Pharmacokinetics, Efficacy and Safety of an Octreotide Implant in Patients With Carcinoid Syndrome

Endo Pharmaceuticals

Status and phase: Terminated; Phase 2; Phase 1

Conditions: Carcinoid Syndrome

Treatments: Drug: Octreotide

Study type: Interventional

Funder types: Industry

Identifiers

NCT00884715

IP107-002

Details and patient eligibility

About

Evaluate the pharmacokinetics, safety and efficacy of an octreotide implant for the treatment of the symptoms of carcinoid syndrome.

Full description

This study will evaluate a longer acting octreotide formulation. A subcutaneous implant at 2 doses will be evaluated for pharmacodynamics, efficacy and safety for a period of 9 months.

Enrollment: 10 patients

Sex: All

Ages: 18 to 80 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• histologically confirmed tumor
• documented evidence of carcinoid syndrome
• life expectancy of at least 6 months
• previous positive octreotide scan
• received stable doses of octreotide injections
• performance status of 0-2 on the ECOG performance scale

Exclusion criteria

• poorly differentiated or high grade neuroendocrine tumor
• significant cv, hepatic, renal or other disease

Trial design

Primary purpose: Treatment

Allocation: Non-Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

---

10 participants in 2 patient groups

1 implant

Experimental group

Description:

117 mg Octreotide implant

Treatment:

Drug: Octreotide

2 implants

Experimental group

Description:

234 mg Octreotide implant

Treatment:

Drug: Octreotide