlso: dostinexCabergoline 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. | Drug | Pasireotide subcutaneous |
| Pasireotide LARAlso: SOM230; SigniforLong Acting Release is administered by a single intramuscular (i.m.) monthly injection. The strengths are 10mg, 20mg, 40mg and 60mg. All doses to be taken q28days. Strength is dependent on parent study guidelines. | Drug | Pasireotide Long Acting Release (LAR) |
Primary outcome
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.
1 secondary outcome
Percentage of Patients With Clinical Benefit as Assessed by the Investigator
Time frame: Baseline up to approximately 10 years
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 1 Oct 2024.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Individual participant dataSharing planned: Yes
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Recordati study director
Recordati AG
94 sites in 28 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Pasireotide, Cabergoline and Pasireotide LAR in people with Cushing's Disease and Acromegaly, run by RECORDATI GROUP at 94 sites in 28 countries.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 10 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 1 Oct 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 94 sites in Belgium, France, United States, Brazil, Germany and 23 more countries. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Yes. Results are posted in the registry (first posted 28 Aug 2024). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Incidence of Adverse Events to Evaluate Long Term Safety Data (time frame: Baseline up to approximately 10 years). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 1 Oct 2024.