Non-functioning Pituitary AdenomaPhase 2Passion INCT01283542
Evaluate the Efficacy and Safety of Pasireotide LAR (Long Acting Release) on the Treatment of Patients With Clinically Non-Functioning Pituitary Adenoma.
A Phase 2 study testing Pasireotide LAR in people with Non-functioning Pituitary Adenoma, run by Novartis Pharmaceuticals at 7 sites in Brazil.
Trial summary
This study assessed pasireotide LAR efficacy on patients with non-functioning pituitary adenomas concerning tumor growth. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Non-functioning Pituitary Adenoma
- What is being tested?
- Pasireotide LAR
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 20 participants
- Where
- 7 sitesBrazil
- Study dates
- 26 Nov 2012to 12 Sep 2017
- Phase
- Phase 2
- 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
- Non-functioning pituitary adenoma ≥ 1cm, patients without any previous treatment for the tumor
- Eastern Cooperative Oncology Group (ECOG) performance status 0 or 1
Who cannot join
- Patients who required a surgical intervention for relief of any sign or symptom associated with tumor compression
- Previous pituitary surgery
- Previous medical treatment for pituitary tumor
- Patients who had received pituitary irradiation within 10 years prior to randomization
- Prolactin (PRL) levels > 100 ng/mL. PRL evaluation should have been performed with diluted samples to ensure "hook effect." was avoided
- Patients who presented prolactinomas, acromegaly or Cushing's disease
- Patients with compression of the optic chiasm causing acute clinically significant visual field defects
Trial locations and contacts
7 sites in 1 country.
7 sites in 1 country
Brazil7 sites
Novartis Investigative Site
Botucatu, São Paulo, 18618-970
Novartis Investigative Site
Curitiba, Paraná, 80030-110
Novartis Investigative Site
Fortaleza, Ceará, 04636-000
Novartis Investigative Site
Joinville, Santa Catarina, 89201260
Novartis Investigative Site
Rio de Janeiro, Rio de Janeiro, 21941-913
Novartis Investigative Site
São Paulo, São Paulo, 04023-900
Novartis Investigative Site
São Paulo, São Paulo, 05403 000
About this study
Official title: An Open-Label, Single Arm, Phase II Study to Evaluate the Efficacy and Safety of Pasireotide LAR on the Treatment of Patients With Clinically Non-Functioning Pituitary Adenoma
This study assessed pasireotide LAR efficacy on patients with non-functioning pituitary adenomas concerning tumor growth.
- Conditions
- Non-functioning Pituitary Adenoma
- Being tested
- Pasireotide LAR
- Keywords
- Non-functioning pituitary adenoma,, pasireotide LAR,, tumor volume
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Pasireotide LARDrug
20 and 40 mg of powder in vials and 2 mL of vehicle in ampoules (for reconstitution) administered as a depot intragluteal IM (intramuscular) injection
| Study group | Role | What they receive |
|---|---|---|
| Pasireotide LAR | Experimental | All patients will receive pasireotide LAR (long acting release) 60 mg every 28 ± 3 days for 24 weeks Receives: Drug: Pasireotide LAR |
What is being measured
The primary outcome is the main question the study is designed to answer.
Percentage of Participants With Non-functioning Pituitary Adenomas (NFPA) Who Achieve Tumor Volume Reduction of at Least 20% After 24 Weeks (FAS)
Tumor volume was evaluated by MRI. MRIs were performed and processed according to the guidelines of the central evaluator's facility.The pituitary adenomas were measured by a neuro-radiologist, using manual tracing together with the imaging analysis software. The largest diameter at any plan determined the maximum diameter of the tumor. A change ≥ 20% in the original volume of the tumor was considered to be clinically significant. Evaluable participants required tumor volume assessment at baseline and at week 24.
Measured: Baseline up to 24 weeks
Secondary outcomes (19)
Tumor Volume Main Phase (FAS)
Tumor volume was evaluated by MRI. MRIs were performed and processed according to the guidelines of the central evaluator's facility. The pituitary adenomas were measured by a neuro-radiologist, using manual tracing together with the imaging analysis software. The largest diameter at any plan determined the maximum diameter of the tumor.
Measured: baseline to week 4, 12, 24
Tumor Volume in Extension Phase (FAS)
Tumor volume was evaluated by MRI. MRIs were performed and processed according to the guidelines of the central evaluator's facility. The pituitary adenomas were measured by a neuro-radiologist, using manual tracing together with the imaging analysis software. The largest diameter at any plan determined the maximum diameter of the tumor.
