A Study Comparing the Efficacy and Safety of Vanucizumab and FOLFOX With Bevacizumab and FOLFOX in Participants With Untreated Metastatic Colorectal Cancer
TerminatedPhase 2Results postedLast updated 25 March 2020
What this trial tests
Phase 2 trial testing 5-FU in Colorectal Cancer in 197 participants. Terminated before completion.
18 and older, any sex, with Colorectal Cancer. 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.
Progression-free Survival (PFS), Time to EventPrimary· Baseline, every 8 weeks, up to approximately 29 months
Efficacy of vanucizumab was evaluated in terms of PFS as Investigator-Assessed Using Response Evaluation Criteria in Solid Tumors Version 1.1 (RECIST v1.1). PFS was defined as the time between randomization and the date of first documented disease progression or death from any cause on study, whichever occurred first. Death on study was defined as death from any cause within 30 days of the last study treatment.
Group
Value
95% CI
Vanucizumab + mFOLFOX-6
338.0
312.0 – 381.0
Bevacizumab + mFOLFOX-6
309.0
284.0 – 352.0
Percentage of Participants With Objective Response (ORR) as Assessed Using RECIST v. 1.1Secondary· Baseline (within 28 days prior to Day 1), then every 8 weeks until progressive disease (PD), start of other anticancer therapy, withdrawal of consent, or death (up to approximately 29 months)
Efficacy of vanucizumab was evaluated in terms of Percentage of Participants With ORR as Investigator-Assessed Using RECIST v. 1.1. Best Overall Confirmed Response.
Group
Value
95% CI
Safety Run-In
62.5
34.3 – 90.6
Vanucizumab + mFOLFOX-6
43.6
33.59 – 53.64
Bevacizumab + mFOLFOX-6
51.6
41.53 – 61.63
Duration of Objective Response, as Assessed Using RECIST v. 1.1Secondary· Baseline (within 28 days prior to Day 1), then every 8 weeks until PD, start of other anticancer therapy, withdrawal of consent, or death (up to approximately 29 months)
Efficacy of vanucizumab was evaluated in terms of duration of objective response as assessed using RECIST v. 1.1. This was computed using the PFS definition with death on study (deaths that occurred outside the 30 days window from the last study treatment are excluded).
Group
Value
95% CI
Vanucizumab + mFOLFOX-6
342
274 – 510
Bevacizumab + mFOLFOX-6
304
220 – 366
Overall Survival (OS)Secondary· Baseline until death from any cause (maximum up to approximately 3.5 years)
Efficacy of vanucizumab was evaluated in terms of OS as the time from randomization until death from any cause. 99999 = data not estimable due to the low number of deaths.
Group
Value
95% CI
Vanucizumab + mFOLFOX-6
746.0
687.0 – NA
Bevacizumab + mFOLFOX-6
NA
723.0 – NA
Percentage of Participants With Adverse Events (AEs)Secondary· Up to approximately 29 months
Safety is evaluated in terms of percentage of participants with at least one serious adverse event and percentage of participants with at least one adverse event.
Serious Adverse events
Group
Value
95% CI
Safety Run-In
37.5
Vanucizumab + mFOLFOX-6
49.5
Bevacizumab + mFOLFOX-6
43.2
Adverse events
Group
Value
95% CI
Safety Run-In
100
Vanucizumab + mFOLFOX-6
100.0
Bevacizumab + mFOLFOX-6
100.0
Number of Participants With Human Anti-human Antibodies (HAHAs) Against VanucizumabSecondary· End of study (EoS, within 28 to 42 days after last dose, latest at 29 months)
Safety is evaluated in terms of number of participants with Human Anti-human Antibodies (HAHAs) Against Vanucizumab.
