Phase 2 N=9 Targeted Therapy With Lapatinib in Patients With Recurrent Pituitary Tumors Resistant to Standard Therapy
Pituitary Adenomas · Prolactinomas
Primary: Change in Tumor Volume — 10 Percent volume
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Phase 3 N=21 Response to Cabergoline and Pasireotide in Non-functioning Pituitary Adenomas and Resistant Prolactinomas
Non-functioning Pituitary Adenomas · Prolactinomas
Primary: Tumor Volume Changes for NFPA and Prolactin Level Changes for Prolactinoma — 3.8; 29.35 cmˆ3 — p=<0.05
N/A N=43 Peri-Operative Steroid Management in Patients
Pituitary Adenoma · Pituitary Diseases
Primary: Number of Participants With Adrenal Insufficiency — 2; 1 Participants
Phase 2 N=20 Evaluate the Efficacy and Safety of Pasireotide LAR (Long Acting Release) on the Treatment of Patients With Clinically Non-Functioning Pituitary Adenoma.
Non-functioning Pituitary Adenoma
Primary: Percentage of Participants With Non-functioning Pituitary Adenomas (NFPA) Who Achieve Tumor Volume Reduction of at Least 20% After 24 Weeks (FAS) — 16.7 percentage of…
Phase 4 N=41 Surgical Debulking of Pituitary Adenomas
Pituitary Adenoma
Primary: Percentage of Responders (Primary Medical Treatment in Arm 1, Primary Surgical Treatment in Arm 2) — 6.7; 50 percentage of participants
Phase 4 N=15 Anterior Pituitary Hormone Replacement in Traumatic Brain Injury
Growth Hormone Deficiency · Traumatic Brain Injury
Primary: Maximum Oxygen Uptake at Baseline. — 29.0 mL/kg/min
Phase 3 N=108 Lanreotide as Primary Treatment for Acromegalic Patients With Pituitary Gland Macroadenoma
Acromegaly
Primary: Percentage of Patients With Relevant Reduction in Pituitary Tumour Volume (as Measured by MRI) From Baseline Volume (Visit 1) to Week 48 (After 12 Injections at Visit 5)…
Phase 2 N=19 Extension Study to Assess the Safety and Efficacy of Pasireotide in Participants With Cushing's Disease
Cushing Disease
Primary: Percentage of Responders With Mean Urinary Free Cortisol (UFC) Within Normal Limits — 22.2 percentage of responders
Phase 2 N=68 New Imaging Techniques in the Evaluation of Patients With Ectopic Cushing Syndrome
Cushing Syndrome · Endocrine Disease
Primary: Sensitivity of Imaging Modalities for the Detection of ACTH-secreting Non-pituitary Tumor in Patients — 96.3; 77.1; 66.7; 100 percentage of patients
N/A N=40 An Analysis of Presentation and Outcome Following Treatment of Pancreatic Endocrine Neoplasms
Pancreatic Endocrine Neoplasms
Primary: Nonfunctioning and Malignant Pancreatic Endocrine Neoplasms — 28; 12; 22; 18 participants
Phase 2 N=29 Study of Pasireotide Long Acting Release (LAR) in Patients With Metastatic Neuroendocrine Tumors (NETs)
Neuroendocrine Tumors · Carcinoid Tumors
Primary: Progression-free Survival (PFS) at One Year — 11 months
Phase 4 N=20 Endocrine Dysfunction and Growth Hormone Deficiency in Children With Optic Nerve Hypoplasia
Growth Hormone Deficiency · Septo-Optic Dysplasia · Hypopituitarism
Primary: Change in Anthropometric Measures Over Time — 1.97; -0.61; 1.39; 1.22 Z-score
Phase 2 N=122 Impact of Ga-68 DOTATOC PET-CT Imaging in Management of Neuroendocrine Tumors
Neuroendocrine Tumors · Carcinoid Tumors · Neuroblastoma
Primary: Number of Participants With a Change in Treatment Management Based on Findings of the Gallium Ga 68-edotreotide PET/CT Scan — 54; 6; 54 Participants
N/A N=8 Tissue Biomarker for Pegvisomant Action
Acromegaly
Primary: Effect of Pegvisomant on Colon Tissue p53 Expression — 330.57 ng/mL
Phase 2 N=30 An Extension Study to Assess the Long-Term Safety and Efficacy of Pasireotide in Participants With Acromegaly
Acromegaly
