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Metastatic Malignant MelanomaPhase 2NCT01705392

Bevacizumab vs Dacarbazine in Metastatic Melanoma

A Phase 2 study testing Bevacizumab, Propranolol and Enalapril in people with Metastatic Malignant Melanoma and Unresectable Malignant Melanoma, run by Haukeland University Hospital at 1 site in Norway.

Terminated

Stopped early. The study ended before it was planned to and will not resume.

Official record
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Trial summary

The purpose of this study is to compare efficacy of bevacizumab monotherapy with standard chemotherapy (DTIC) in patients with metastatic malignant melanoma. In addition, we want to evaluate the predictive value of a set biomarkers associated with vascular endothelial growth factor (VEGF) dependent angiogenesis. Read more about this study

Who is it for?
Ages 18 years and older
What is being tested?
Bevacizumab, Propranolol and Enalapril
Could I receive a placebo?
No, everyone receives an active treatment
How many people
2 participants
Where
1 siteNorway
Study dates
Jan 2013to 20 Feb 2017
Phase
Phase 2
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

  • Previously treated or untreated, histologically confirmed, metastatic and unresectable melanoma with progressive disease
  • Both BRAF wild type patients as well as BRAF mutated patients are allowed. For BRAF mutated patients, BRAF targeting agents should be considered in first line if otherwise indicated and no contraindications exist.
  • WHO performance status 0-1
  • Age >18 years,
  • Known BRAF mutation
  • Able to undergo outpatient treatment
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  • Patients must have clinically and/or radiographically documented measurable disease according to RECIST.
  • All radiology studies must be performed within 28 days prior to registration (35 days if negative).
  • At least 4 weeks since adjuvant interferon alpha
  • At least 4 weeks since 1st line treatment in case of metastasis
  • Major surgical procedure or significant traumatic injury > 28 days prior to study treatment start. Biopsy or fine needle aspiration > 2 days prior to study treatment start. Central venous line placement must be inserted at least 2 days prior to treatment start.
  • Only patients with irradiated and asymptomatic brain metastases and off dexamethasone are allowed.
  • Hematology: absolute granulocytes > 1.0 x 109/L
  • Platelets > 100 x 109/L
  • Bilirubin < 1.5 x upper normal limit
  • Serum creatinine < 1.5 x upper normal limits
  • LDH < 1.5 x upper normal limit
  • INR < 1.5
  • Absence of any psychological, familial, sociological or geographical condition potentially hampering compliance with the study protocol and follow-up schedule; those conditions should be discussed with the patient before registration in the trial
  • Before patient registration/randomization, written informed consent must be given according to national and local regulations.

Who cannot join

  • No previous DTIC
  • No previous anti-VEGF targeted therapies
  • No pregnant or lactating patients can be included
  • No clinical evidence of coagulopathy
  • No unstable angina pectoris
  • No AV-block II or III without pacemaker
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  • No severe congestive heart failure
  • No untreated phaeochromocytoma
  • No severe bradycardia
  • No severe hypotension
  • No severe impairment of peripheral arterial circulation
  • No uncontrolled cardiac arrhythmia
  • No severe asthma or COPD
  • No uncontrolled diabetes mellitus
  • No Angioneurotic edema
  • No severe Aortic valve stenosis
  • No severe hypertrophic cardiomyopathy
  • No severe renal dysfunction
  • No patients on beta blockers/ ACE inhibitors by inclusion unable/unwilling to discontinue beta blockers/ ACE inhibitors and convert to other classes of antihypertensive drugs
  • No full-dose oral coumarin-derived anticoagulants (INR>1.5) or heparin, thrombolytic agents, or chronic, daily treatment with aspirin (>325 mg/day).
  • No uncontrolled hypertension

Trial locations and contacts

1 site in 1 country.

Norway1 site

  • Haukeland University Hospital

    Bergen, 5021

Other trials in Norway

About this study

Official title: A Randomized Phase II Trial Comparing Bevacizumab Monotherapy With Dacarbazine (DTIC) in Treatment of Malignant Melanoma, Focusing on Angiogenic Markers and Prevention of Hypertension.

