NCT01283542已完成2 期
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
适应症
干预措施
相关药物
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 入组人数
- 20
- 试验地点
- 1
- 主要终点
- Percentage of Participants With Non-functioning Pituitary Adenomas (NFPA) Who Achieve Tumor Volume Reduction of at Least 20% After 24 Weeks (FAS)
研究概览
简要总结
This study assessed pasireotide LAR efficacy on patients with non-functioning pituitary adenomas concerning tumor growth.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Non-functioning pituitary adenoma ≥ 1cm, patients without any previous treatment for the tumor
- •Eastern Cooperative Oncology Group (ECOG) performance status 0 or 1
排除标准
- •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
研究组 & 干预措施
Pasireotide LAR
Experimental
All patients will receive pasireotide LAR (long acting release) 60 mg every 28 ± 3 days for 24 weeks
干预措施: Pasireotide LAR (Drug)
结局指标
主要结局
Percentage of Participants With Non-functioning Pituitary Adenomas (NFPA) Who Achieve Tumor Volume Reduction of at Least 20% After 24 Weeks (FAS)
时间窗: 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.
次要结局
- Percentage of Patients Achieving Tumour Volume Reduction of at Least ≥ 20% in Main Phase (FAS)(baseline to week 4, 12, 24)
- Mean GH and IGF-1 Hormone Levels During Main and Extension Phases (FAS)(Baseline and at weeks 24, 48, 96)
- Percentage of Patients Achieving Tumour Volume Reduction in Main Phase (FAS)(baseline to week 4, 12, 24)
- Percentage of Patients Achieving Tumour Volume Reduction of at Least ≥ 20% in Extension Phase (FAS)(baseline to week 48, 72, 96)
- Mean Cortisol Hormone Levels During Main and Extension Phases (FAS)(Baseline and at weeks 24, 48, 96)
- Mean LH and FSH Hormone Levels During Main and Extension Phases (FAS)(Baseline and at weeks 24, 48, 96)
- Tumor Volume Change From Baseline in Main Phase (FAS)(baseline to week 4, 12, 24)
- Tumor Volume Change From Baseline in Extension Phase (FAS)(baseline to week 48, 72, 96)
- Percentage of Patients Achieving Tumour Volume Reduction in Extension Phase (FAS)(baseline to week 48, 72, 96)
- Percentage of Participants Reporting Absence and Presence of Relevant Disease-related Symptoms (FAS)(Baseline and at weeks 4, 12,24,48,72, 96)
- Mean TSH Hormone Levels During Main and Extension Phases (FAS)(Baseline and at weeks 24, 48, 96)
- Mean Alpha Subunit Levels in Main and Extension Phases (FAS)(Baseline and at weeks 12,24,48,72, 96)
- Tumor Volume Main Phase (FAS)(baseline to week 4, 12, 24)
- Tumor Volume Percent Change From Baseline in Main Phase (FAS)(baseline to week 4, 12, 24)
- Tumor Volume Percent Change From Baseline in Extension Phase (FAS)(baseline to week 48, 72, 96)
- Mean Testosterone and Free T4 Hormone Levels During Main and Extension Phases (FAS)(Baseline and at weeks 24, 48, 96)
- Percentage of Participants With Reduction From Baseline of Alpha Subunit ≥50% in Main and Extension Phases (FAS)(Baseline up to approximately Week 96)
- Tumor Volume in Extension Phase (FAS)(baseline to week 48, 72, 96)
- Mean ACTH and Estradiol Hormone Levels During Main and Extension Phases (FAS)(Baseline and at weeks 24, 48, 96)
研究者
研究点 (1)
Loading locations...
相似试验
终止
2 期
Study of Pasireotide in Patients With Rare Tumors of Neuroendocrine OriginPituitary NeoplasmEctopic ACTH SyndromePancreatic NeoplasmNelson SyndromeNCT00958841Novartis Pharmaceuticals118
已完成
2 期
Study of Pasireotide Long Acting Release (LAR) in Patients With Metastatic Neuroendocrine Tumors (NETs)Neuroendocrine TumorsCarcinoid TumorsNCT01253161H. Lee Moffitt Cancer Center and Research Institute29
终止
2 期
Pasireotide LAR Therapy of Silent Corticotroph Pituitary TumorsACTH-producing Pituitary TumourPituitary TumorNCT02749227Columbia University4
已完成
2 期
Phase II Study Evaluating Efficacy, Safety and Pharmacokinetics of Pasireotide in Patients With Dumping SyndromeDumping SyndromeNCT01637272Novartis Pharmaceuticals43
进行中（未招募）
不适用
Evaluation of the effect of pasireotide LAR administration in the lymphocele prevention after axillary node dissection for breast cancer - SOM 230MedDRA version: 12.1Level: LLTClassification code 10006187Term: Breast cancerBREAST CANCEREUCTR2010-018795-24-FRAlliance pour la recherche en cancérologie