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Bioequivalence Study Bevacizumab Biosimilar (BEVZ92) Versus Bevacizumab (AVASTIN®) in First-line Treatment mCRC Patients | Clinical Trials | Clareo Health

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Bioequivalence Study Bevacizumab Biosimilar (BEVZ92) Versus Bevacizumab (AVASTIN®) in First-line Treatment mCRC Patients

Open Label Randomized Bioequivalence Study to Evaluate the Pharmacokinetic and Safety Profile of Bevacizumab Biosimilar (BEVZ92) vs Bevacizumab (AVASTIN®), Both With FOLFOX or FOLFIRI, in First-line Treatment for mCRC Patients

NCT02069704•mAbxience Research S.L.

View on ClinicalTrials.gov

Summary

This is a multicenter, open label, randomized bioequivalence study of BEVZ92 (bevacizumab biosimilar) and Avastin® with 2 parallel arms to compare the pharmacokinetic (PK) profile of BEVZ92 and Avastin® in combination with FOLFOX (any) or FOLFIRI chemotherapy. FOLFOX (any) or FOLFIRI will be chosen as per investigator criteria based on the hospital standard of care.

Detailed Description

Planned enrolment duration: 12 months. Pre-treatment period (included in enrolment period): 1 month. Treatment period: Patients will continue treatment until disease progression or unacceptable toxicity, or withdrawal of consent.

Eligibility

Age

18 - No limit years

Sex

ALL

Healthy Volunteers

Inclusion Criteria

•1. Patient must not have had prior chemotherapy for advanced or metastatic disease. Patients could have received adjuvant chemotherapy or adjuvant chemo-radiotherapy.
•2. Patient with mCRC for whom bio-chemotherapy is indicated.
•3. Patients must have at least one measurable non-irradiated site of disease according to RECIST (version 1.1) criteria. If the patient has had previous irradiation of the marker lesion(s), there must be evidence of progression since the radiation.
•4. Minimum of 4 weeks since any major surgery, completion of radiation, or completion of all prior systemic anticancer therapy
•5. Eastern Cooperative Oncology Group (ECOG) performance status ≤ 2.
•6. Adequate bone marrow function
•7. Adequate liver function defined within specific parameters
•8. Adequate renal function defined within specific parameters
•9. Adequate coagulation parameters defined within specific parameters
•10. Negative pregnancy test for females of a childbearing potential.
+2 more criteria

Exclusion Criteria

•1. Prior treatment for advanced or metastatic colorectal cancer.
•2. Prior treatment with an anti-angiogenesis agent, in either the neoadjuvant or adjuvant setting.
•3. Concurrent use of investigational anti-neoplastic agents (including up to 4 weeks prior to enrolment).
•4. History of any other malignancy unless the malignancy is in complete remission and the patient has been off all therapy for that malignancy for at least 5 years.
•5. Chronic treatment with systemic steroids or other immunosuppressive agents; topical or inhaled corticosteroids are allowed.
•6. Scheduled immunization with attenuated live vaccines during study period or within 1 week prior to study entry.
•7. Uncontrolled brain or lepto-meningeal metastases, including patients who continue to require glucocorticoids for brain or lepto-meningeal metastases.
•8. Patients with active bleeding or history of bleeding diathesis on oral anti-vitamin K medication (except low dose coumadin) within the past 6 month prior to randomization or coagulopathy.
•9. Patients with history of cerebral vascular accident, transient ischemic attack, or subarachnoid haemorrhage within the past 6 month prior to randomization.
•10. Patients who have any severe and/or uncontrolled medical conditions or other conditions that could affect their participation in the study
+4 more criteria

Locations (18)

Hospital de Gastroenterologia "Dr. Carlos Bonorino Udaondo"

Buenos Aires, Argentina

Instituto Oncológico de Rosario

Rosario, Argentina

Fundaçáo Pio XII - Hospital do Cancer de Barretos

Barretos, Brazil

Hospital Caridade

Ijuí, Brazil

Hospital Sao Lucas da Pucrs

Porto Alegre, Brazil

Centro de Pesquisa do Instituto Brasileiro de Controle do Câncer - IBCC

São Paulo, Brazil

Hosp. A.C Camargo

São Paulo, Brazil

Instituto do Cancer del estado de S. Paulo (ICEPS )

São Paulo, Brazil

M S Patel Cancer Centre- Shree Krishna Hospital

Karamsad, Gujarat, India

Sri Ramachandra Hospital

Chennai, India

Key Dates

Start Date

October 29, 2014

Primary Completion Date

October 1, 2015

Completion Date

June 1, 2017

Last Updated

July 23, 2019

Enrollment

142

ACTUAL participants

Conditions

Metastatic Colorectal Cancer (mCRC)

Interventions

Bevacizumab biosimilar (BEVZ92)

DRUG

Avastin® (bevacizumab, reference product)

DRUG

Assessing a Regorafenib-irinotecan Combination Versus Regorafenib Alone in Metastatic Colorectal Cancer Patients

NCT03829462

Metastatic Colorectal Cancer (mCRC)

View study

Data Source & Attribution

This clinical trial information is sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.

ClinicalTrials.gov last update: July 23, 2019Data synced to Clareo: March 29, 2026

Modifications: This data has been reformatted for display purposes. Eligibility criteria have been parsed into inclusion/exclusion sections. Location data has been geocoded to enable distance-based search. For the authoritative and most current information, please visit ClinicalTrials.gov.

Neither the United States Government nor Clareo Health make any warranties regarding the data. Check ClinicalTrials.gov frequently for updates.

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