Proof of Concept Study With an Endothelin Receptor B Inhibitor (BQ-788) for Human Melanoma

MelCure

Status and phase: Terminated; Early Phase 1

Conditions: Melanoma

Treatments: Drug: PBS; Drug: Endothelin Receptor B inhibitor BQ788

Study type: Interventional

Funder types: Other; Industry

Identifiers

NCT02442466

MelCure

Details and patient eligibility

About

Intra-lesion administration of an Endothelin Receptor B inhibitor (BQ-788) or vehicle was preformed in 5 melanoma patients to have a preliminary analysis of safety, dose, duration and relevance of results observed in pre-clinical studies to the human disease.

Enrollment: 5 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Written Informed consent
• Histologically confirmed melanoma
• Disease stage III or IV
• At least 2 injectable and surgically removable cutaneous metastasis
• Age > 18 years
• Clinically stable medical condition

Exclusion criteria

• Primary ocular melanoma
• Symptomatic intracranial melanoma
• History of severe neurological, cardiovascular, renal, hepatic, endocrinological, respiratory, bone marrow, autoimmune or infectious (HIV) disease
• Pregnancy or lactation

Trial design

5 participants in 2 patient groups

Endothelin receptor B inhibitor BQ-788

Experimental group

Description:

Intra-lesion administration of an Endothelin Receptor B inhibitor (BQ-788)

Treatment:

Drug: Endothelin Receptor B inhibitor BQ788

PBS

Experimental group

Description:

Intra-lesion administration of vehicle

Treatment:

Drug: PBS