NCT06313268Completed
Safety of Effivia®, a Bevacizumab Biosimilar
Post-marketing Safety of Effivia®, a Bevacizumab Biosimilar: Phase IV, Observational, Multicenter Clinical Study in Mexican Population
Source: ClinicalTrials.gov · Last updated 10 Oct 2024
Brief summary (registry, in English)
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.
- Status (registry)
- Completed
- Study type
- Observational
- Enrollment
- 83 (actual)
- First submitted
- 21 Feb 2024
- Start date
- 11 Aug 2022
- Primary completion date
- 17 Apr 2024
- Lead sponsor
- Laboratorios Liomont
- Diseases
- Cervical cancer, Lung cancer, Colorectal cancer
- NCT number
- NCT06313268
What you commit to
- Study type: Observational
- Participants enrolled: 83
- From 11 Aug 2022 to the primary completion date, 17 Apr 2024
- 5 sites in 1 country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Prior treatment
- Recent surgical intervention.
- Other safety concerns or bevacizumab contraindications.
Other illness
- History of recent surgery or wound healing complications.
- History of gastrointestinal perforations or fistula.
- History of renal injury and proteinuria.
- History of bevacizumab, monoclonal antibodies, or CHO cells-derived products hypersensitivity.
Other
- Pregnant or nursing women.
Who the study is looking for
- 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.
Age in the registry: 18 years to - · Sex: All · Does not accept healthy volunteers
Sites (5)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| Hospital de Gineco-Obstetricia No. 3 Coordinator of this site? Confirm its status | Azcapotzalco | Mexico | Unknown status |
| Hospital de Oncología, UMAE Centro Médico Nacional Siglo XXI Coordinator of this site? Confirm its status | Cuauhtémoc | Mexico | Unknown status |
| UMAE Hospital de Especialidades No. 1 Coordinator of this site? Confirm its status | León | Mexico | Unknown status |
| Hospital de Oncología IMSS Puebla Coordinator of this site? Confirm its status | Puebla City | Mexico | Unknown status |
| Instituto Nacional de Cancerología Coordinator of this site? Confirm its status | Tlalpan | Mexico | Unknown status |
This page is information, not medical advice. Discuss any trial with your doctor.