Metastatic Colorectal CancerNCT06313268
Safety of Effivia®, a Bevacizumab Biosimilar
An observational study of Metastatic Colorectal Cancer and Metastatic Cervical Cancer, run by Laboratorios Liomont at 5 sites in Mexico.
Trial summary
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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Metastatic Colorectal Cancer, Metastatic Cervical Cancer, Non Squamous Non Small Cell Lung Cancer
- What is being tested?
- Bevacizumab Biosimilar MB02
- How many people
- 83 participants
- Where
- 5 sitesMexico
- Study dates
- 11 Aug 2022to 2 Sep 2024
- How long will I take part?
- 2 Years
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Naive to bevacizumab, adult patients with metastatic colorectal cancer, metastatic cervical cancer, non-squamous non-small cell lung cancer, and other cancer types where Bevacizumab therapy is indicated.
Who may be able to join
- 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.
Who cannot join
- 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.
Trial locations and contacts
5 sites in 1 country.
5 sites in 1 country
Mexico5 sites
Hospital de Gineco-Obstetricia No. 3
Azcapotzalco, Mexico City, 02990
Hospital de Oncología, UMAE Centro Médico Nacional Siglo XXI
Cuauhtémoc, Mexico City, 06720
UMAE Hospital de Especialidades No. 1
León, Guanajuato, 37320
Hospital de Oncología IMSS Puebla
Puebla City, 07200
Instituto Nacional de Cancerología
Tlalpan, Mexico City, 14080
About this study
Official title: Post-marketing Safety of Effivia®, a Bevacizumab Biosimilar: Phase IV, Observational, Multicenter Clinical Study in Mexican Population
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
- Metastatic Colorectal Cancer, Metastatic Cervical Cancer, Non Squamous Non Small Cell Lung Cancer
- Being tested
- Bevacizumab Biosimilar MB02
- Medical subject headings
- Colorectal Neoplasms, Uterine Cervical Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Bevacizumab Biosimilar MB02Drug
Also called Effivia®
5 mg/kg to 15 mg/kg in combination with chemotherapy.
| Study group | Role | What they receive |
|---|---|---|
| Test group | Bevacizumab (Effivia®) Receives: Drug: Bevacizumab Biosimilar MB02 |
What is being measured
The primary outcome is the main question the study is designed to answer.
Adverse events
Frequency and characteristics of adverse events (serious and non serious)
Measured: From date of patient inclusion to the end of Cycle 1 (each cycle is up to six months)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Mar 2024
- Study start11 Aug 2022
- Primary completion17 Apr 2024
- Study completion2 Sep 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Metastatic Colorectal CancerStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Case only
- Time perspective
- Prospective
- Enrolment
- 83 participants (actual)
- Target duration
- 2 Years
Sponsor and investigators
- Lead sponsor
- Laboratorios Liomont
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- Servicios Especializados en Ensayos Clínicos, S.C.
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06313268
- Sponsor's protocol ID
- LT-02-20
- Status last verified
- Oct 2024
- First submitted
- 21 Feb 2024
- Last updated
- 10 Oct 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 10 Oct 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Post-marketing Safety of Effivia®, a Bevacizumab Biosimilar: Phase IV, Observational, Multicenter Clinical Study in Mexican Population
- ClinicalTrials.gov ID
- NCT06313268
- Acronym / sponsor ID
- LT-02-20
- Conditions
- Metastatic Colorectal Cancer, Metastatic Cervical Cancer, Non Squamous Non Small Cell Lung Cancer
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 83 participants (actual)
- Lead sponsor
- Laboratorios LiomontIndustry (pharma, biotech, devices)
- Collaborators
- Servicios Especializados en Ensayos Clínicos, S.C.
- Study start
- 11 Aug 2022 (actual)
- Primary completion
- 17 Apr 2024 (actual)
- Study completion
- 2 Sep 2024 (actual)
- First posted
- 15 Mar 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Case only
- Time perspective
- Prospective
- Target follow-up
- 2 Years
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Test group | – | Drug: Bevacizumab Biosimilar MB02Bevacizumab (Effivia®) |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Naive to bevacizumab, adult patients with metastatic colorectal cancer, metastatic cervical cancer, non-squamous non-small cell lung cancer, and other cancer types where Bevacizumab therapy is indicated.
Key inclusion criteria (3 listed)
- 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.
Key exclusion criteria (7 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Bevacizumab Biosimilar MB02Also: Effivia®5 mg/kg to 15 mg/kg in combination with chemotherapy. | Drug | Test group |
Primary outcome
Adverse events
Time frame: From date of patient inclusion to the end of Cycle 1 (each cycle is up to six months)
Frequency and characteristics of adverse events (serious and non serious)
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 10 Oct 2024.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
5 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Metastatic Colorectal Cancer and Metastatic Cervical Cancer, run by Laboratorios Liomont at 5 sites in Mexico.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 10 Oct 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 5 sites in Mexico. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Adverse events (time frame: From date of patient inclusion to the end of Cycle 1 (each cycle is up to six months)). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 10 Oct 2024.