Clinical trial · Observational
Safety of Effivia®, a Bevacizumab Biosimilar
Post-marketing Safety of Effivia®, a Bevacizumab Biosimilar: Phase IV, Observational, Multicenter Clinical Study in Mexican Population
NCT06313268CI-TRIAL-00081483completedClinicalTrials.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 is a post-marketing observational study aimed to evaluated the safety profile of Effivia®, a biosimilar of bevacizumab, in mexican patients with different types of cancer.
Conditions
Conditions (3)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Metastatic Cervical Cancer | Malignant Cervical Neoplasm | CURATED_BROADER | 0.78 |
| Metastatic Colorectal Cancer | Malignant Colorectal Neoplasm | CURATED_BROADER | 0.80 |
| Non Squamous Non Small Cell Lung Cancer | Lung Non-Squamous Non-Small Cell Carcinoma | ALIAS | 0.90 |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Bevacizumab Biosimilar MB02 | Drug | Bevacizumab | ALIAS |
Design
Arms and outcomes
Arms (1)
- label
- Test group
- description
- Bevacizumab (Effivia®)
- interventionNames
- Drug: Bevacizumab Biosimilar MB02
Primary outcomes (1)
- measure
- Adverse events
- timeFrame
- From date of patient inclusion to the end of Cycle 1 (each cycle is up to six months)
- description
- Frequency and characteristics of adverse events (serious and non serious)
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
Inclusion Criteria: * Male and female patients, 18 years and older. * Patients with metastatic colorectal cancer,unresectable, locally advanced, recurrent or metastatic non-squamous non-small cell lung cancer, metastatic renal cell carcinoma, persistent, recurrent, or metastatic cervical cancer, or epithelial ovarian, fallopian tube, or primary peritoneal cancer naive to bevacizumab therapy (Effivia®). * Provide written informed consent. Exclusion Criteria: * History of recent surgery or wound healing complications. * History of gastrointestinal perforations or fistula. * History of renal injury and proteinuria. * Recent surgical intervention. * Pregnant or nursing women. * History of bevacizumab, monoclonal antibodies, or CHO cells-derived products hypersensitivity. * Other safety concerns or bevacizumab contraindications.
References
Publications (0)
Data not yet available
No reference posted for this study.