Status:
COMPLETED
Propranolol in Angiosarcoma
Lead Sponsor:
The Netherlands Cancer Institute
Collaborating Sponsors:
Anticancer Fund, Belgium
Conditions:
Angiosarcoma
Eligibility:
All Genders
18+ years
Phase:
PHASE2
Brief 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, ...
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 administre...
Eligibility Criteria
Inclusion
- 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;
- 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
Exclusion
- 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
Key Trial Info
Start Date :
December 27 2019
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
October 30 2023
Estimated Enrollment :
14 Patients enrolled
Trial Details
Trial ID
NCT04518124
Start Date
December 27 2019
End Date
October 30 2023
Last Update
November 22 2023
Active Locations (1)
Enter a location and click search to find clinical trials sorted by distance.
1
Netherlands Cancer Institute - Antoni van Leeuwenhoek
Amsterdam, Netherlands