Clinical trial · Interventional
A Study of Bevacizumab (Avastin) in Combination With Chemotherapy in Participants With Metastatic Cancer of the Colon or Rectum.
First-Line Bevacizumab and Chemotherapy in Metastatic Cancer of the Colon or Rectum First BEAT (Bevacizumab Expanded Access Trial)- Brazilian Extension
NCT01169558CI-TRIAL-00025091completedPhase 3Results postedClinicalTrials.gov clinicaltrialsProvenance
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
This expanded access study will assess the safety and efficacy of intravenous bevacizumab (5 mg/kg every 2 weeks or 7.5 mg/kg every 3 weeks) in combination with fluoropyrimidine-based chemotherapy as first line treatment in participants with metastatic cancer of the colon or rectum. The anticipated time on study treatment is 3-12 months.
Conditions
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Colorectal Cancer | Malignant Colorectal Neoplasm | CURATED_BROADER | 0.80 |
Interventions
Interventions (2)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Bevacizumab | Drug | Bevacizumab | ALIAS |
| Fluoropyrimidine-based Chemotherapy | Drug | — | UNRESOLVED |
Design
Arms and outcomes
Arms (1)
- type
- EXPERIMENTAL
- label
- Bevacizumab
- description
- Bevacizumab will be administered in combination with fluoropyrimidine-based chemotherapy as first line treatment in participants with metastatic cancer of the colon or rectum until disease progression or study completion.
- interventionNames
- Drug: Bevacizumab
- Drug: Fluoropyrimidine-based Chemotherapy
Primary outcomes (1)
- measure
- Safety: Number of Participants With Serious and Specific Adverse Events
- timeFrame
- Up to approximately 3 years
- description
- A serious adverse event was defined as any experience that suggested a significant hazard, contraindication, side effect, or precaution, and fulfilled any of the following criteria: fatal (resulted in death), life-threatening, required in-patient hospitalization or prolongation of existing hospitalization, resulted in persistent or significant disability/incapacity, was a congenital anomaly/birth defect, was medically significant or required intervention to prevent any of the other outcomes listed here. Specific adverse events (Spec AEs) included the following: hypertension, bleeding/hemorrhage, proteinuria, wound healing complications, thrombosis/thrombus/embolism (t/t/e), thrombosis/thrombus/embolism - vascular access, gastrointestinal perforation, and infusion (injection) site reaction.
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
Inclusion Criteria: * Previously untreated metastatic colon or rectal cancer; * Scheduled to begin fluoropyrimidine-based chemotherapy as a first line treatment. Exclusion Criteria: * Prior chemotherapy for metastatic colon or rectal cancer; * Planned radiotherapy for underlying disease; * central nervous system metastases; * Major surgical procedure, open biopsy, or significant traumatic injury within 28 days before study start.
References
Publications (0)
Data not yet available
No reference posted for this study.