Propranolol in Angiosarcoma

NCT04518124 | Completed Phase 2 DMC

• 1 other identifier: N19PCA
• Study Type: interventional
• Target: 14
• Locations: 1 country
• Sites: 1

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, 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.

Conditions

Angiosarcoma

Keywords

Propranolol; Angiosarcoma

Outcome Measures

Primary Outcomes (1)

• Clinical response

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

  From start to end of treatment: 3-6 weeks

Secondary Outcomes (1)

• Histological response on propranolol treatment

  through study completion, an average of 2 years

Study Arms (1)

Propranolol

EXPERIMENTAL

Drug: Propranolol

Interventions

Propranolol DRUG

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.

Propranolol

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• The Netherlands Cancer Institute: lead
• Anticancer Fund, Belgium: collaborator

Study Sites (1)

Netherlands Cancer Institute - Antoni van Leeuwenhoek

Amsterdam, Netherlands

Location

MeSH Terms

Conditions

Hemangiosarcoma

Interventions

Propranolol

Condition Hierarchy (Ancestors)

Sarcoma; Neoplasms, Connective and Soft Tissue; Neoplasms by Histologic Type; Neoplasms; Neoplasms, Vascular Tissue

Intervention Hierarchy (Ancestors)

Phenoxypropanolamines; Propanolamines; Amino Alcohols; Alcohols; Organic Chemicals; Propanols; Amines; Naphthalenes; Polycyclic Aromatic Hydrocarbons; Hydrocarbons, Aromatic; Hydrocarbons, Cyclic; Hydrocarbons; Polycyclic Compounds

Study Officials

• Winan van Houdt, MD PhD

  Netherlands Cancer Institute - Antoni van Leeuwenhoek

  PRINCIPAL INVESTIGATOR

• Neeltje Steeghs, MD PhD

  Netherlands Cancer Institute - Antoni van Leeuwenhoek

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: June 9, 2020
• First Posted: August 19, 2020
• Study Start: December 27, 2019
• Primary Completion: October 30, 2023
• Study Completion: October 30, 2023
• Last Updated: November 22, 2023

Record last verified: 2023-11

Locations

NL (1)