A Trial to Assess Efficacy and Safety of Octreotide Subcutaneous Depot in Patients With GEP-NET

Condition(s) studied

Investigational drug(s) / intervention(s)

CAM2029: CAM2029 (octreotide subcutaneous depot) 20 mg will be administered every 2 weeks as a subcutaneous injection

Octreotide LAR: Octreotide LAR 30 mg will be administered every 4 weeks as an intramuscular injection

Lanreotide ATG: Lanreotide ATG 120 mg will be administered every 4 weeks as a deep subcutaneous injection

Study summary

The purpose of this study is to compare the effectiveness and safety of CAM2029 to octreotide LAR or lanreotide ATG in patients with advanced, well-differentiated GEP-NET. Patients who experience progressive disease in the randomized part of the study may proceed to an open-label extension part with intensified treatment with CAM2029.

Eligibility

Primary outcome measure(s)

• Progression-free survival (PFS) as assessed by a Blinded Independent Review Committee (BIRC) — From date of randomization until disease progression or death due to any cause, whichever comes first, assessed up to 48 months
  PFS is defined as time from the date of randomization to the date of the first documented disease progression as per RECIST 1.1 or death due to any cause (whichever occurs first)

Trial sites (86)

+ 46 more sites — see the full list on the official registry below.

More Camurus AB trials in Germany

Other trials for the same condition