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

Camarus

Status and phase: Completed; Phase 2

Conditions: Neuroendocrine Tumors; Acromegaly

Treatments: Drug: octreotide FluidCrystal® injection depot

Study type: Interventional

Funder types: Industry

Identifiers

NCT02299089

HS-12-455

Details and patient eligibility

About

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.

Full 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).

Enrollment: 12 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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12 participants in 4 patient groups

CAM2029 10 mg (NET)

Experimental group

Description:

CAM2029 (octreotide FluidCrystal® injection depot) 10 mg, subcutaneous injection every two weeks

Treatment:

Drug: octreotide FluidCrystal® injection depot

CAM2029 20 mg (NET)

Experimental group

Description:

CAM2029 (octreotide FluidCrystal® injection depot) 20 mg, subcutaneous injection once monthly

Treatment:

Drug: octreotide FluidCrystal® injection depot

CAM2029 10 mg (Acromegaly)

Experimental group

Description:

CAM2029 (octreotide FluidCrystal® injection depot) 10 mg, subcutaneous injection every two weeks

Treatment:

Drug: octreotide FluidCrystal® injection depot

CAM2029 20 mg (Acromegaly)

Experimental group

Description:

CAM2029 (octreotide FluidCrystal® injection depot) 20 mg, subcutaneous injection once monthly

Treatment:

Drug: octreotide FluidCrystal® injection depot