Phase II Study of Subcutaneous Inj. Depot of Octreotide in Patients With Acromegaly and Neuroendocrine Tumours (NETs)

A Phase II, Open-label, Multicentre, Randomised Study of the Pharmacokinetics, Pharmacodynamics, Efficacy, and Safety of CAM2029 in Patients With Acromegaly and Neuroendocrine Tumours (NETs) Previously Treated With Sandostatin® LAR®

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