Adults 21 to 50, male only, with Healthy. Patients with the condition only — healthy volunteers not accepted.
Results — posted to ClinicalTrials.gov
Per-arm endpoint measurements with 95% confidence intervals where reported. Source: trial results section.
Area Under the Concentration-time Curve of the Analyte in Plasma Over the Time Interval From 0 Extrapolated to Infinity (AUC0-∞).Primary· Pharmacokinetic samples were collected predose, just before the end of the infusion, 2, 4, and 8 hours after the start of the infusion
Area under the concentration-time curve of the analyte in plasma over the time interval from 0 extrapolated to infinity (AUC0-∞) is presented as adjusted geometric mean (gMean) and geometric coefficient of variation (%) (gCV%). Adjustment were made for treatment effect and weight.
Group
Value
95% CI
BI 695502 (T)
7013.010
± 19.52
United States (US)-Licensed Avastin® (R1)
7261.119
± 15.57
European Union (EU)-Approved Avastin® (R2)
7649.491
± 18.29
Area Under the Concentration-time Curve of the Analyte in Plasma Over the Time Interval From 0 to the Time of the Last Quantifiable Data Point (AUC0-tz)Secondary· Pharmacokinetic samples were collected predose, just before the end of the infusion, 2, 4, and 8 hours after the start of the infusion
Area under the concentration-time curve of the analyte in plasma over the time interval from 0 to the time of the last quantifiable data point is presented as adjusted geometric mean (gMean) and geometric coefficient of variation (%) (gCV%). Adjustment was made for treatment effect and weight.
Group
Value
95% CI
BI 695502 (T)
6570.047
± 20.68
United States (US)-Licensed Avastin® (R1)
6639.315
± 18.46
European Union (EU)-Approved Avastin® (R2)
7167.313
± 19.72
Maximum Measured Concentration of the Analyte in Plasma (Cmax)Secondary· Pharmacokinetic samples were collected predose, just before the end of the infusion, 2, 4, and 8 hours after the start of the infusion.
Maximum measured concentration of the analyte in plasma (Cmax) is presented as adjusted geometric mean (gMean) and geometric coefficient of variation (%) (gCV%). Adjustment was made for treatment effect and weight.
Group
Value
95% CI
BI 695502 (T)
23.783
± 16.11
United States (US)-Licensed Avastin® (R1)
23.425
± 25.15
European Union (EU)-Approved Avastin® (R2)
25.505
± 15.18
Adverse events — posted to ClinicalTrials.gov
Time frame: From first drug administration to end of trial; up to 99 days..
Reporting threshold: 5%.
Adverse-event reports describe events observed during the trial — not all are caused by the drug.
This trial will investigate the pharmacokinetics and safety of BI 695502 and to establish pharmacokinetic biosimilarity of BI 695502 compared to bevacizumab.
Publications & conference data
3 peer-reviewed publications reference this trial (live from Europe PMC):
NCT02776683 — Open-label, Single Arm Trial of BI 695502 in Patients With Previously Untreated Metastatic Colorectal Cancer
· Phase 3
· completed
NCT02272413 — Phase III Trial BI 695502 Plus Chemotherapy vs. Avastin® Plus Chemotherapy in Patients With Lung Cancer
· Phase 3
· completed
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Publications: Europe PMC API search by NCT ID, retrieved 10 June 2026
Drug + disease cross-links: matched in real time against Drug Landscape's normalised drug + company + condition tables
Sponsor: as reported to ClinicalTrials.gov by Boehringer Ingelheim
Last refreshed: 8 November 2019
Drug Landscape aggregates and links these public records for informational use only. Always verify against the primary source before clinical or regulatory decisions. Canonical URL: https://druglandscape.com/trial/NCT01608087.