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

Early Phase 1TerminatedNCT02442466

MelCure SA5 enrolled

Overview

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.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Masking

TRIPLE

Enrollment

Conditions

Melanoma

Interventions

Endothelin Receptor B inhibitor BQ788DRUG

PBSDRUG

Eligibility

Sex: ALLMin age: 18 Years

Medical Language ↔ Plain English

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

Outcomes

Primary Outcomes

Tumour response by size measurement and histological examination

Time frame: 3 to14 days

Secondary Outcomes

Measuring changes in tumor cell proliferation by histological analyses using Ab staining

Time frame: 3 to 14 days

Evaluation of changes in mRNA as well as protein expression levels of Endothelin Receptor B by PCR and Ab staining

Time frame: 3 to 14 days

Evaluation of changes in blood vessels formation by histological examination using Ab staining

Time frame: 3 to 14 days

Evaluation of changes in immune cell infiltration by histological examination using Ab staining

Time frame: 3 to 14 days

Data from ClinicalTrials.gov

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