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CompletedNCT04518124Updated Nov 22, 2023

Propranolol in Angiosarcoma

A Phase 2 interventional study of Propranolol in Angiosarcoma, sponsored by The Netherlands Cancer Institute. Completed at 1 site in Netherlands. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2023-11-22.

Sponsored by The Netherlands Cancer Institute · Phase 2, Interventional, and Treatment

Phase
Phase 2
Study type
Interventional
Enrollment
14
Allocation
Not applicable
Ages
18 Years and older
Sex
All
01

Study 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 histological response, without a significant delay in anti-cancer treatment.

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.

02

Conditions studied

  • Angiosarcoma

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Keywords

  • Propranolol
  • Angiosarcoma
03

Who can participate

Ages eligible
18 Years and older
Sexes eligible
All
Accepts healthy volunteers
No

Inclusion criteria

  1. Histological proof of angiosarcoma
  2. Patients with primary, recurrent and metastasised disease are eligible;
  3. Patients with a window of at least 3 weeks before surgery or systemic therapy;
  4. Age ≥ 18 years;
  5. Able and willing to give written informed consent;
  6. WHO performance status of 0, 1 or 2;
  7. Evaluable disease according to RECIST 1.1 criteria; radiologic visible disease is not obligated in patients with cutaneous angiosarcoma
  8. Minimal acceptable safety laboratory values
  9. ANC of ≥ 1.5 x 109 /L
  10. Platelet count of ≥ 100 x 109 /L
  11. Hepatic function as defined by serum bilirubin ≤ 1.5 x ULN, ASAT and ALAT ≤ 2.5 x ULN
  12. Renal function as defined by serum creatinine ≤ 1.5 x ULN or creatinine clearance ≥ 50 mL/min (by Cockcroft-Gault formula);
  13. At least one tumor lesion accessible to safely biopsy per clinical judgement of the treating physician

Exclusion criteria

Exclusion Criteria:

  1. 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.
  2. Current treatment with β-blockade therapy.
  3. Any anticancer treatment within 30 days prior to receiving the first dose of investigational treatment; with the exception of hormonal therapy for breast cancer.
  4. Concurrent treatment with an anticancer therapy: with the exception of hormonal therapy for breast cancer.
  5. Patients with known alcoholism, drug addiction and/or psychiatric of physiological condition which in the opinion of the investigator would impair study compliance;
  6. 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;
  7. Pregnancy;
  8. Legal incapacity
04

Study design

Phase
Phase 2
Primary purpose
Treatment
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrollment
14 participants (actual)

Study arms

  • Experimental
    Propranolol

    Drug: Propranolol

Interventions

  • DrugPropranolol

    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.

05

What researchers measure

Primary outcomes

  1. Clinical response

    A response is defined as CR, PR, or SD with an improvement in clinical characteristics

    Time frame: 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.

    Time frame: through study completion, an average of 2 years

06

Study locations

1 site
  • Netherlands Cancer Institute - Antoni van Leeuwenhoek
    Amsterdam, Netherlands
07

Registry details

Key details

Study ID
NCT04518124
Lead sponsor
The Netherlands Cancer Institute
Collaborators
Anticancer Fund, Belgium
Responsible party
Sponsor
First posted
Aug 19, 2020
Start date
Dec 27, 2019
Primary completion
Oct 30, 2023
Completion
Oct 30, 2023
Last update
Nov 22, 2023

Study contacts

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

Oversight

Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

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