AngiosarcomaPhase 2NCT04518124

Propranolol in Angiosarcoma

A Phase 2 study testing Propranolol in people with Angiosarcoma, run by The Netherlands Cancer Institute at 1 site in Netherlands.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record

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Trial summary

This is a window opportunity study of propranolol in patients with angiosarcoma. The aim of this study is to prospectively evaluate the activity of propranolol in the clinical setting as monotherapy, where the neoadjuvant setting provides a good opportunity to rapidly evaluate both the clinical response and… Read more about this study

Who is it for?: Ages 18 years and older
Conditions the study is for: Angiosarcoma
What is being tested?: Propranolol
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 14 participants
Where: 1 siteNetherlands
Study dates: 27 Dec 2019to 30 Oct 2023
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

Histological proof of angiosarcoma
Patients with primary, recurrent and metastasised disease are eligible;
Patients with a window of at least 3 weeks before surgery or systemic therapy;
Age ≥ 18 years;
Able and willing to give written informed consent;
WHO performance status of 0, 1 or 2;

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Evaluable disease according to RECIST 1.1 criteria; radiologic visible disease is not obligated in patients with cutaneous angiosarcoma
Minimal acceptable safety laboratory values
ANC of ≥ 1.5 x 109 /L
Platelet count of ≥ 100 x 109 /L
Hepatic function as defined by serum bilirubin ≤ 1.5 x ULN, ASAT and ALAT ≤ 2.5 x ULN
Renal function as defined by serum creatinine ≤ 1.5 x ULN or creatinine clearance ≥ 50 mL/min (by Cockcroft-Gault formula);
At least one tumor lesion accessible to safely biopsy per clinical judgement of the treating physician

Who cannot join

Contraindication for propranolol therapy, like severe hypotension or bradycardia, sicksinus syndrome, second or third grade heart block, cardiogenic shock, untreated heart failure, severe peripheral vascular disease asthma or other obstructive lung diseases, untreated pheochromocytoma, metabolic acidosis, prolonged fasting.
Current treatment with β-blockade therapy.
Any anticancer treatment within 30 days prior to receiving the first dose of investigational treatment; with the exception of hormonal therapy for breast cancer.
Concurrent treatment with an anticancer therapy: with the exception of hormonal therapy for breast cancer.
Patients with known alcoholism, drug addiction and/or psychiatric of physiological condition which in the opinion of the investigator would impair study compliance;
Evidence of any other disease, neurological or metabolic dysfunction, physical examination finding or laboratory finding giving reasonable suspicion of a disease or condition that contraindicates the use of an investigational drug or puts the patient at high risk for treatment-related complications;
Pregnancy;
Legal incapacity

Trial locations and contacts

1 site in 1 country.

Netherlands1 site

Netherlands Cancer Institute - Antoni van Leeuwenhoek
Amsterdam

Other trials in Netherlands

About this study

Official title: Neoadjuvant Trial on the Efficacy of Propranolol Monotherapy in Cutaneous Angiosarcoma

Read the detailed description

A pilot neoadjuvant window of opportunity study will be performed to explore the activity of propranolol monotherapy in angiosarcoma. The study consists of a single arm. Propranolol will be administred as monotherapy in a dose of 40-80 mg 2-3 times a day, if tolerated. When patients are diagnosed, standard anti-cancer treatment will be scheduled in 6 weeks while propranolol treatment can start immediately after diagnosis and will be continued until the day the standard anti-cancer treatment is started. The duration of treatment will therefore be 3-6 weeks.

Conditions: Angiosarcoma
Being tested: Propranolol
Keywords: Propranolol, Angiosarcoma
Medical subject headings: Hemangiosarcoma

What participants receive

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

PropranololDrug
Propranolol will be administered as monotherapy in a dose of 40-80 mg 2-3 times a day, if tolerated. The study consists of a single arm.

Study groups in NCT04518124
Study group	Role	What they receive
Propranolol	Experimental	Not described Receives: Drug: Propranolol

What is being measured

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

Clinical response
A response is defined as CR, PR, or SD with an improvement in clinical characteristics
Measured: From start to end of treatment: 3-6 weeks

Secondary outcomes (1)

Histological response on propranolol treatment
The histologic response defined as a decrease of >30% of Ki-67 index between pre- and post-propranolol treatment biopsies.
Measured: through study completion, an average of 2 years

Timeline

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

27 Dec 201930 Oct 2023

First posted19 Aug 2020
Study start27 Dec 2019
Primary completion30 Oct 2023
Study completion30 Oct 2023

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Other trials for AngiosarcomaStudies 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: Phase 2
Primary purpose: Treatment
Allocation: Not applicable
Intervention model: Single group
Masking: None (open label)
Enrolment: 14 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT04518124
Sponsor's protocol ID: N19PCA
Status last verified: Nov 2023
First submitted: 9 Jun 2020
Last updated: 22 Nov 2023
Results posted: No
Data monitoring committee: Yes
FDA-regulated drug: No
FDA-regulated device: No

