Phase 3
N=649
A Study of Avastin (Bevacizumab) Added to Interferon Alfa-2a (Roferon) Therapy in Patients With Metastatic Renal Cell Cancer With Nephrectomy
Renal Cell Cancer
Bottom Line
View on ClinicalTrials.gov: NCT00738530 ↗Enrolled (actual)
649
Serious AEs
24.0%
Results posted
Jun 2016
Primary outcome: Primary: Percentage of Participants Who Died — 67.3; 69.6 percentage of participants
Study Design & Population
- Study type
- Interventional
- Phase
- Phase 3
- Interventions
- Bevacizumab [Avastin] (Drug); Interferon alfa 2a [Roferon] (Drug); Placebo (Drug)
- Age
- Adult, Older Adult · 18+ yrs
- Sex
- All
- Sponsor
- Hoffmann-La Roche
- Primary completion
- Sep 2008
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Percentage of Participants Who Died |
67.3; 69.6 | — |
| PRIMARY Overall Survival (OS) Duration |
23.3; 21.3 | 0.3360 |
| SECONDARY Percentage of Participants With Disease Progression or Death |
92.0; 92.5 | — |
| SECONDARY Progression Free Survival (PFS) According to Modified Response Evaluation Criteria in Solid Tumors (mRECIST) |
10.2; 5.5 | 0.0004 sig |
| SECONDARY Time to Progression (TTP) According to Modified Response Evaluation Criteria in Solid Tumors (mRECIST) |
10.2; 5.5 | 0.0002 sig |
| SECONDARY Percentage of Participants With Treatment Failure |
90.5; 91.6 | — |
| SECONDARY Time to Treatment Failure (TTF) According to Modified Response Evaluation Criteria in Solid Tumors (mRECIST) |
8.1; 4.5 | 0.0023 sig |
| SECONDARY Percentage of Participants With Objective Response According to mRECIST |
32.4; 12.5 | <.0001 sig |
| SECONDARY Percentage of Participants With Best Overall Response According to Modified Response Evaluation Criteria in Solid Tumors (mRECIST) |
1.6; 2.4; 30.7; 10.0; 44.4; 50.5 | — |
| SECONDARY Change From Baseline in Karnofsky Performance Status |
90; 90; 0; 0; 0; 0 | — |
Summary
This 2-arm study will evaluate the efficacy and safety of Avastin versus placebo in combination with Roferon as first-line treatment in participants with metastatic renal cell cancer (clear cell type) who have had nephrectomy. The anticipated time of study treatment is 1-2 years, and the target sample size is greater than (>)500 individuals.
Eligibility Criteria
Inclusion Criteria
- metastatic renal cell cancer (clear cell type);
- nephrectomy;
- absence of proteinuria.
Exclusion Criteria
- prior systemic treatment for metastatic renal cell cancer;
- major surgical procedure, open biopsy or significant traumatic injury within 28 days prior to study treatment start;
- presence of brain metastases or spinal cord compression;
- ongoing need for full dose anticoagulants;
- uncontrolled hypertension;
- clinically significant cardiovascular disease.
Data sourced from ClinicalTrials.gov (NCT00738530). 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.