Measured: baseline to week 48, 72, 96
Tumor Volume Change From Baseline in Main Phase (FAS)
Tumor volume was evaluated by MRI. MRIs were performed and processed according to the guidelines of the central evaluator's facility. The pituitary adenomas were measured by a neuro-radiologist, using manual tracing together with the imaging analysis software. The largest diameter at any plan determined the maximum diameter of the tumor.
Measured: baseline to week 4, 12, 24
Tumor Volume Change From Baseline in Extension Phase (FAS)
Tumor volume was evaluated by MRI. MRIs were performed and processed according to the guidelines of the central evaluator's facility. The pituitary adenomas were measured by a neuro-radiologist, using manual tracing together with the imaging analysis software. The largest diameter at any plan determined the maximum diameter of the tumor.
Measured: baseline to week 48, 72, 96
Tumor Volume Percent Change From Baseline in Main Phase (FAS)
Tumor volume was evaluated by MRI. MRIs were performed and processed according to the guidelines of the central evaluator's facility. The pituitary adenomas were measured by a neuro-radiologist, using manual tracing together with the imaging analysis software. The largest diameter at any plan determined the maximum diameter of the tumor.
Measured: baseline to week 4, 12, 24
Tumor Volume Percent Change From Baseline in Extension Phase (FAS)
Tumor volume was evaluated by MRI. MRIs were performed and processed according to the guidelines of the central evaluator's facility. The pituitary adenomas were measured by a neuro-radiologist, using manual tracing together with the imaging analysis software. The largest diameter at any plan determined the maximum diameter of the tumor.
Measured: baseline to week 48, 72, 96
Percentage of Patients Achieving Tumour Volume Reduction in Main Phase (FAS)
Tumor volume was evaluated by MRI. MRIs were performed and processed according to the guidelines of the central evaluator's facility. The pituitary adenomas were measured by a neuro-radiologist, using manual tracing together with the imaging analysis software. The largest diameter at any plan determined the maximum diameter of the tumor.
Measured: baseline to week 4, 12, 24
Percentage of Patients Achieving Tumour Volume Reduction of at Least ≥ 20% in Main Phase (FAS)
Tumor volume was evaluated by MRI. MRIs were performed and processed according to the guidelines of the central evaluator's facility. The pituitary adenomas were measured by a neuro-radiologist, using manual tracing together with the imaging analysis software. The largest diameter at any plan determined the maximum diameter of the tumor.
Measured: baseline to week 4, 12, 24
Percentage of Patients Achieving Tumour Volume Reduction in Extension Phase (FAS)
Tumor volume was evaluated by MRI. MRIs were performed and processed according to the guidelines of the central evaluator's facility. The pituitary adenomas were measured by a neuro-radiologist, using manual tracing together with the imaging analysis software. The largest diameter at any plan determined the maximum diameter of the tumor.
Measured: baseline to week 48, 72, 96
Percentage of Patients Achieving Tumour Volume Reduction of at Least ≥ 20% in Extension Phase (FAS)
Tumor volume was evaluated by MRI. MRIs were performed and processed according to the guidelines of the central evaluator's facility. The pituitary adenomas were measured by a neuro-radiologist, using manual tracing together with the imaging analysis software. The largest diameter at any plan determined the maximum diameter of the tumor.
Measured: baseline to week 48, 72, 96
Percentage of Participants Reporting Absence and Presence of Relevant Disease-related Symptoms (FAS)
The absence and presence of disease-related symptoms were reported by patients and recorded by the medical staff. Patients classified the symptoms according to a 5-point scale (0 = absent, 1 = mild, 2 = moderate, 3 = severe, 4 = very severe
Measured: Baseline and at weeks 4, 12,24,48,72, 96
Mean GH and IGF-1 Hormone Levels During Main and Extension Phases (FAS)
Hormone levels, including those of GH, IGF-1, and prolactin were evaluated by a central lab
Measured: Baseline and at weeks 24, 48, 96
Mean ACTH and Estradiol Hormone Levels During Main and Extension Phases (FAS)
Hormone levels, including those of growth hormone (GH),insulin-like growth factor 1 (IGF-1), follicle-stimulating hormone (FSH), luteinizing hormone (LH), adrenocorticotropic hormone (ACTH), thyroid-stimulating hormone (TSH), prolactin, cortisol, free thyroxine (free T4), and estradiol (for women) or testosterone (for men), were evaluated by a central lab
Measured: Baseline and at weeks 24, 48, 96
Mean Cortisol Hormone Levels During Main and Extension Phases (FAS)
Hormone levels, including those of GH, IGF-1, follicle-stimulating hormone (FSH), luteinizing hormone (LH), adrenocorticotropic hormone (ACTH), thyroid-stimulating hormone (TSH), prolactin, cortisol, free T4, and estradiol (for women) or testosterone (for men), were evaluated by a central lab
Measured: Baseline and at weeks 24, 48, 96
Mean LH and FSH Hormone Levels During Main and Extension Phases (FAS)
