Phase 4
Completed N=95
An Extension Study to Provide Continued Bevacizumab Therapy to Participants With Solid Tumors Who Were Previously Enrolled in a Roche/Genentech Sponsored Study
Neoplasms
Source: ClinicalTrials.gov NCT01588184 ↗
Enrolled (actual)
95
Serious AEs
17.9%
Results posted
Nov 2020
Primary outcomePrimary: Percentage of Participants With Adverse Events — 90.9; 78.0; 71.4; 100.0 percentage of participants
◆ Published Evidence
Emerging
19citations · ~4 / year
A Long-Term Extension Study of Bevacizumab in Patients With Solid Tumors.
Summary
This single-arm, open-label, multicenter extension study will provide continued bevacizumab therapy to participants with solid tumors who were previously enrolled in a Roche/Genentech sponsored study and who derived benefit from the bevacizumab therapy. Participants will receive the same dose and regimen of bevacizumab as used in the previous parent trial and continue this treatment until progression of disease or unacceptable toxicity, withdrawal of consent or death whichever occurs first.
Linked Publications
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A Long-Term Extension Study of Bevacizumab in Patients With Solid Tumors.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Percentage of Participants With Adverse Events |
90.9; 78.0; 71.4; 100.0; 75.0; 83.2 | — |
| SECONDARY Progression Free Survival (PFS) |
35.31; 24.39; 17.98; 9.31; 17.14; 11.31 | — |
| SECONDARY Overall Survival (OS) |
38.82; 27.35; 20.30; 11.98; 18.31; 12.99 | — |
Eligibility Criteria
Inclusion Criteria
- Participant is treated with bevacizumab at the end of the Roche/Genentech sponsored parent trial and continues to have benefit as judged by the investigator
- Eligible for continuation of bevacizumab treatment at the end of a parent trial, according to parent trial protocol
- Able to comply with this extension study protocol (MO25757)
Exclusion Criteria
- Evidence of disease progression assessed according to parent trial protocol during the screening phase for this extension study
- Evidence of any adverse event potentially attributable to bevacizumab, for which the local label recommends permanent discontinuation
- A treatment interruption with bevacizumab of more than 42 days since the last administration of bevacizumab in the parent trial
- Evidence of any other disease that would put the participant at high risk for treatment-related complications
Data sourced from ClinicalTrials.gov (NCT01588184) and the linked publication. 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. Informational only — not medical advice.