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Clinical Trials/EUCTR2007-005017-19-DE
EUCTR2007-005017-19-DE
Active, not recruiting
Phase 1

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.

F. Hoffmann-La Roche Ltd0 sites154 target enrollmentMay 25, 2010
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ConditionsPatients 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 ClassTherapeutic area: Diseases [C] - Cancer [C04]
DrugsAvastin®

Overview

Phase
Phase 1
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
154
Status
Active, not recruiting
Last Updated
6 years ago
OverviewInvestigatorsEligibility CriteriaOutcomesSimilar Trials

Overview

Brief Summary

No summary available.

Registry
who.int
Start Date
May 25, 2010
End Date
TBD
Last Updated
6 years ago
Study Type
Interventional clinical trial of medicinal product

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:
  • •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 tumours.
  • •\- tumor invading major blood vessels
  • •\- prior systemic anti\-tumor treatment

Outcomes

Primary Outcomes

Not specified

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A Study of Avastin (Bevacizumab) in Combination With Standard Chemotherapy in Children and Adolescents With Sarcoma.
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A Study of Avastin (Bevacizumab) in Combination With Standard Chemotherapy in Children and Adolescents With Sarcoma.Patients aged 6 months to <18 years, presenting with metastatic rhabdomyosarcoma and non-rhabdomyosarcoma soft tissue sarcoma.MedDRA version: 20.0 Level: PT Classification code 10061526 Term: Malignant mesenchymoma System Organ Class: 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps)MedDRA version: 20.0 Level: PT Classification code 10065868 Term: Embryonal rhabdomyosarcoma System Organ Class: 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps)MedDRA version: 20.0 Level: PT Classification code 10065867 Term: Alveolar rhabdomyosarcoma System Organ Class: 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps)MedDRA version: 20.0 Level: LLT Classification code 10058387 Term: Schwannoma malignant System Organ Class: 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps)MedDRA version: 20.0 Level: LLT Classification code 10039024 Term: Rhabdomyosarcoma NOS System Organ Class: 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps)MedDRA version: 20.0 Level: LLT Classification code 10039494 Term: Sarcoma NOS System Organ Class: 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps)MedDRA version: 20.0 Level: PT Classification code 10039022 Term: RhabdomyosarcomaTherapeutic area: Diseases [C] - Cancer [C04]
EUCTR2007-005017-19-BEF. Hoffmann-La Roche Ltd154
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A Study of Avastin (Bevacizumab) in Combination With Standard Chemotherapy in Children and Adolescents With Sarcoma.Patients aged 6 months to <18 years, presenting with metastatic rhabdomyosarcoma and non-rhabdomyosarcoma soft tissue sarcoma.MedDRA version: 18.1 Level: PT Classification code 10061526 Term: Malignant mesenchymoma System Organ Class: 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps)MedDRA version: 18.1 Level: PT Classification code 10065868 Term: Embryonal rhabdomyosarcoma System Organ Class: 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps)MedDRA version: 18.1 Level: PT Classification code 10065867 Term: Alveolar rhabdomyosarcoma System Organ Class: 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps)MedDRA version: 18.1 Level: LLT Classification code 10058387 Term: Schwannoma malignant System Organ Class: 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps)MedDRA version: 18.1 Level: LLT Classification code 10039024 Term: Rhabdomyosarcoma NOS System Organ Class: 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps)MedDRA version: 18.1 Level: LLT Classification code 10039494 Term: Sarcoma NOS System Organ Class: 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps)MedDRA version: 18.1 Level: PT Classification code 10039022 Term: RhabdomyosarcomaTherapeutic area: Diseases [C] - Cancer [C04]
EUCTR2007-005017-19-CZF. Hoffmann-La Roche Ltd154
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A Study of Avastin (Bevacizumab) in Combination With Standard Chemotherapy in Children and Adolescents With SarcomaPatients aged 6 months to <18 years, presenting with metastaticrhabdomyosarcoma and non-rhabdomyosarcoma soft tissuesarcoma.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: LLTClassification code 10039026Term: Rhabdomyosarcoma previously untreatedSystem Organ Class: 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps)MedDRA version: 20.0Level: PTClassification code 10024189Term: LeiomyosarcomaSystem 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 - Neoplasm
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