Primary: Percentage of Participants With Growth Hormone (GH) and Insulin-like Growth Factor 1 (IGF-1) Observed Response by Dose Class — 20; 28.6; 14.3; 23.1 percentage of…
Phase 3 N=85 Antiproliferative Effect of Octreotide in Patients With Metastasized Neuroendocrine Tumors of the Midgut
Neuroendocrine Tumors
Primary: Time to Tumor Progression Documented by Computed Tomography (CT) or Magnetic Resonance Imaging (MRI) — 14.3; 6.0 Months
N/A N=367 Programme of Acromegaly Screening in Patients With Associated Somatic Disorders
Acromegaly
Primary: Percentage of Participants Diagnosed With Acromegaly — 5.8; 2.4 percentage of participants
Phase 4 N=62 Analgesia Regimens Following Trans-sphenoidal Surgery for Pituitary Tumors
Pituitary Tumor · Pain
Primary: Comparison of Mean Pain Scores Between Two Arms (Measured Every 4 Hours Over 48 Hour) — 1.7; 2.8 0-10 units on a scale
Phase 2 N=33 Efficacy and Safety of Pasireotide LAR (Long-acting Release) in Japanese Patients With Acromegaly or Pituitary Gigantism
Acromegaly · Pituitary Gigantism
Primary: Total-group Response Rate at Month 3 — 18.2 Percentage of participants
Phase 2 N=1,553 Studies of Elevated Parathyroid Activity
Hyperparathyroidism · Hypercalcemia · Parathyroid Neoplasm
Primary: Type of Hyperparathyroidism — 90; 276; 19; 61 Participants
Phase 2 N=18 Ga-DOTATATE PET for Phosphaturic Mesenchymal Tumors in Patients With Tumor Induced Osteomalacia
Osteomalacia
Primary: Number of Participants With Positive Localization of Phosphaturic Mesenchymal Tumors (PMTs) — 15 Participants
N/A N=4 Anti-3-[18F]FACBC Imaging of Parathyroid Adenomas
Parathyroid Disease
Primary: Detection Rate of Parathyroid Adenomas of Anti-3-[18F]FACBC Modality — 80 percentage of adenomas detected
Phase 2 N=15 Lithium for Low-Grade Neuroendocrine Tumors
Neuroendocrine Tumors
Primary: Tumor Response Rate Measured by the Response Evaluation Criteria in Solid Tumors (RECIST) — 0; 0; 0; 8 participants
Phase 2 N=341 Evaluation of 68Gallium-DOTATATE PET/CT for Detecting Neuroendocrine Tumors
Neuroendocrine Tumors · Von Hippel-Lindau Syndrome · Hippel-Lindau Disease
Primary: Number of Lesions Detected Using the 68Gallium-DOTATATE Positron Emission Tomography (PET/Computed Tomography (CT)) Scan — 847 Number of lesions
Phase 2 N=46 AMG 706 and Octreotide in Treating Patients With Low-Grade Neuroendocrine Tumors
Gastrointestinal Carcinoid Tumor · Islet Cell Tumor · Neoplastic Syndrome
Primary: Four-month Progression-free Survival Rate — 78.5 percentage of participants — p=<0.001
Phase 2 N=45 Study Evaluating SOM230 in Patients With Metastatic Carcinoid Tumors
Carcinoid Tumors
Primary: Symptom Control (Diarrhea/Flushing) Using a Patient Symptom Diary — 3; 9; 32 participants
N/A N=28 Growth Hormone Feedback to Insulin-like Growth Factor-I (IGF-1) and Oral Glucose Tolerance Test (OGTT)
Acromegaly · Type 2 Diabetes Mellitus
Primary: Percentage With Growth Hormone (GH) Suppression to < 0.4 ng/ml — 0; 7; 8 Participants
Phase 2 N=10 Weight Loss Study for Patients With Obesity Due to Craniopharyngioma or Other Brain Tumor
Obesity · Overweight · Craniopharyngioma
Primary: Body Weight (kg) — -1.4 kg
Phase 3 N=204 Study of Lanreotide Autogel in Non-functioning Entero-pancreatic Endocrine Tumours
Endocrine Tumors
Primary: Progression-Free Survival (PFS) — NA; 72 Weeks — p=<0.001
Phase 3 N=123 Pasireotide in Patients With Acromegaly Inadequately Controlled With First Generation Somatostatin Analogues
Acromegaly
Primary: Core Phase: Percentage of Participants With Mean GH < 1 g/L and IGF-1 < ULN at Week 36 by Previous Treatment and Overall — 14.6; 13.8; 15.1; 14.6 Percentage of…