Group
Value
95% CI
Safety Run-In
2
Vanucizumab + mFOLFOX-6
1
Area Under the Plasma Concentration-Time Curve (AUC) of VanucizumabSecondary· Cycles 1 and 8 of parts 1 and 2
PK profile of vanucizumab was evaluated in terms of AUC
Cycle 1
Group
Value
95% CI
Safety Run-In
73600
± 20.7
Vanucizumab + mFOLFOX-6
63500
± 27.2
Cycle 8
Group
Value
95% CI
Safety Run-In
112000
± 11.2
Vanucizumab + mFOLFOX-6
82100
± 31.6
Maximum Observed Plasma Concentration (Cmax) of VanucizumabSecondary· Cycles 1 and 8 of parts 1 and 2
PK profile of vanucizumab was evaluated in terms of Cmax
Cycle 1
Group
Value
95% CI
Safety Run-In
463
± 18.5
Vanucizumab + mFOLFOX-6
500
± 26.3
Cycle 8
Group
Value
95% CI
Safety Run-In
685
± 17.6
Vanucizumab + mFOLFOX-6
794
± 38.2
Minimum Observed Plasma Concentration (Clast) of VanucizumabSecondary· Cycles 1 and 8 of parts 1 and 2
PK profile of vanucizumab was evaluated in terms of Clast
Cycle 1
Group
Value
95% CI
Vanucizumab + mFOLFOX-6
103
± 67.2
Cycle 8
Group
Value
95% CI
Vanucizumab + mFOLFOX-6
361
± 39.8
Time to Reach Cmax (Tmax) of VanucizumabSecondary· Cycles 1 and 8 of parts 1 and 2
PK profile of vanucizumab was evaluated in terms of Tmax
Cycle 1
Group
Value
95% CI
Safety Run-In
2.79
1.50 – 7.67
Vanucizumab + mFOLFOX-6
2.05
1.0 – 26.1
Cycle 8
Group
Value
95% CI
Safety Run-In
4.04
0.5 – 5.25
Vanucizumab + mFOLFOX-6
1.58
0.5 – 4.77
Plasma Terminal Half-Life (t1/2) of VanucizumabSecondary· Cycle 8
PK profile of vanucizumab was evaluated in terms of t1/2, values are reported for cycle 8 of both part 1 (safety run-in) and part 2 of the study.
Group
Value
95% CI
Safety Run-In
202
± 12.4
Vanucizumab + mFOLFOX-6
157
± 30.3
Plasma Clearance at Steady State (CLss) of VanucizumabSecondary· Cycle 8
PK profile of vanucizumab was evaluated in terms of CLss, values are reported for cycle 8 of both part 1 (safety run-in) and part 2 of the study.
Group
Value
95% CI
Safety Run-In
15.3
± 26.7
Vanucizumab + mFOLFOX-6
18.0
± 29.0
Adverse events — posted to ClinicalTrials.gov
Time frame: Up to 28 days after the last dose of study drug (maximum treatment time = approximately 29 months)..
Reporting threshold: 5%.
Adverse-event reports describe events observed during the trial — not all are caused by the drug.
This is a Phase 2 multicenter, randomized, parallel arms, double-blind study of vanucizumab to evaluate the efficacy and safety of vanucizumab in combination with oxaliplatin, folinic acid, and 5-fluorouracil (5-FU) (mFOLFOX-6) versus bevacizumab (Avastin) + mFOLFOX-6 in participants with previously untreated metastatic colorectal cancer (mCRC). The study consists of 2 parts: a safety run-in open-label, single-arm part (Part 1) and a randomized, parallel-arms, double-blind part (Part 2). During Part 1 at least 6 eligible participants will receive 2000 milligrams (mg) vanucizumab every 2 weeks + mFOLFOX-6 in order to confirm the dose and schedule that will be used in Part 2. In Part 2, all eligible participants will be randomized in a ratio of 1:1 to receive either mFOLFOX-6 + vanucizumab or mFOLFOX-6 + bevacizumab. Study treatment (induction and maintenance) will be given on Day 1 of each 14-day cycle. Induction therapy will consist of up to 8 cycles of mFOLFOX-6 plus either bevacizumab or vanucizumab. Maintenance therapy will consist of 5-fluorouracil and folinic acid plus either vanucizumab or bevacizumab for up to 24 months or until disease progression, unacceptable toxicity, Investigator decision or consent withdrawal, whichever occurs first.
Publications & conference data
8 peer-reviewed publications reference this trial (live from Europe PMC):
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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 Hoffmann-La Roche
Last refreshed: 25 March 2020
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/NCT02141295.