Clinical trial · Interventional
Proof of Concept Study With an Endothelin Receptor B Inhibitor (BQ-788) for Human Melanoma
NCT02442466CI-TRIAL-00017972terminatedEarly Phase 1ClinicalTrials.gov clinicaltrialsProvenance
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Why stopped (as posted): Difficulties to recruit on time the required patient population.
Summary
Brief summary (as posted)
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.
Conditions
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Melanoma | Melanoma | ONTOLOGY_EXACT | 0.98 |
Interventions
Interventions (2)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Endothelin Receptor B inhibitor BQ788 | Drug | — | UNRESOLVED |
| PBS | Drug | — | UNRESOLVED |
Design
Arms and outcomes
Arms (2)
- type
- EXPERIMENTAL
- label
- Endothelin receptor B inhibitor BQ-788
- description
- Intra-lesion administration of an Endothelin Receptor B inhibitor (BQ-788)
- interventionNames
- Drug: Endothelin Receptor B inhibitor BQ788
- type
- EXPERIMENTAL
- label
- PBS
- description
- Intra-lesion administration of vehicle
- interventionNames
- Drug: PBS
Primary outcomes (1)
- measure
- Tumour response by size measurement and histological examination
- timeFrame
- 3 to14 days
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
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
References
Publications (6)
- BACKGROUNDLahav R, Ziller C, Dupin E, Le Douarin NM. Endothelin 3 promotes neural crest cell proliferation and mediates a vast increase in melanocyte number in culture. Proc Natl Acad Sci U S A. 1996 Apr 30;93(9):3892-7. doi: 10.1073/pnas.93.9.3892. PMID 8632985
- BACKGROUNDLahav R, Dupin E, Lecoin L, Glavieux C, Champeval D, Ziller C, Le Douarin NM. Endothelin 3 selectively promotes survival and proliferation of neural crest-derived glial and melanocytic precursors in vitro. Proc Natl Acad Sci U S A. 1998 Nov 24;95(24):14214-9. doi: 10.1073/pnas.95.24.14214. PMID 9826680
- BACKGROUNDLahav R, Heffner G, Patterson PH. An endothelin receptor B antagonist inhibits growth and induces cell death in human melanoma cells in vitro and in vivo. Proc Natl Acad Sci U S A. 1999 Sep 28;96(20):11496-500. doi: 10.1073/pnas.96.20.11496. PMID 10500205
- BACKGROUNDLahav R, Suva ML, Rimoldi D, Patterson PH, Stamenkovic I. Endothelin receptor B inhibition triggers apoptosis and enhances angiogenesis in melanomas. Cancer Res. 2004 Dec 15;64(24):8945-53. doi: 10.1158/0008-5472.CAN-04-1510. PMID 15604257
- BACKGROUNDLahav R. Endothelin receptor B is required for the expansion of melanocyte precursors and malignant melanoma. Int J Dev Biol. 2005;49(2-3):173-80. doi: 10.1387/ijdb.041951rl. PMID 15906230
- DERIVEDWouters J, Hunger RE, Garrod T, Dubuis B, Hunziker T, van den Oord JJ, Lahav-le Coutre R. First-in-Human Proof-of-Concept Study: Intralesional Administration of BQ788, an Endothelin Receptor B Antagonist, to Melanoma Skin Metastases. Oncologist. 2015 Oct;20(10):1121-2. doi: 10.1634/theoncologist.2015-0139. Epub 2015 Sep 1. PMID 26330458