Conditions: Acromegaly Neuroendocrine Tumors
Keywords: acromegaly neuroendocrine tumour (NET) carcinoid syndrome octreotide Sandostatin LAR
Allocation: RANDOMIZED | Intervention model: PARALLEL
Enrollment: 12
Healthy volunteers: no

Brief 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.

Detailed description:
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).

Arms:
arm 1: CAM2029 (octreotide FluidCrystal® injection depot) 10 mg, subcutaneous injection every two weeks arm 2: CAM2029 (octreotide FluidCrystal® injection depot) 20 mg, subcutaneous injection once monthly arm 3: CAM2029 (octreotide FluidCrystal® injection depot) 10 mg, subcutaneous injection every two weeks arm 4: CAM2029 (octreotide FluidCrystal® injection depot) 20 mg, subcutaneous injection once monthly

Interventions: intervention 1: octreotide FluidCrystal® injection depot
Intervention descriptions: intervention 1: None

Protocol document: