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Completed

NCT Number: NCT01283542

Evaluate the Efficacy and Safety of Pasireotide LAR (Long Acting Release) 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.

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Key information

Conditions

Non-functioning Pituitary Adenoma

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 2

Primary location

Novartis Investigative Site, Fortaleza, Ceará, Brazil

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Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

pasireotide LAR

Drug

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

Primary outcomes

  1. 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.

Secondary outcomes

  1. Tumor Volume Main Phase (FAS)

    Time frame: baseline to week 4, 12, 24

    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.

  2. Tumor Volume in Extension Phase (FAS)

    Time frame: baseline to week 48, 72, 96

    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.

  3. Tumor Volume Change From Baseline in Main Phase (FAS)

    Time frame: baseline to week 4, 12, 24

    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.

  4. Tumor Volume Change From Baseline in Extension Phase (FAS)

    Time frame: baseline to week 48, 72, 96

    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.

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

    Time frame: baseline to week 4, 12, 24

    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.

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

    Time frame: baseline to week 48, 72, 96

    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.

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

    Time frame: baseline to week 4, 12, 24

    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.

  8. Percentage of Patients Achieving Tumour Volume Reduction of at Least ≥ 20% in Main Phase (FAS)

    Time frame: baseline to week 4, 12, 24

    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.

  9. Percentage of Patients Achieving Tumour Volume Reduction in Extension Phase (FAS)

    Time frame: baseline to week 48, 72, 96

    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.

  10. Percentage of Patients Achieving Tumour Volume Reduction of at Least ≥ 20% in Extension Phase (FAS)

    Time frame: baseline to week 48, 72, 96

    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.

  11. 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

    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

  12. Mean GH and IGF-1 Hormone Levels During Main and Extension Phases (FAS)

    Time frame: Baseline and at weeks 24, 48, 96

    Hormone levels, including those of GH, IGF-1, and prolactin were evaluated by a central lab

  13. Mean ACTH and Estradiol Hormone Levels During Main and Extension Phases (FAS)

    Time frame: Baseline and at weeks 24, 48, 96

    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

  14. Mean Cortisol Hormone Levels During Main and Extension Phases (FAS)

    Time frame: Baseline and at weeks 24, 48, 96

    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

  15. Mean LH and FSH Hormone Levels During Main and Extension Phases (FAS)

    Time frame: Baseline and at weeks 24, 48, 96

    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

  16. Mean Testosterone and Free T4 Hormone Levels During Main and Extension Phases (FAS)

    Time frame: Baseline and at weeks 24, 48, 96

    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

  17. Mean TSH Hormone Levels During Main and Extension Phases (FAS)

    Time frame: Baseline and at weeks 24, 48, 96

    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

  18. Mean Alpha Subunit Levels in Main and Extension Phases (FAS)

    Time frame: Baseline and at weeks 12,24,48,72, 96

  19. 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

    Alpha subunit levels were determined at a central laboratory.

Sponsors and collaborators

Lead sponsor

Novartis Pharmaceuticals

Industry

Registry information

Official study 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

Acronym: Passion I

Important dates

Study start
2012
Primary completion
2017
Study completion
2017
First posted
Jan 26, 2011
Registry last updated
Apr 26, 2019

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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