A study of Avastin (Bevacizumab) in Combination with Standard Chemotherapy in Children and Adolescents with Sarcoma

Phase 1

• Conditions: Patients aged 6 months to <18 years, presenting with metastatic rhabdomyosarcoma and non-rhabdomyosarcoma soft tissue sarcoma.; MedDRA version: 14.0 Level: PT Classification code 10039022 Term: Rhabdomyosarcoma System Organ Class: 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps); MedDRA version: 14.0 Level: LLT Classification code 10065867 Term: Alveolar rhabdomyosarcoma System Organ Class: 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps); MedDRA version: 14.0 Level: PT Classification code 10001882 Term: Alveolar soft part sarcoma System Organ Class: 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps); MedDRA version: 14.0 Level: LLT Classification code 10039494 Term: Sarcoma NOS System Organ Class: 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps); MedDRA version: 14.0 Level: LLT Classification code 10060651 Term: Malignant hemangiopericytoma metastatic System Organ Class: 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps); MedDRA version: 14.0 Level: LLT Classification code 10065868 Term: Embryonal rhabdomyosarcoma System Organ Class: 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps); MedDRA version: 14.0 Level: LLT Class; Therapeutic area: Diseases [C] - Cancer [C04]

• Registration Number: EUCTR2007-005017-19-DE
• Lead Sponsor: F. Hoffmann-La Roche Ltd

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2010-05-25
• Last Update Posted: 10 December 2019

Recruitment & Eligibility

• Status: ot Recruiting
• Sex: Not specified
• Target Recruitment: 154

Inclusion Criteria

- childhood and adolescent patients aged >/=6 months to 18 years of age
- metastatic rhabdomyosarcoma or non-rhabdomyosarcoma soft tissue sarcoma
- adequate bone marrow function
- adequate renal and liver function
- adequate blood clotting
Are the trial subjects under 18? yes
Number of subjects for this age range:
F.1.2 Adults (18-64 years) no
F.1.2.1 Number of subjects for this age range
F.1.3 Elderly (>=65 years) no
F.1.3.1 Number of subjects for this age range

Exclusion Criteria

- previous malignant tumours.
- tumor invading major blood vessels
- prior systemic anti-tumor treatment

Study & Design

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