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| ID | Type | Description | Link |
|---|---|---|---|
| REFLECTIONS B739-01 |
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This study is to prove that the handling (also referred to as pharmacokinetics) of the following drugs PF-06439535, Avastin® (bevacizumab) that is licensed for use in the United States (bevacizumab-US) and Avastin® (bevacizumab) obtained from Europe (bevacizumab-EU) is similar in healthy male volunteers after receiving a single intravenous dose of either drugs.
During the course of the study, the similarity in pharmacokinetics will be assessed by sampling the levels of drug in the blood, and by comparing these levels among the different administration arms of PF-06439535, bevacizumab-US and bevacizumab-EU. Safety, tolerability, and immunologic response to the administered drugs will also be evaluated throughout.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| A = PF-06439535 | Experimental | Intervention Description: Sterile vial 400mg, single-dose 5mg/kg administered as 90-minute infusion on day 1. |
|
| B = Bevacizumab-EU | Active Comparator | Intervention Description: Sterile vial 400mg, single-dose 5mg/kg administered as 90-minute infusion on day 1. |
|
| C = Bevacizumab-US | Active Comparator | Intervention Description: Sterile vial 400mg, single-dose 5mg/kg administered as 90-minute infusion on day 1. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| PF-06439535 | Biological | Solution for intravenous infusion, single dose of 5mg/kg, administered as 90-minute infusion. |
|
| Measure | Description | Time Frame |
|---|---|---|
| Maximum Observed Plasma Concentration (Cmax) | Day 1 - Day 71 | |
| Area Under the Curve from Time Zero to end of dosing interval (AUCtau) | Day 1 - Day 71 | |
| Area Under the Curve From Time Zero to Extrapolated Infinite Time [AUC (0 - 8)] | AUC (0 - 8)= Area under the plasma concentration versus time curve (AUC) from time zero (pre-dose) to extrapolated infinite time (0 - 8). It is obtained from AUC (0 - t) plus AUC (t - 8). | Day 1 - Day 71 |
| Measure | Description | Time Frame |
|---|---|---|
| Systemic Clearance (CL) | Day 1 - Day 71 | |
| Terminal Disposition Half-Life (t1/2) | Day 1 - Day 71 | |
| Volume of Distribution at Steady State (Vss) |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Pfizer CT.gov Call Center | Pfizer | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Pfizer Investigational Site | South Miami | Florida | 33143 | United States |
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| Label | URL |
|---|---|
| To obtain contact information for a study center near you, click here. | View source |
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| ID | Term |
|---|---|
| D009369 | Neoplasms |
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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 | Solution for intravenous infusion, single dose of 5mg/kg, administered as 90-minute infusion. |
|
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| Avastin | Biological | Solution for intravenous infusion, single dose of 5mg/kg, administered as 90-minute infusion. |
|
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| Day 1 - Day 71 |
| Incidence of anti-bevacizumab antibodies (ADA), including neutralizing antibodies (Nab) | Day 1 - Day 71 or LSLV, whichever occurs later |
| D007162 |
| Immunoproteins |
| D001798 | Blood Proteins |
| D011506 | Proteins |
| D000602 | Amino Acids, Peptides, and Proteins |
| D012712 | Serum Globulins |
| D005916 | Globulins |