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

Information source: mAbxience S.A
ClinicalTrials.gov processed this data on August 20, 2015
Link to the current ClinicalTrials.gov record.

Condition(s) targeted: Metastatic Colorectal Cancer.

Intervention: Bevacizumab biosimilar (BEVZ92) (Drug); Avastin® (bevacizumab, reference product) (Drug)

Phase: Phase 1

Status: Recruiting

Sponsored by: mAbxience S.A

Overall contact:
Pilar Sanjuan Sanz, MSc, Phone: + 34 91 771 15 00, Ext: 9575, Email: pilar.sanjuan@mabxience.es

Summary

This is a multicenter, open label, randomized bioequivalence study of BEVZ92 (bevacizumab biosimilar) and Avastin with 2 parallel arms to compare the 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.

Clinical Details

Official title: Open Label Randomized Bioequivalence Study to Evaluate the PK and Safety Profile of Bevacizumab Biosimilar (BEVZ92) With FOLFOX or FOLFIRI vs Bevacizumab (AVASTIN) With FOLFOX or FOLFIRI in First-line Treatment for mCRC Patients

Study design: Allocation: Randomized, Endpoint Classification: Bio-equivalence Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Primary outcome: To compare the PK profile of BEVZ92 and Avastin®, both administered in combination with FOLFOX (any) or FOLFIRI

Secondary outcome: Safety, immunogenicity and efficacy profile

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

Minimum age: 18 Years. Maximum age: N/A. Gender(s): Both.

Criteria:

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. 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. 11. Use of an effective form of contraception during the study (for subjects of childbearing potential and their partners). 12. Life expectation ≥ 3 months 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 11. Patients with serious non-healing wound, ulcer, bone fracture, or with a major surgical procedure, or significant traumatic injury within 4 weeks prior to randomization 12. Patients with clinical symptoms or signs of gastrointestinal obstruction that require parenteral hydration and/or nutrition. 13. Patients with history of abdominal fistula, gastrointestinal perforation, or intra-abdominal abscess within the past 6 months prior to randomization. 14. Patients with history of hypersensitivity to any of the study drugs or ingredients.

Locations and Contacts

Pilar Sanjuan Sanz, MSc, Phone: + 34 91 771 15 00, Ext: 9575, Email: pilar.sanjuan@mabxience.es

Hospital de Gastroenterologia "Dr. Carlos Bonorino Udaondo", Buenos Aires, Argentina; Recruiting

Instituto Oncológico de Rosario, Rosario, Argentina; Recruiting

Fundaçáo Pio XII - Hospital do Cancer de Barretos, Barretos, Brazil; Recruiting

Hospital Caridade, Ijui, Brazil; Recruiting

Hospital Sao Lucas da Pucrs, Porto Alegre, Brazil; Not yet recruiting

Hosp. A.C Camargo, Sao Paolo, Brazil; Not yet recruiting

Instituto do Cancer del estado de S. Paulo (ICEPS ), Sao Paulo, Brazil; Recruiting

Centro de Pesquisa do Instituto Brasileiro de Controle do Câncer - IBCC, São Paulo, Brazil; Recruiting

Sri Ramachandra Hospital, Chennai, India; Recruiting

M S Patel Cancer Centre- Shree Krishna Hospital, Karamsand, India; Recruiting

Tata Hospital, Mumbai, India; Recruiting

Central India Canter Research Institute, Nagpur, India; Not yet recruiting

Curie Manavta Cancer Center, Nashik, India; Recruiting

Regional Cancer Center & Medical College, Thiruvananthapuram, India; Recruiting

Centro Oncológico Clara Campal, Madrid, Spain; Recruiting

Dnipropetrovsk City Multiple-discipline Clinical Hospital №4, Dnipropetrovsk, Ukraine; Recruiting

Kharkiv Regional Clinical Oncology Center, Kharkiv, Ukraine; Recruiting

Danylo Halytskiy Lviv National Medical University, Lviv, Ukraine; Recruiting

Additional Information

Starting date: October 2014
Last updated: August 11, 2015

Page last updated: August 20, 2015

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