Phase 2
N=154
A Study of Avastin (Bevacizumab) in Combination With Standard Chemotherapy in Children and Adolescents With Sarcoma.
Sarcoma
Bottom Line
View on ClinicalTrials.gov: NCT00643565 ↗Enrolled (actual)
154
Serious AEs
89.3%
Results posted
Feb 2016
Primary outcome: Primary: Percentage of Participants Who Experienced Event-Free Survival (EFS) Events as Per Independent Review Committee (IRC) Assessment — 52.5; 68.9 percentage of participants
Study Design & Population
- Study type
- Interventional
- Phase
- Phase 2
- Interventions
- Standard chemotherapy (Drug); bevacizumab [Avastin] (Drug)
- Age
- Pediatric, Adult · 0+ yrs
- Sex
- All
- Sponsor
- Hoffmann-La Roche
- Primary completion
- May 2015
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Percentage of Participants Who Experienced Event-Free Survival (EFS) Events as Per Independent Review Committee (IRC) Assessment |
52.5; 68.9 | — |
| PRIMARY EFS Duration as Per IRC Assessment |
14.85; 20.63 | 0.7189 |
| SECONDARY Percentage of Participants With Objective Response Prior to First Local Therapy Assessed by RECIST v1.0 Criteria |
36.0; 54.0 | — |
| SECONDARY Percentage of Participants Who Experienced EFS Events Among Participants Who Had Objective Response |
40.7; 76.5 | — |
| SECONDARY Duration of Response |
NA; 17.48 | — |
| SECONDARY Percentage of Participants Who Died |
50; 51.4 | — |
| SECONDARY Overall Survival Duration |
24.02; 32.79 | 0.3211 |
| SECONDARY Area Under the Curve at Steady State (AUCss) of Bevacizumab |
1010 | — |
| SECONDARY Volume of Distribution of Bevacizumab |
2070 | — |
| SECONDARY Half-Life of Bevacizumab |
20.8 | — |
| SECONDARY Clearance of Bevacizumab |
167 | — |
Summary
This open-label two-arm study will assess the safety and efficacy of a combination of bevacizumab + standard chemotherapy with standard chemotherapy alone as active comparator in childhood and adolescent patients with metastatic rhabdomyosarcoma or non-rhabdomyosarcoma soft tissue sarcoma. Patients will be randomized to receive bevacizumab + standard chemotherapy or standard chemotherapy alone. Treatment will consist of 9 x 3-week cycles of induction treatment (standard chemotherapy with or without bevacizumab 7.5 mg/kg iv on day 1 of each cycle) followed by 12 x 4-week cycles of maintenance treatment (standard chemotherapy with or without bevacizumab 5 mg/kg iv on days 1 and 15 of each cycle). The anticipated time on study treatment is 1-2 years.
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
Exclusion Criteria
- previous malignant tumors
- tumor invading major blood vessels
- prior systemic anti-tumor treatment
Data sourced from ClinicalTrials.gov (NCT00643565). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.