Phase II Study of Subcutaneous Inj. Depot of Octreotide in Patients With Acromegaly and Neuroendocrine Tumours (NETs)
Phase II Study of Subcutaneous Inj. Depot of Octreotide in Patients With Acromegaly and Neuroendocrine Tumours (NETs)
This is a Phase II, open-label multicentre, randomised study to assess the PK, PD, efficacy,
 and safety of two dosing regimens of CAM2029 in adult patients with acromegaly or a
 functional, well-differentiated NET, with carcinoid symptoms.
This is a Phase II, open-label multicentre, randomised study to assess the PK, PD, efficacy,
 and safety of two dosing regimens of CAM2029 in adult patients with acromegaly or a
 functional, well-differentiated NET, with carcinoid symptoms, treated for at least 2 months
 with Sandostatin LAR at doses of 10 mg, 20 mg, or 30 mg before the start of the Sandostatin
 LAR Last Dose Assessment Phase (Day -28).
Inclusion Criteria:

 Acromegaly:

 -  Male or female patients ≥18 years of age

 -  Acromegaly currently treated with Sandostatin LAR

 NET:

 -  Male or female patients ≥18 years of age

 -  Functional, well-differentiated (Grade 1 or Grade 2) NET with symptoms of carcinoid
 syndrome (number of bowel movements and/or flushing)

 -  Currently treated with Sandostatin LAR for symptom control

 Exclusion Criteria:

 Acromegaly:

 -  Inadequate bone marrow function

 -  Abnormal coagulation or chronic treatment with warfarin or coumarin derivates

 -  Impaired liver, cardiac and/or renal function

 -  Known gallbladder, bile duct disease or pancreatitis

 -  Diabetes with poorly controlled blood glucose levels despite adequate therapy

 -  Hypothyroidisms not adequately treated

 NET:

 -  Poorly differentiated neuroendocrine carcinoma, high-grade neuroendocrine carcinoma,
 adenocarcinoid, pancreatic islet cell carcinoma, insulinoma, glucagonoma, gastrinoma,
 goblet cell carcinoid, typical and atypical lung carcinoids, large cell neuroendocrine
 carcinoma and small cell carcinoma

 -  Carcinoid syndrome refractory to treatment with conventional doses of somatostatin
 analogues (SSAs)

 -  Inadequate bone marrow function

 -  Abnormal coagulation or chronic treatment with warfarin or coumarin derivates

 -  Impaired liver, cardiac and/or renal function

 -  Known gallbladder, bile duct disease or pancreatitis

 -  Short-bowel syndrome

 -  Diabetics with poorly controlled blood glucose levels despite adequate therapy

 -  Hypothyroidism, not adequately treated