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

See locations

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All Angiosarcoma trials

Study at a glance

From the registry record, last updated by the sponsor on 22 Nov 2023. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: Neoadjuvant Trial on the Efficacy of Propranolol Monotherapy in Cutaneous Angiosarcoma
ClinicalTrials.gov ID: NCT04518124
Acronym / sponsor ID: N19PCA
Conditions: Angiosarcoma
Keywords: Propranolol, Angiosarcoma
Phase: Phase 2
Study type: Interventional
Recruitment status: Completed
Enrolment: 14 participants (actual)
Lead sponsor: The Netherlands Cancer InstituteUniversity, hospital or other
Collaborators: Anticancer Fund, Belgium
Study start: 27 Dec 2019 (actual)
Primary completion: 30 Oct 2023 (actual)
Study completion: 30 Oct 2023 (actual)
First posted: 19 Aug 2020 (actual)
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.

Detailed description

Study design

Primary purpose: Treatment
Allocation: Not applicable
Intervention model: Single group
Masking: None (open label)
Number of arms: 1

Arm	Type	Receives
Propranolol	Experimental	Drug: Propranolol

Who may qualify

Ages: 18 years and older
Sex: All
Healthy volunteers: Not accepted
Age groups: Adult, Older adult

Key inclusion criteria (13 listed)

Histological proof of angiosarcoma
Patients with primary, recurrent and metastasised disease are eligible;
Patients with a window of at least 3 weeks before surgery or systemic therapy;
Age ≥ 18 years;
Able and willing to give written informed consent;

Key exclusion criteria (8 listed)

Contraindication for propranolol therapy, like severe hypotension or bradycardia, sicksinus syndrome, second or third grade heart block, cardiogenic shock, untreated heart failure, severe peripheral vascular disease asthma or other obstructive lung diseases, untreated pheochromocytoma, metabolic acidosis, prolonged fasting.
Current treatment with β-blockade therapy.
Any anticancer treatment within 30 days prior to receiving the first dose of investigational treatment; with the exception of hormonal therapy for breast cancer.
Concurrent treatment with an anticancer therapy: with the exception of hormonal therapy for breast cancer.
Patients with known alcoholism, drug addiction and/or psychiatric of physiological condition which in the opinion of the investigator would impair study compliance;

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
PropranololPropranolol will be administered as monotherapy in a dose of 40-80 mg 2-3 times a day, if tolerated. The study consists of a single arm.	Drug	Propranolol

Primary outcome

Clinical response
Time frame: From start to end of treatment: 3-6 weeks
A response is defined as CR, PR, or SD with an improvement in clinical characteristics

1 secondary outcome

Histological response on propranolol treatment
Time frame: through study completion, an average of 2 years

Results and safety

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 22 Nov 2023.

Related trials for Angiosarcoma

Active, not recruitingPhase 2
Agnostic Therapy in Rare Solid Tumors
Urachal Cancer, Parathyroid Carcinoma
RecruitingPhase 1
A Study of LN-144 or LN-145 in People With Advanced Uveal Melanoma, Undifferentiated Pleomorphic Sarcoma, Dedifferentiated Liposarcoma, or Angiosarcoma
Uveal Melanoma, Melanoma
RecruitingPhase 1
A Study to Evaluate Safety, Tolerability and Preliminary Activity of AGX101 in Participants With Advanced Solid Tumors
Cancer, Advanced Cancer
Active, not recruitingPhase 2
Testing the Addition of Nivolumab to Chemotherapy in Treatment of Soft Tissue Sarcoma
Skin Angiosarcoma, Skin Radiation-Related Angiosarcoma
RecruitingPhase 2
Intratumoral Vusolimogene Oderparepvec (VO) in Combination With Pembrolizumab for Angiosarcoma
Angiosarcoma, Angiosarcoma, Adult

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.

Winan van Houdt, MD PhD principal investigator

Netherlands Cancer Institute - Antoni van Leeuwenhoek

Neeltje Steeghs, MD PhD principal investigator

Netherlands Cancer Institute - Antoni van Leeuwenhoek

1 site in 1 country: see every site and its status.

Questions about this trial

What is this clinical trial studying?

A Phase 2 study testing Propranolol in people with Angiosarcoma, run by The Netherlands Cancer Institute at 1 site in Netherlands.

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 13 inclusion and 8 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: finished, as of the sponsor's last update on 22 Nov 2023. 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 Netherlands. 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 is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

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?

Clinical response (time frame: From start to end of treatment: 3-6 weeks). 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 NCT04518124.

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 22 Nov 2023.