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

May 18, 2015 updated by: MelCure SA
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 Overview

Status

Terminated

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

5

Phase

  • Early Phase 1

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (ADULT, OLDER_ADULT)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Allocation: RANDOMIZED
  • Interventional Model: SINGLE_GROUP
  • Masking: TRIPLE

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Endothelin receptor B inhibitor BQ-788
Intra-lesion administration of an Endothelin Receptor B inhibitor (BQ-788)
Drug: Endothelin Receptor B inhibitor BQ788
Experimental: PBS
Intra-lesion administration of vehicle
Drug: PBS

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Tumour response by size measurement and histological examination
Time Frame: 3 to14 days
3 to14 days

Secondary Outcome Measures

Outcome Measure
Time Frame
Measuring changes in tumor cell proliferation by histological analyses using Ab staining
Time Frame: 3 to 14 days
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
3 to 14 days
Evaluation of changes in blood vessels formation by histological examination using Ab staining
Time Frame: 3 to 14 days
3 to 14 days
Evaluation of changes in immune cell infiltration by histological examination using Ab staining
Time Frame: 3 to 14 days
3 to 14 days

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

MelCure SA

Collaborators

Universitaire Ziekenhuizen KU Leuven
University of Bern
California Institute of Technology

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

May 1, 2011

Primary Completion (Actual)

May 1, 2012

Study Registration Dates

First Submitted

April 26, 2015

First Submitted That Met QC Criteria

May 10, 2015

First Posted (Estimate)

May 13, 2015

Study Record Updates

Last Update Posted (Estimate)

May 20, 2015

Last Update Submitted That Met QC Criteria

May 18, 2015

Last Verified

May 1, 2015

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • MelCure

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

Clinical Trials on Melanoma

Clinical Trials on Endothelin Receptor B inhibitor BQ788

Search Similar Trials

Sponsors and Collaborators

Medical Conditions

Drug Interventions

CROs by country

CROs in Saudi Arabia

Conditions

Rare Diseases

Drug Interventions

Dietary Supplements

Sponsor/Collaborators

Locations

3
Subscribe