A clinical trial intended to compare safety and efficacy of two formulations in patients with metastatic Colorectal Cancer (mCRC).

• Register: CTRI
• Last refreshed on: 24 November 2021
• Main ID: CTRI/2014/08/004868
• Date of registration: 12-08-2014
• Prospective Registration: Yes
• Primary sponsor: MABXIENCE SA
• Public title: A clinical trial intended to compare safety and efficacy of two formulations in patients with metastatic Colorectal Cancer (mCRC).
• Scientific title: Open label randomized bioequivalence study to evaluate the pharmacokinetic (PK) and safety profile of Bevacizumab Biosimilar (BEVZ92) in combination with FOLFOX or FOLFIRI versus Bevacizumab (AVASTIN®) in combination with FOLFOX or FOLFIRI as first-line treatment in patients with metastatic ColoRectal Cancer (mCRC).
• Date of first enrolment: 25-08-2014
• Target sample size: 100
• Recruitment status: Completed
• URL: http://www.ctri.nic.in/Clinicaltrials/pmaindet2.php?trialid=9836
• Study type: Interventional
• Study design: Randomized, Parallel Group Trial; Method of generating randomization sequence:Computer generated randomization Method of allocation concealment:Centralized Blinding and masking:Open Label
• Phase: Phase 3

Countries of recruitment

Argentina, Brazil, India, Peru, Russian Federation, Ukraine

Contacts

• Name: Dr Chirag Shah
• Affiliation: Cliantha Research Limited

• Name: Dr Charu Gautam
• Affiliation: Cliantha Research Limited

Key inclusion & exclusion criteria

Inclusion criteria: 1. Patients must have signed an informed consent before any study related procedure or evaluation is performed.

2. Patients must be > 18 years of age.

3. Patient must not have had prior chemotherapy for advanced or metastatic disease. Patients could have received adjuvant chemotherapy or adjuvant chemo-radiotherapy.

4. Patient with mCRC for whom bio-chemotherapy is indicated.

5. Patients must have at least one measurable non-irradiated site of disease according to RECIST criteria.

6. Minimum of 4 weeks since any major surgery, completion of radiation, or completion of all prior systemic anticancer therapy.

7. ECOG performance status <= 2.
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 leptomeningeal 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.

Age minimum:
Age maximum:
Gender:

Health Condition(s) or Problem(s) studied

Health Condition 1: null- patients with metastatic ColoRectal Cancer (mCRC)

Intervention(s)

Intervention1: Bevacizumab
Biosimilar: Bevacizumab (5 mg/kg) will be administered initially as a 90-minute infusion
Control Intervention1: AVASTIN (Roche/Genentech: Avastin® (5 mg/kg) will be administered initially as a 90-minute infusion

Primary Outcome(s)

To compare the PK profile of Bevacizumab and Avastin®, both administered in combination with FOLFOX (any) or FOLFIRI.Timepoint: Cycle 1:

0 h(pre-infusion), end of infusion; 1 h, 2 h, 6 h, 24 h (D2), 48h (D3),72h (D4), 120h (D6), 168 h (D8) & 240 h (D11) after end of infusion.Cycle 2- Cycle 5: 0 h(pre-infusion), end of infusion on D1 of Cycles 2 and 5

Cycle 7:

0h, end of infusion; 1 h, 2 h, 6 h after end of infusion on

D1 and thereafter one sample at 24 h (D2), 48 h (D3), 72 h (D4), 120 h

(D6), 168 h (D8), 240 h (D11) after end of infusion

(Cycle 7)and 336 h(D15, just before the start of the bevacizumab of Cycle 8

Secondary Outcome(s)

Comparation the safety profile of Bevacizumab and Avastin®, both

administered in combination with FOLFOX (any) or FOLFIRI.Timepoint: At the End of study. i.e. After 12 months.

Secondary ID(s)

BEVZ92-A-01-13, Version 1.0 dated 23 Aug 14

Source(s) of Monetary Support

Sponsor: MABXIENCE SA

Ethics review

Status: Approved
Approval date: 05/05/2014
Contact:

Institutional Ethics Committee, Sri RamaChandra Medical Centre

Status: Not Approved
Approval date:
Contact:

Human Ethics Committee, H M Patel Centre for Medical Care and Education, Gokal Nagar, Karamsad

Status: Not Approved
Approval date:
Contact:

Human Ethics Committee, Regional Cancer Center, Medical College Campus, Trivendrum

Status: Not Approved
Approval date:
Contact:

Institutional Ethics Committee, Mumbai