Overview

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

Status:
Terminated
Trial end date:
1969-12-31
Target enrollment:
0
Participant gender:
All
Summary
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.
Phase:
Early Phase 1
Accepts Healthy Volunteers?
No
Details
Lead Sponsor:
MelCure SA
Collaborators:
California Institute of Technology
Universitaire Ziekenhuizen Leuven
University of Bern
Treatments:
BQ 788
Criteria
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