EUCTR2007-005017-19-Outside-EU/EEA
Active, not recruiting
Not Applicable
Open-label, multi-center, randomized, phase II study evaluating the addition of bevacizumab to chemotherapy in childhood and adolescent patients presenting with metastatic rhabdomyosarcoma and non-rhabdomyosarcoma soft tissue sarcoma.
ConditionsPatients aged 6 months to <18 years, presenting with metastatic rhabdomyosarcoma and non-rhabdomyosarcoma soft tissue sarcoma.MedDRA version: 14.1Level: LLTClassification code 10065868Term: Embryonal rhabdomyosarcomaSystem Organ Class: 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps)MedDRA version: 14.1Level: PTClassification code 10061526Term: Malignant mesenchymomaSystem Organ Class: 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps)MedDRA version: 14.1Level: LLTClassification code 10065867Term: Alveolar rhabdomyosarcomaSystem Organ Class: 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps)MedDRA version: 14.1Level: LLTClassification code 10058387Term: Schwannoma malignantSystem Organ Class: 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps)MedDRA version: 14.1Level: LLTClassification code 10039494Term: Sarcoma NOSSystem Organ Class: 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps)MedDRA version: 14.1Level: LLTClassification code 10039024Term: Rhabdomyosarcoma NOSSystem Organ Class: 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps)MedDRA version: 14.1Level: PTClassification code 10039022Term: RhabdomyosarcomaSystem Organ Class: 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps)MedDRA version: 14.1Level: LLTClassification code 10039026Term: Rhabdomyosarcoma previously untreatedSystem Organ Class: 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps)MedDRA version: 14.1Level: PTClassification code 10024189Term: LeiomyosarcomaSystem Organ Class: 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps)MedDRA version: 14.1Level: PTClassification code 10042864Term: Synovial sarcoma metastaticSystem Organ Class: 10029104 - NeoplasmTherapeutic area: Diseases [C] - Cancer [C04]
DrugsAvastin®
Overview
- Phase
- Not Applicable
- Intervention
- Not specified
- Conditions
- Patients aged 6 months to <18 years, presenting with metastatic rhabdomyosarcoma and non-rhabdomyosarcoma soft tissue sarcoma.
- Sponsor
- F. Hoffmann-La Roche Ltd
- Enrollment
- 150
- Status
- Active, not recruiting
- Last Updated
- 13 years ago
Overview
Brief Summary
No summary available.
Investigators
Eligibility Criteria
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
Exclusion Criteria
- •\- previous malignant tumors
- •\- tumor invading major blood vessels
- •\- prior systemic anti\-tumor treatment
Outcomes
Primary Outcomes
Not specified
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