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Decision of the Sponsor
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The purpose of this to assess pharmacokinetic bioequivalence between two bevacizumab products, RPH-001 (TRPHARM) and EU sourced Avastin® (Roche), after single IV administration at 5 mg/kg fixed dose.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| RPH-001 | Experimental | A single dose of RPH-001 will be administered (IV) 5 mg/kg dose . |
|
| EU sourced Avastin® | Active Comparator | A single dose of Avastin® will be administered (IV) 5 mg/kg dose . |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| RPH001 | Biological | Avastin® has been approved for treatment of various cancers in many countries of the world including the USA, EU countries, and Turkey. In Turkey, Avastin® is approved with a different trade name, Altuzan®, for treatment of metastatic colorectal cancer. |
| Measure | Description | Time Frame |
|---|---|---|
| Maximum plasma concentration | Cmax | Until 100 days after administration |
| Area under concentration-time curve from time zero to the last sampling time | Area Under the Curve - AUC(0-t) | Until 100 days after administration |
| Area under concentration-time curve from time zero to infinity | Area Under the Curve - AUC(0-∞) | Until 100 days after administration |
| Measure | Description | Time Frame |
|---|---|---|
| Concentration-time profiles | RPH-001 and Avastin® | Until 100 days after administration |
| Time to maximum concentration (Tmax) | RPH-001 and Avastin® |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Zafer Sezer, PHD | IKUM | Principal Investigator |
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| ID | Term |
|---|---|
| D000068258 | Bevacizumab |
| ID | Term |
|---|---|
| D061067 | Antibodies, Monoclonal, Humanized |
| D000911 | Antibodies, Monoclonal |
| D000906 | Antibodies |
| D007136 | Immunoglobulins |
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| Avastin® | Biological | R-Pharm created a biological analog of Avastin®, RPH-001. RPH-001 and Avastin® have similar physicochemical properties, pharmacokinetic profile and affinity to human vascular endothelial growth factor, similar toxicity and efficacy confirmed by preclinical study results. |
|
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| Until 100 days after administration |
| Terminal elimination half-life (t½) | RPH-001 and Avastin® | Until 100 days after administration |
| Terminal elimination rate constant (λz) | RPH-001 and Avastin® | Until 100 days after administration |
| Apparent volume of distribution (Vz) | RPH-001 and Avastin® | Until 100 days after administration |
| Clearance (CL) | Until 100 days after administration |
| Volume of distribution at steady state (Vss) | Until 100 days after administration |
| Nature, frequency, severity and relationship to study drug of recorded adverse events | Until 100 days after administration |
| Physical examination | Until 100 days after administration |
| Heart rate | Until 100 days after administration |
| Blood Pressure | Until 100 days after administration |
| Respiratory rate | Until 100 days after administration |
| Oxygen saturation | Until 100 days after administration |
| Body temperature | Until 100 days after administration |
| ECG | Until 100 days after administration |
| Clinical laboratory tests | Until 100 days after administration |
| Anti-drug-antibody (ADA) | Until 100 days after administration |
| Neutralizing antibody (NAb) | Until 100 days after administration |
| D007162 |
| Immunoproteins |
| D001798 | Blood Proteins |
| D011506 | Proteins |
| D000602 | Amino Acids, Peptides, and Proteins |
| D012712 | Serum Globulins |
| D005916 | Globulins |