TriangleNCT01283542 · REGISTRY CONDITION SEARCH
Evaluate the Efficacy and Safety of Pasireotide LAR (Long Acting Release) on the Treatment of Patients With Clinically Non-Functioning Pituitary Adenoma.
Found through the registry condition index, not selected as a treatment recommendation. This discovery collection was restricted to studies with posted results.
- Phase
- PHASE2
- Status at capture
- COMPLETED
- Registry last update
- 2019-04-26
This study assessed pasireotide LAR efficacy on patients with non-functioning pituitary adenomas concerning tumor growth.
Open the original ClinicalTrials.gov record → · Download preserved record
What did the study report?
Outcomes, safety and baseline populations are separate source sections. Quality-of-life measures appear under their original outcome titles.
Participant flow
Baseline characteristics
Percentage of Participants With Non-functioning Pituitary Adenomas (NFPA) Who Achieve Tumor Volume Reduction of at Least 20% After 24 Weeks (FAS)
Tumor Volume Main Phase (FAS)
Tumor Volume in Extension Phase (FAS)
Tumor Volume Change From Baseline in Main Phase (FAS)
Tumor Volume Change From Baseline in Extension Phase (FAS)
Tumor Volume Percent Change From Baseline in Main Phase (FAS)
Tumor Volume Percent Change From Baseline in Extension Phase (FAS)
Percentage of Patients Achieving Tumour Volume Reduction in Main Phase (FAS)
Percentage of Patients Achieving Tumour Volume Reduction of at Least ≥ 20% in Main Phase (FAS)
Percentage of Patients Achieving Tumour Volume Reduction in Extension Phase (FAS)
Percentage of Patients Achieving Tumour Volume Reduction of at Least ≥ 20% in Extension Phase (FAS)
Percentage of Participants Reporting Absence and Presence of Relevant Disease-related Symptoms (FAS)
Mean GH and IGF-1 Hormone Levels During Main and Extension Phases (FAS)
Mean ACTH and Estradiol Hormone Levels During Main and Extension Phases (FAS)
Mean Cortisol Hormone Levels During Main and Extension Phases (FAS)
Mean LH and FSH Hormone Levels During Main and Extension Phases (FAS)
Mean Testosterone and Free T4 Hormone Levels During Main and Extension Phases (FAS)
Mean TSH Hormone Levels During Main and Extension Phases (FAS)
Mean Alpha Subunit Levels in Main and Extension Phases (FAS)
Percentage of Participants With Reduction From Baseline of Alpha Subunit ≥50% in Main and Extension Phases (FAS)
Adverse events
Limitations, agreements, and source contact
Who could take part
- eligibility Criteria
- 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
- healthy Volunteers
- false
- minimum Age
- 18 Years
- sex
- ALL
- std Ages
- ADULT
- OLDER_ADULT
Treatment arms and interventions
- arm Groups
- description
- All patients will receive pasireotide LAR (long acting release) 60 mg every 28 ± 3 days for 24 weeks
- intervention Names
- Drug: Pasireotide LAR
- label
- Pasireotide LAR
- type
- EXPERIMENTAL
- interventions
- arm Group Labels
- Pasireotide LAR
- description
- 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
- name
- Pasireotide LAR
- type
- DRUG
Study design
- allocation
- NA
- intervention Model
- SINGLE_GROUP
- masking Info
- masking
- NONE
- primary Purpose
- TREATMENT
Enrollment
- count
- 20
- type
- ACTUAL
Registered outcome plans (not posted results)
- primary Outcomes
- 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.
- 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
- secondary Outcomes
- 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.
- measure
- Tumor Volume Main Phase (FAS)
- time Frame
- baseline to week 4, 12, 24
- 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.
- measure
- Tumor Volume in Extension Phase (FAS)
- time Frame
- baseline to week 48, 72, 96
- 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.
- measure
- Tumor Volume Change From Baseline in Main Phase (FAS)
- time Frame
- baseline to week 4, 12, 24
- 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.
- measure
- Tumor Volume Change From Baseline in Extension Phase (FAS)
- time Frame
- baseline to week 48, 72, 96
- 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.
- measure
- Tumor Volume Percent Change From Baseline in Main Phase (FAS)
- time Frame
- baseline to week 4, 12, 24
- 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.
- measure
- Tumor Volume Percent Change From Baseline in Extension Phase (FAS)
- time Frame
- baseline to week 48, 72, 96
- 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.
- measure
- Percentage of Patients Achieving Tumour Volume Reduction in Main Phase (FAS)
- time Frame
- baseline to week 4, 12, 24
- 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.
- measure
- Percentage of Patients Achieving Tumour Volume Reduction of at Least ≥ 20% in Main Phase (FAS)
- time Frame
- baseline to week 4, 12, 24
- 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.
- measure
- Percentage of Patients Achieving Tumour Volume Reduction in Extension Phase (FAS)
- time Frame
- baseline to week 48, 72, 96
- 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.
- measure
- Percentage of Patients Achieving Tumour Volume Reduction of at Least ≥ 20% in Extension Phase (FAS)
- time Frame
- baseline to week 48, 72, 96
- 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
- measure
- 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
- description
- Hormone levels, including those of GH, IGF-1, and prolactin were evaluated by a central lab
- measure
- Mean GH and IGF-1 Hormone Levels During Main and Extension Phases (FAS)
- time Frame
- Baseline and at weeks 24, 48, 96
Full study description
- brief Summary
- This study assessed pasireotide LAR efficacy on patients with non-functioning pituitary adenomas concerning tumor growth.
Source references
Source notices and limitations
Discovery and provenance
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Preserved source evidence · Not medical advice