Safety of Effivia®, a Bevacizumab Biosimilar | NCT06313268

Studies
Safety of Effivia®, a Bevacizumab Biosimilar

NCT06313268

Sponsor

Laboratorios Liomont

Status

Completed

Last Update Posted

Oct 10, 2024Actual

Enrollment

83Actual

Phase

Not provided

Conditions

Metastatic Colorectal Cancer
Metastatic Cervical Cancer
Non Squamous Non Small Cell Lung Cancer

Interventions

Bevacizumab Biosimilar MB02

Countries

Mexico

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Oct 2024

Overall Recruitment Status or Expanded Access Status

Completed

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Aug 11, 2022Actual

Primary Completion Date

Apr 17, 2024Actual

Completion Date

Sep 2, 2024Actual

First Submitted Date

Feb 21, 2024

First Submission Date that Met QC Criteria

Mar 8, 2024

First Posted Date

Mar 15, 2024Actual

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Oct 8, 2024

Last Update Posted Date

Oct 10, 2024Actual

Name	Class
Servicios Especializados en Ensayos Clínicos, S.C.	UNKNOWN

Oversight Module

Has Data Monitoring Committee (DMC)

Is FDA Regulated Drug

Yes

Is FDA Regulated Device

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

FDAAA801 Violation

Not provided

Description Module

Brief 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.

Detailed Description

Not provided

Design Module

Study Type

Observational

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Yes

Target Follow-Up Duration

2 Years

Phases

Not provided

Interventional Study Design

Allocation

Not provided

Intervention Model

Biospecimen

No data available

No data is available for this block.

Enrollment

83Actual

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
Test group		Bevacizumab (Effivia®)	Drug: Bevacizumab Biosimilar MB02

Interventions

Name	Type	Description	Arm Group Labels	Other Names
Bevacizumab Biosimilar MB02	Drug	5 mg/kg to 15 mg/kg in combination with chemotherapy.	Test group

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Adverse events	Frequency and characteristics of adverse events (serious and non serious)	From date of patient inclusion to the end of Cycle 1 (each cycle is up to six months)

Secondary Outcomes

Not provided

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

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.

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

Not provided

Standard Ages

AdultOlder 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.

Sampling Method

Non-Probability Sample

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Not provided

Locations

Facility	Status	City	State	ZIP	Country	Contacts
UMAE Hospital de Especialidades No. 1		León	Guanajuato	37320	Mexico
Hospital de Gineco-Obstetricia No. 3

IPD Sharing Statement Module

Plan to Share IPD

Description

Not provided

Types

Not provided

Time Frame

Not provided

Access Criteria

Not provided

URL

Not provided

Condition Browse Module

MeSH Terms

ID	Term
D015179	Colorectal Neoplasms
D002583	Uterine Cervical Neoplasms

Ancestor Terms

ID	Term
D007414	Intestinal Neoplasms
D005770	Gastrointestinal Neoplasms
D004067	Digestive System Neoplasms
D009371	Neoplasms by Site

Browse Leaves

Not provided

Browse Branches

Not provided