The purpose of this study is to compare efficacy of bevacizumab monotherapy with standard chemotherapy (DTIC) in patients with metastatic malignant melanoma. In addition, we want to evaluate the predictive value of a set biomarkers associated with vascular endothelial growth factor (VEGF) dependent angiogenesis. Also, we aim to identify mechanisms causing acquired resistance to treatment with bevacizumab and escape mechanisms caused by other angiogenic growth factors than VEGF. Finally, we want to analyze safety and influence on outcome variables by primary prevention of bevacizumab induced hypertension by low dose beta blockers in comparison with an ACE inhibitor.

Being tested
Bevacizumab, Propranolol, Enalapril, Dacarbazine
Medical subject headings
Melanoma

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • BevacizumabDrug

    Also called Avastin

    Bevacizumab 10 mg/kg q3w

  • PropranololDrug

    Also called Inderal, Inderal retard

    Propranolol 80 mg x 1

  • EnalaprilDrug

    Also called Renitec, Vasotec

    Enalapril 5 mg x 1

  • DacarbazineDrug

    Also called DTIC

    dacarbazine 1000 mg/m2 q3w

Study groups in NCT01705392
Study groupRoleWhat they receive
Bevacizumab plus propranololExperimentalBevacizumab 10mg/kg q2w plus propranolol 80 mg x 1
Receives: Drug: Bevacizumab; Drug: Propranolol
Bevacizumab plus enalaprilExperimentalBevacizumab 10mg/kg q2w plus enalapril 5 mg x 1
Receives: Drug: Bevacizumab; Drug: Enalapril
DacarbazineActive comparatorDacarbazine 1000mg/m2 q3w
Receives: Drug: Dacarbazine

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Progression free survival

    Participants will be followed for the duration of the treatment and as long as they do not progress, an expected average of 6 months

    Measured: Average of 6 months

Secondary outcomes (4)

  1. Response Rates according to RECIST

    Participants will be followed for the duration of the treatment with CT scans for response evaluation every 2 months for an expected average of 6 months.

    Measured: Average 6 months

  2. Disease control rate at 6 months

    Number of patient with complete response, partial response or stable disease at 6 months

    Measured: 6 months

  3. Prevention of hypertension by beta blockers or ACE-inhibitors

    Safety and influence on outcome variables by primary prevention of bevacizumab induced hypertension, by low dose beta blockers (propranolol 80 mg x 1), in comparison with an ACE inhibitor (enalapril 5 mg x 1). Patients will be monitored as during active treatment with anti hypertensive drugs and bevacizumab for an average of 6 months.

    Measured: Average of 6 months

  4. Overall survival

    Participants will be followed until death for overall survival data, an expected average of 12 months

    Measured: Average og 12 months

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted12 Oct 2012 (estimated)
  2. Study startJan 2013
  3. Primary completion20 Feb 2017
  4. Study completion20 Feb 2017

Why it stopped: Lack of financing of the study drug. Not sufficient financial support.

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 2
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Masking
None (open label)
Enrolment
2 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT01705392
Sponsor's protocol ID
2012/910
Status last verified
Feb 2017
First submitted
8 Oct 2012
Last updated
24 Feb 2017
Results posted
No
Data monitoring committee
Yes

Questions about this trial

What is this clinical trial studying?

A Phase 2 study testing Bevacizumab, Propranolol and Enalapril in people with Metastatic Malignant Melanoma and Unresectable Malignant Melanoma, run by Haukeland University Hospital at 1 site in Norway.

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 20 inclusion and 21 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 24 Feb 2017. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in Norway. Whether a site is taking part right now should be confirmed with that site. See every site.

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?

Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.

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: Lack of financing of the study drug. Not sufficient financial support.). 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?

Progression free survival (time frame: Average of 6 months). 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 NCT01705392.

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 24 Feb 2017.

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