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: 20.0Level: PTClassification code 10061526Term: Malignant mesenchymomaSystem Organ Class: 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps); MedDRA version: 20.0Level: PTClassification code 10065868Term: Embryonal rhabdomyosarcomaSystem Organ Class: 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps); MedDRA version: 20.0Level: PTClassification code 10065867Term: Alveolar rhabdomyosarcomaSystem Organ Class: 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps); MedDRA version: 20.0Level: LLTClassification code 10058387Term: Schwannoma malignantSystem Organ Class: 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps); MedDRA version: 20.0Level: LLTClassification code 10039024Term: Rhabdomyosarcoma NOSSystem Organ Class: 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps); MedDRA version: 20.0Level: LLTClassification code 10039494Term: Sarcoma NOSSystem Organ Class: 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps); MedDRA version: 20.0Level: PTClassification code 10039022Term: RhabdomyosarcomaSystem Organ Class: 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps); MedDRA version: 20.0Level: PTClassification code 10042864Term: Synovial sarcoma metastaticSystem Organ Class: 10029104 - Neoplasms; MedDRA version: 20.0Level: LLTClassification code 10039026Term: Rhabdomyosarcoma previously untreatedSystem Organ Class: 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps)

• Registration Number: EUCTR2007-005017-19-NL
• 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: 2008-05-29
• Last Update Posted: 9 November 2020

Recruitment & Eligibility

• Status: ot Recruiting
• Sex: All
• 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: 150
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 tumors
- tumor invading major blood vessels
- prior systemic anti-tumor treatment

Study & Design

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