Dose-Finding of Propranolol in combination with metronomic fixed oral cyclophosphamide based on Bivariate efficacy-tolerability outcome in patients with locally advanced or metastatic angiosarcoma : A collaborative and innovative phase I-II sequential trial by the French Sarcoma Group (GSF/GETO)

• Conditions: Patients presenting angiosarcomas disease; Therapeutic area: Diseases [C] - Cancer [C04]

• Registration Number: EUCTR2015-005177-21-FR
• Lead Sponsor: Assistance Publique Hôpitaux de MARSEILLE

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2016-03-14
• Last Update Posted: 11 April 2016

Recruitment & Eligibility

• Status: Authorised-recruitment may be ongoing or finished
• Sex: All
• Target Recruitment: Not specified

Inclusion Criteria

•Man or woman 18 years old or over and a World Health Organization performance status score = 2 PS;
-Adolescents > 15 years with body surface > 1.6 m2

•Subject with an Histologically proven angiosarcoma, reviewed by an independent pathologist, with metastasis or locally advanced stage not amenable to radiotherapy or curative-intent surgery after multidisciplinary decision making;
•Subject with Prior systemic treatment with paclitaxel or doxorubicin;
•Subject with angiosarcoma with an indication and prescription of treatment by oral cyclophosphamide after multidisciplinary decision making;
•Subject with no more than two prior lines of chemotherapy (whatever the indication);
•Subjects with absence of brain or meningeal metastasis;
•Subject with at least one lesion measurable according to the RECIST, version 1.1;
•Subject with neutrophil count =1,000/mm3, platelet count = 100 000/mm3, hemoglobin level = 8 g/Dl, liver transaminases = 1.5 x ULN, total bilirubin = 1.5 x ULN, serum creatinine = 1.5 x ULN, and amylase and lipase = 1.5 x ULN.

Are the trial subjects under 18? yes
Number of subjects for this age range: 2
F.1.2 Adults (18-64 years) no
F.1.2.1 Number of subjects for this age range 16
F.1.3 Elderly (>=65 years) no
F.1.3.1 Number of subjects for this age range 6

Exclusion Criteria

•Minors or pregnant or breast-feeding women.
•Subject with a contraindication to propranolol (ie cardiogenic shock; sinus bradycardia and greater than first-degree block; Chronic Obstructive Pulmonary Disease and bronchial asthma; patients with known hypersensitivity to Propranolol; assessed by cardiovascular and pulmonar history and examinations including blood pressure, ECG; untreated Pheochromocytoma, Congestive heart failure not controlled by treatment, Prinzmetal’s angina)
•Subject with Severe Raynaud Phenomena or Raynaud Disease
•Subject with Prior systemic treatment with Cyclophosphamide as 1st or 2nd line

Study & Design

• Study Type: Interventional clinical trial of medicinal product
• Study Design: Not specified