Hormone levels, including those of GH, IGF-1, follicle-stimulating hormone (FSH), luteinizing hormone (LH), adrenocorticotropic hormone (ACTH), thyroid-stimulating hormone (TSH), prolactin, cortisol, free T4, and estradiol (for women) or testosterone (for men), were evaluated by a central lab
Measured: Baseline and at weeks 24, 48, 96
Mean Testosterone and Free T4 Hormone Levels During Main and Extension Phases (FAS)
Hormone levels, including those of GH, IGF-1, follicle-stimulating hormone (FSH), luteinizing hormone (LH), adrenocorticotropic hormone (ACTH), thyroid-stimulating hormone (TSH), prolactin, cortisol, free T4, and estradiol (for women) or testosterone (for men), were evaluated by a central lab
Measured: Baseline and at weeks 24, 48, 96
Mean TSH Hormone Levels During Main and Extension Phases (FAS)
Hormone levels, including those of GH, IGF-1, follicle-stimulating hormone (FSH), luteinizing hormone (LH), adrenocorticotropic hormone (ACTH), thyroid-stimulating hormone (TSH), prolactin, cortisol, free T4, and estradiol (for women) or testosterone (for men), were evaluated by a central lab
Measured: Baseline and at weeks 24, 48, 96
Mean Alpha Subunit Levels in Main and Extension Phases (FAS)
Measured: Baseline and at weeks 12,24,48,72, 96
Percentage of Participants With Reduction From Baseline of Alpha Subunit ≥50% in Main and Extension Phases (FAS)
Alpha subunit levels were determined at a central laboratory.
Measured: Baseline up to approximately Week 96
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 Jan 2011 (estimated)
- Study start26 Nov 2012
- Primary completion12 Sep 2017
- Study completion12 Sep 2017
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 Non-functioning Pituitary AdenomaStudies of the same condition, open and under way.
- More trials run by Novartis PharmaceuticalsThe sponsor's other registered studies.
- 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 2
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 20 participants (actual)
Sponsor and investigators
- Lead sponsor
- Novartis Pharmaceuticals
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Novartis Pharmaceuticals, Study director, Novartis Pharmaceuticals
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01283542
- Sponsor's protocol ID
- CSOM230D2401
- Acronym
- Passion I
- Status last verified
- Apr 2019
- First submitted
- 17 Dec 2010
- Last updated
- 26 Apr 2019
- Results posted
- Yes, on ClinicalTrials.gov
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 26 Apr 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- An Open-Label, Single Arm, Phase II Study to Evaluate the Efficacy and Safety of Pasireotide LAR on the Treatment of Patients With Clinically Non-Functioning Pituitary Adenoma
- ClinicalTrials.gov ID
- NCT01283542
- Acronym / sponsor ID
- Passion I / CSOM230D2401
- Conditions
- Non-functioning Pituitary Adenoma
- Keywords
- Non-functioning pituitary adenoma,, pasireotide LAR,, tumor volume
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 20 participants (actual)
- Lead sponsor
- Novartis PharmaceuticalsIndustry (pharma, biotech, devices)
- Study start
- 26 Nov 2012 (actual)
- Primary completion
- 12 Sep 2017 (actual)
- Study completion
- 12 Sep 2017 (actual)
- First posted
- 26 Jan 2011 (estimated)
- Results
- Posted 26 Apr 2019
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
This study assessed pasireotide LAR efficacy on patients with non-functioning pituitary adenomas concerning tumor growth.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Pasireotide LAR | Experimental | Drug: Pasireotide LARAll patients will receive pasireotide LAR (long acting release) 60 mg every 28 ± 3 days for 24 weeks |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- Non-functioning pituitary adenoma ≥ 1cm, patients without any previous treatment for the tumor
- Eastern Cooperative Oncology Group (ECOG) performance status 0 or 1
Key exclusion criteria (7 listed)
- Patients who required a surgical intervention for relief of any sign or symptom associated with tumor compression
- Previous pituitary surgery
- Previous medical treatment for pituitary tumor
- Patients who had received pituitary irradiation within 10 years prior to randomization
- Prolactin (PRL) levels > 100 ng/mL. PRL evaluation should have been performed with diluted samples to ensure "hook effect." was avoided
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 |
|---|---|---|
| Pasireotide LAR20 and 40 mg of powder in vials and 2 mL of vehicle in ampoules (for reconstitution) administered as a depot intragluteal IM (intramuscular) injection | Drug | Pasireotide LAR |
Primary outcome
Percentage of Participants With Non-functioning Pituitary Adenomas (NFPA) Who Achieve Tumor Volume Reduction of at Least 20% After 24 Weeks (FAS)
Time frame: Baseline up to 24 weeks
Tumor volume was evaluated by MRI. MRIs were performed and processed according to the guidelines of the central evaluator's facility.The pituitary adenomas were measured by a neuro-radiologist, using manual tracing together with the imaging analysis software. The largest diameter at any plan determined the maximum diameter of the tumor. A change ≥ 20% in the original volume of the tumor was considered to be clinically significant. Evaluable participants required tumor volume assessment at baseline and at week 24.
