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

Launched by CAMURUS AB · Nov 21, 2014

Keywords

ClinConnect Summary

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).

Gender

ALL

Eligibility criteria

• 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