Find trials
Consejos para buscar

A Study to Assess Effectiveness and Safety of Octreotide Subcutaneous Depot in Patients With Acromegaly

Overview

Información sobre este estudio

The purpose of this study is to assess the effectiveness and safety of CAM2029 in patients with acromegaly. Patients will be randomized to either CAM2029 or placebo administered subcutaneously once monthly during 6 months.

Elegibilidad para la participación

Los requisitos de elegibilidad de los participantes incluyen la edad, el sexo, el tipo y el estadio de la enfermedad, y los problemas de salud o tratamientos previos. Las pautas difieren de un estudio a otro e identifican quiénes pueden o no pueden participar. No hay garantía de que cada persona elegible que desee participar en un ensayo se inscribirá. Comunícate con el equipo del estudio para analizar la elegibilidad del estudio y la posible participación.

Inclusion Criteria: 

  • Male or female patients.
  • Age ≥ 18 years old at screening.
  • Able to provide written informed consent to participate in the trial prior to any trial related procedures are performed.
  • Diagnosis of acromegaly by historical evidence of (persistent or recurrent) acromegaly.
  • Treatment with a stable dose of octreotide LAR or lanreotide ATG for at least 3 months as monotherapy prior to screening.
  • IGF-1 levels ≤ 1 x ULN at screening.
  • Adequate liver, pancreatic, renal and bone marrow functions.
  • Normal ECG.

Exclusion Criteria:

  • GH ≥ 2.5 μg/L at screening (cycle).
  • Have received medical treatment for acromegaly with pasireotide (within 6 months prior to screening), pegvisomant (within 3 months prior to screening), dopamine agonists (within 3 months prior to screening) or other investigational agents (within 30 days or 5 half-lives prior to screening [whichever is longer].
  • Patients who usually take octreotide LAR or lanreotide ATG less frequently than every 4 weeks (e.g., every 6 weeks or 8 weeks).
  • Patients with compression of the optic chiasm causing any visual field defect for whom surgical intervention is indicated.
  • Patients who have undergone major surgery/surgical therapy for any cause within 1 month from screening.
  • Patients who have undergone pituitary surgery within 6 months prior to screening.
  • Patients who have received prior pituitary irradiation.
  • Patients with poorly controlled diabetes mellitus (hemoglobin A1c > 8.0%)

Sedes participantes de Mayo Clinic

Los estatus de los estudios cambian con frecuencia. Comunícate con el equipo del estudio para obtener la información más actualizada acerca de la posibilidad de participar.

Sede de Mayo Clinic Estatus

Rochester, Minn.

Investigador principal de Mayo Clinic

Irina Bancos, M.D.

Cerrado para la inscripción

More information

Publicaciones

Publications are currently not available

Otros temas en investigación

.
CLS-20472288

Mayo Clinic Footer