19 secondary outcomes
Tumor Volume Main Phase (FAS)
Time frame: baseline to week 4, 12, 24
Tumor Volume in Extension Phase (FAS)
Time frame: baseline to week 48, 72, 96
Tumor Volume Change From Baseline in Main Phase (FAS)
Time frame: baseline to week 4, 12, 24
Tumor Volume Change From Baseline in Extension Phase (FAS)
Time frame: baseline to week 48, 72, 96
Tumor Volume Percent Change From Baseline in Main Phase (FAS)
Time frame: baseline to week 4, 12, 24
Tumor Volume Percent Change From Baseline in Extension Phase (FAS)
Time frame: baseline to week 48, 72, 96
Percentage of Patients Achieving Tumour Volume Reduction in Main Phase (FAS)
Time frame: baseline to week 4, 12, 24
Percentage of Patients Achieving Tumour Volume Reduction of at Least ≥ 20% in Main Phase (FAS)
Time frame: baseline to week 4, 12, 24
Percentage of Patients Achieving Tumour Volume Reduction in Extension Phase (FAS)
Time frame: baseline to week 48, 72, 96
Percentage of Patients Achieving Tumour Volume Reduction of at Least ≥ 20% in Extension Phase (FAS)
Time frame: baseline to week 48, 72, 96
Percentage of Participants Reporting Absence and Presence of Relevant Disease-related Symptoms (FAS)
Time frame: Baseline and at weeks 4, 12,24,48,72, 96
Mean GH and IGF-1 Hormone Levels During Main and Extension Phases (FAS)
Time frame: Baseline and at weeks 24, 48, 96
Mean ACTH and Estradiol Hormone Levels During Main and Extension Phases (FAS)
Time frame: Baseline and at weeks 24, 48, 96
Mean Cortisol Hormone Levels During Main and Extension Phases (FAS)
Time frame: Baseline and at weeks 24, 48, 96
Mean LH and FSH Hormone Levels During Main and Extension Phases (FAS)
Time frame: Baseline and at weeks 24, 48, 96
Mean Testosterone and Free T4 Hormone Levels During Main and Extension Phases (FAS)
Time frame: Baseline and at weeks 24, 48, 96
Mean TSH Hormone Levels During Main and Extension Phases (FAS)
Time frame: Baseline and at weeks 24, 48, 96
Mean Alpha Subunit Levels in Main and Extension Phases (FAS)
Time frame: Baseline and at weeks 12,24,48,72, 96
Percentage of Participants With Reduction From Baseline of Alpha Subunit ≥50% in Main and Extension Phases (FAS)
Time frame: Baseline up to approximately Week 96
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 26 Apr 2019.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Individual participant dataSharing planned: Undecided
Related trials for Non-functioning Pituitary Adenoma
Active, not recruitingPhase 3
Dopamine Agonist Treatment of Non-functioning Pituitary Adenomas
Pituitary Neoplasms, Adenoma
Not yet recruitingObservational study
Direct Versus Video Laryngoscopy in Patients With Acromegaly
Acromegaly, Nonfunctioning Pituitary Adenoma
Enrolling by invitation
Physical Attendance Versus Telephone or Video Follow-up in Patients With Non-functioning Pituitary Tumors.
Non-Functional Pituitary Adenoma
Recruiting
Individualized Physical Activity or Patients With Non Functioning Pituitary Adenoma
Non-functioning Pituitary Adenoma
Enrolling by invitationPhase 4
Cabergoline in the Management of Nonfunctioning Pituitary Adenoma
Pituitary Adenoma, MRI
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.
Novartis Pharmaceuticals study director
Novartis Pharmaceuticals
7 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Pasireotide LAR in people with Non-functioning Pituitary Adenoma, run by Novartis Pharmaceuticals at 7 sites in Brazil.
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 2 inclusion and 7 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 26 Apr 2019. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 7 sites in Brazil. 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 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
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 26 Apr 2019). 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?
Percentage of Participants With Non-functioning Pituitary Adenomas (NFPA) Who Achieve Tumor Volume Reduction of at Least 20% After 24 Weeks (FAS) (time frame: Baseline up to 24 weeks). 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 26 Apr 2019.