MelanomaEarly Phase 1NCT02442466
Proof of Concept Study With an Endothelin Receptor B Inhibitor (BQ-788) for Human Melanoma
A Early Phase 1 study testing Endothelin Receptor B inhibitor BQ788 and PBS in people with Melanoma, run by MelCure SA.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Melanoma
- What is being tested?
- Endothelin Receptor B inhibitor BQ788 and PBS
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 5 participants
- Where
- No sites listed yet
- Study dates
- May 2011to May 2012
- Phase
- Early Phase 1
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
About this study
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
- Melanoma
- Being tested
- Endothelin Receptor B inhibitor BQ788, PBS
- Medical subject headings
- Melanoma
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Endothelin Receptor B inhibitor BQ788Drug
PBSDrug
| Study group | Role | What they receive |
|---|---|---|
| Endothelin receptor B inhibitor BQ-788 | Experimental | Intra-lesion administration of an Endothelin Receptor B inhibitor (BQ-788) Receives: Drug: Endothelin Receptor B inhibitor BQ788 |
| PBS | Experimental | Intra-lesion administration of vehicle Receives: Drug: PBS |
What is being measured
The primary outcome is the main question the study is designed to answer.
Tumour response by size measurement and histological examination
Measured: 3 to14 days
Secondary outcomes (4)
Measuring changes in tumor cell proliferation by histological analyses using Ab staining
Measured: 3 to 14 days
Evaluation of changes in mRNA as well as protein expression levels of Endothelin Receptor B by PCR and Ab staining
Measured: 3 to 14 days
Evaluation of changes in blood vessels formation by histological examination using Ab staining
Measured: 3 to 14 days
Evaluation of changes in immune cell infiltration by histological examination using Ab staining
Measured: 3 to 14 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 May 2015 (estimated)
- Study startMay 2011
- Primary completionMay 2012
Why it stopped: Difficulties to recruit on time the required patient population.
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (6)Papers the sponsor has linked to this study.
- Other trials for MelanomaStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Early Phase 1
- Allocation
- Randomised
- Intervention model
- Single group
- Masking
- Triple blind
- Who is masked
- Participant, Care provider, Investigator
- Enrolment
- 5 participants (actual)
Sponsor and investigators
- Lead sponsor
- MelCure SA
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- California Institute of Technology, University of Bern, Universitaire Ziekenhuizen KU Leuven
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02442466
- Sponsor's protocol ID
- MelCure
- Status last verified
- May 2015
- First submitted
- 26 Apr 2015
- Last updated
- 20 May 2015
- Results posted
- No
Publications
Lahav 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.
PubMed 8632985Lahav 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.
PubMed 9826680Lahav 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.
PubMed 10500205Lahav 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.
PubMed 15604257Lahav 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.
PubMed 15906230Wouters 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.
PubMed 26330458
Study at a glance
From the registry record, last updated by the sponsor on 20 May 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Proof of Concept Study With an Endothelin Receptor B Inhibitor (BQ-788) for Human Melanoma
- ClinicalTrials.gov ID
- NCT02442466
- Acronym / sponsor ID
- MelCure
- Conditions
- Melanoma
- Phase
- Early Phase 1
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: Difficulties to recruit on time the required patient population.
- Enrolment
- 5 participants (actual)
- Lead sponsor
- MelCure SAIndustry (pharma, biotech, devices)
- Collaborators
- California Institute of Technology, University of Bern, Universitaire Ziekenhuizen KU Leuven
- Study start
- May 2011
- Primary completion
- May 2012 (actual)
- First posted
- 13 May 2015 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Allocation
- Randomised
- Intervention model
- Single group
- Masking
- Triple blind (participant, care provider, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Endothelin receptor B inhibitor BQ-788 | Experimental | Drug: Endothelin Receptor B inhibitor BQ788Intra-lesion administration of an Endothelin Receptor B inhibitor (BQ-788) |
| PBS | Experimental | Drug: PBSIntra-lesion administration of vehicle |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- Written Informed consent
- Histologically confirmed melanoma
- Disease stage III or IV
- At least 2 injectable and surgically removable cutaneous metastasis
- Age > 18 years
Key exclusion criteria (4 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Endothelin Receptor B inhibitor BQ788 | Drug | Endothelin receptor B inhibitor BQ-788 |
| PBS | Drug | PBS |
Primary outcome
Tumour response by size measurement and histological examination
Time frame: 3 to14 days
4 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
Results and safety
The study was stopped early (reason given: Difficulties to recruit on time the required patient population.). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 20 May 2015.
- Background: PubMed 8632985Lahav 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.
- Background: PubMed 9826680Lahav 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.
- Background: PubMed 10500205Lahav 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.
- Background: PubMed 15604257Lahav 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.
- Background: PubMed 15906230Lahav 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.
- Derived from this study: PubMed 26330458Wouters 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
Questions about this trial
What is this clinical trial studying?
A Early Phase 1 study testing Endothelin Receptor B inhibitor BQ788 and PBS in people with Melanoma, run by MelCure SA.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: stopped early, as of the sponsor's last update on 20 May 2015. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Early Phase 1 (sometimes called Phase 0) studies give a very small amount of a treatment to a few people, mainly to see how the body handles it.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study was stopped early (reason given: Difficulties to recruit on time the required patient population.). Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Tumour response by size measurement and histological examination (time frame: 3 to14 days). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT02442466, which also lists 6 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 20 May 2015.