Trial | NCT02442466  Report issue

Title

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

  • Phase

    Early Phase 1

  • Study Type

    Interventional

  • Status

    Terminated

  • Intervention/Treatment

    bq 788 ...

  • Study Participants

    5
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 Started
May 31
2011
Primary Completion
May 31
2012
Last Update
May 20
2015
Estimate

Drug Endothelin Receptor B inhibitor BQ788

Drug PBS

Endothelin receptor B inhibitor BQ-788 Experimental

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

PBS Experimental

Intra-lesion administration of vehicle

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
No Results Posted