Trial · Interventional

CompletedPhase 2Results postedRegistry data

Evaluate the Efficacy and Safety of Pasireotide LAR (Long Acting Release) on the Treatment of Patients With Clinically Non-Functioning Pituitary Adenoma.

Short name Passion I

NCTNCT01283542Other idCSOM230D2401

Open at ClinicalTrials.govAsk about this trial

Overview

Status: Completed
Phase: Phase 2
Enrollment: 20 participants (actual)
Sponsor: Novartis Pharmaceuticals · Industry
Design: Allocation not applicable · Open label (no masking)
Countries: 1 country
Brazil
Start: 26 Nov 2012
Primary completion: 12 Sept 2017
Completion: 12 Sept 2017
First posted: 26 Jan 2011 (estimated)
Last update posted: 26 Apr 2019
Conditions: Non-functioning Pituitary Adenoma

Timeline

1 trial · 1 completed · 1 with posted results

Completed
Ongoing
Not yet recruiting
Stopped
Estimated dates (est.)
Results posted

2012201320142015201620172018

Ph 2
Passion I
NCT01283542
26 Nov 2012 to 12 Sept 2017

Registry summary

Text and fields below are the sponsor's entries at ClinicalTrials.gov, shown as posted.

This study assessed pasireotide LAR efficacy on patients with non-functioning pituitary adenomas concerning tumor growth.

Interventions

Pasireotide LARDrug

Arms1

Experimental
Pasireotide LAR
All patients will receive pasireotide LAR (long acting release) 60 mg every 28 ± 3 days for 24 weeks

Primary outcomes1

Outcomes the sponsor listed as primary.

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
Registry description
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.

Secondary outcomes(19)

Tumor Volume Main Phase (FAS)
Time frame · baseline to week 4, 12, 24
Registry description
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.
Tumor Volume in Extension Phase (FAS)
Time frame · baseline to week 48, 72, 96
Registry description
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.
Tumor Volume Change From Baseline in Main Phase (FAS)
Time frame · baseline to week 4, 12, 24
Registry description
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.
Tumor Volume Change From Baseline in Extension Phase (FAS)
Time frame · baseline to week 48, 72, 96
Registry description
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.
Tumor Volume Percent Change From Baseline in Main Phase (FAS)
Time frame · baseline to week 4, 12, 24
Registry description
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.
Tumor Volume Percent Change From Baseline in Extension Phase (FAS)
Time frame · baseline to week 48, 72, 96
Registry description
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.
Percentage of Patients Achieving Tumour Volume Reduction in Main Phase (FAS)
Time frame · baseline to week 4, 12, 24
Registry description
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.
Percentage of Patients Achieving Tumour Volume Reduction of at Least ≥ 20% in Main Phase (FAS)
Time frame · baseline to week 4, 12, 24
Registry description
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.
Percentage of Patients Achieving Tumour Volume Reduction in Extension Phase (FAS)
Time frame · baseline to week 48, 72, 96
Registry description
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.
Percentage of Patients Achieving Tumour Volume Reduction of at Least ≥ 20% in Extension Phase (FAS)
Time frame · baseline to week 48, 72, 96
Registry description
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.
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
Registry description
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
Mean GH and IGF-1 Hormone Levels During Main and Extension Phases (FAS)
Time frame · Baseline and at weeks 24, 48, 96
Registry description
Hormone levels, including those of GH, IGF-1, and prolactin were evaluated by a central lab
Mean ACTH and Estradiol Hormone Levels During Main and Extension Phases (FAS)
Time frame · Baseline and at weeks 24, 48, 96
Registry description
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
Mean Cortisol Hormone Levels During Main and Extension Phases (FAS)
Time frame · Baseline and at weeks 24, 48, 96
Registry description
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
Mean LH and FSH Hormone Levels During Main and Extension Phases (FAS)
Time frame · Baseline and at weeks 24, 48, 96
Registry description
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
Mean Testosterone and Free T4 Hormone Levels During Main and Extension Phases (FAS)
Time frame · Baseline and at weeks 24, 48, 96
Registry description
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
Mean TSH Hormone Levels During Main and Extension Phases (FAS)
Time frame · Baseline and at weeks 24, 48, 96
Registry description
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
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
Registry description
Alpha subunit levels were determined at a central laboratory.

Posted results

Values are shown as posted at ClinicalTrials.gov, with their units. PepBank has not converted, pooled or compared them.

Primary outcome results

Primary outcomeNumber· Baseline up to 24 weeks

Percentage of Participants With Non-functioning Pituitary Adenomas (NFPA) Who Achieve Tumor Volume Reduction of at Least 20% After 24 Weeks (FAS)

Group	Value (percentage of participants)
Pasireotide LAR	16.7

Secondary and other outcome results(7)

Secondary outcomeMean· baseline to week 4, 12, 24

Tumor Volume Main Phase (FAS)

Group	Value (cm^3)	Spread
Pasireotide LAR	2.97	2.53

Secondary outcomeMean· baseline to week 48, 72, 96

Tumor Volume in Extension Phase (FAS)

Group	Value (cm^3)	Spread
Pasireotide LAR	3.57	3.25

Secondary outcomeMean· baseline to week 4, 12, 24

Tumor Volume Change From Baseline in Main Phase (FAS)

Group	Value (cm^3)
Pasireotide LAR	1.25

Secondary outcomeMean· baseline to week 48, 72, 96

Tumor Volume Change From Baseline in Extension Phase (FAS)

Group	Value (cm^3)	Spread
Pasireotide LAR	0.53	2.19

Secondary outcomeMean· baseline to week 4, 12, 24

Tumor Volume Percent Change From Baseline in Main Phase (FAS)

Group	Value (percent change)
Pasireotide LAR	36.92

Secondary outcomeMean· baseline to week 48, 72, 96

Tumor Volume Percent Change From Baseline in Extension Phase (FAS)

Group	Value (percent change)	Spread
Pasireotide LAR	14.83	67.28

Secondary outcomeNumber· baseline to week 4, 12, 24

Percentage of Patients Achieving Tumour Volume Reduction in Main Phase (FAS)

Group	Value (percentage of patients)
Pasireotide LAR	47.4

Adverse events, as posted

Adverse events as posted: participants affected out of participants at risk, by group
Group	Deaths	Serious events	Other events
Pasireotide LARAll patients will receive pasireotide LAR (long acting release) 60 mg every 28 ± 3 days for 24 weeks	0 / 20	2 / 20	17 / 20

Each cell reads participants affected / participants at risk, as the registry posted them.

Registry data comes from ClinicalTrials.gov. Study results come from studies, not from the registry. How PepBank works

Studies0

Studies that cite this trial.

No study cites this trial.

Eligibility

Who could join, as posted.

Sex: All
Age: from 18 Years
Healthy volunteers: Not accepted

Inclusion and exclusion criteria, as posted

Inclusion Criteria: * Non-functioning pituitary adenoma ≥ 1cm, patients without any previous treatment for the tumor * Eastern Cooperative Oncology Group (ECOG) performance status 0 or 1 Exclusion Criteria: * 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

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