A Study of Avastin (Bevacizumab) in Combination With Standard Chemotherapy in Children and Adolescents With Sarcoma.

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.

Status

Active, not recruiting

Phases

Phase 2

Study type

Interventional

Source

EU CTR

Registry ID

EUCTR2007-005017-19-NL

Enrollment

150

Registered

2008-05-29

Start date

2008-08-21

Completion date

Unknown

Last updated

2020-11-09

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

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

Interventions

Trade Name: Avastin® Pharmaceutical Form: Concentrate for solution for infusion INN or Proposed INN: Bevacizumab CAS Number: 216974-75-3 Current Sponsor code: RO4876646 Other descriptive name: rhuMAb,

Eligibility

Sex/Gender

All

Inclusion 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 F.1.3.1 Number of subjects for this age range

Exclusion criteria

Exclusion criteria: - previous malignant tumors - tumor invading major blood vessels - prior systemic anti-tumor treatment

Design outcomes

Primary

Measure	Time frame
Main Objective: To evaluate the efficacy of the addition of bevacizumab to chemotherapy as compared to chemotherapy alone in childhood and adolescent patients presenting with metastatic RMS and NRSTS as assessed by Event-Free Survival (EFS). ;Secondary Objective: 1. To determine the safety, tolerability and efficacy of the addition of bevacizumab to chemotherapy as compared to chemotherapy alone in patients presenting with metastatic RMS and NRSTS, as assessed by: • Adverse event profile. • Discontinuation or modification or delay of any treatment element • Overall response rate (according to RECIST v1.0) prior to local therapy. • Overall survival (OS). • Duration of response (DR) 2. To characterize the pharmacokinetic (PK) profile of bevacizumab across all age subsets of the study population. ;Primary end point(s): Event-free survival;Timepoint(s) of evaluation of this end point: 19 months after last patient randomized	—

Measure

Time frame

Main Objective: To evaluate the efficacy of the addition of bevacizumab to chemotherapy as compared to chemotherapy alone in childhood and adolescent patients presenting with metastatic RMS and NRSTS as assessed by Event-Free Survival (EFS). ;Secondary Objective: 1. To determine the safety, tolerability and efficacy of the addition of bevacizumab to chemotherapy as compared to chemotherapy alone in patients presenting with metastatic RMS and NRSTS, as assessed by: • Adverse event profile. • Discontinuation or modification or delay of any treatment element • Overall response rate (according to RECIST v1.0) prior to local therapy. • Overall survival (OS). • Duration of response (DR) 2. To characterize the pharmacokinetic (PK) profile of bevacizumab across all age subsets of the study population. ;Primary end point(s): Event-free survival;Timepoint(s) of evaluation of this end point: 19 months after last patient randomized

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Secondary

Measure	Time frame
Secondary end point(s): - AEs, lab parameters - Overall response rate, duration of response, overall survival of response - Pharmacokinetic profile;Timepoint(s) of evaluation of this end point: For AEs, throughout study every 3-4 weeks For ORR, duration of response and OS 19 months after last patient randomized For PK profile, sampling on experimental arm on first 4 cycles of induction therapy only	—

Measure

Time frame

Secondary end point(s): - AEs, lab parameters - Overall response rate, duration of response, overall survival of response - Pharmacokinetic profile;Timepoint(s) of evaluation of this end point: For AEs, throughout study every 3-4 weeks For ORR, duration of response and OS 19 months after last patient randomized For PK profile, sampling on experimental arm on first 4 cycles of induction therapy only

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Countries

Belgium, Canada, Chile, Czech Republic, France, Germany, Israel, Italy, Netherlands, Poland, Russian Federation, Spain, United Kingdom

Contacts

Public ContactTrial Information Support Line-TISL

F. Hoffmann-La Roche Ltd

global.rochegenentechtrials@roche.com

Outcome results

None listed

Source: EU CTR (via WHO ICTRP) · Data processed: Feb 4, 2026