A Study Comparing the Efficacy and Safety of Vanucizumab and FOLFOX With Bevacizumab and FOLFOX in Participants With Untreated Metastatic Colorectal Cancer

Conditions

• Colorectal Cancer

Eligibility Criteria

Sex

ALL

Age

18 Years - N/A

Healthy Volunteers

Not accepted

Interventions

• 5-FU — DRUG
  5-FU will be administered according to dose and schedule described in respective arm.
• Bevacizumab — DRUG
  Bevacizumab will be administered according to dose and schedule described in respective arm.
• Folinic acid — DRUG
  Folinic acid will be administered according to dose and schedule described in respective arm.
• Oxaliplatin — DRUG
  Oxaliplatin will be administered according to dose and schedule described in respective arm.
• Vanucizumab — DRUG
  Vanucizumab will be administered according to dose and schedule described in respective arm.

Study Details

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.

Key Dates

First listed

May 19, 2014

Start date

Jun 30, 2014

Status verified

Mar 2020

Primary completion

Jul 29, 2016

Completion

Feb 1, 2017

Study Design

Enrollment

197 participants (actual)

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Arms

• Experimental: Part 1 (Induction): Vanucizumab + mFOLFOX-6
  Participants will receive vanucizumab at a dose of 2000 milligram (mg) as intravenous (IV) infusion; oxaliplatin at a dose of 85 mg per meter-squared (mg/m\^2) as IV infusion; folinic acid at a dose of 400 mg/m\^2 as IV infusion; and 5-FU at a dose of 400 mg/m\^2 as starting IV bolus followed by 2400 mg/m\^2 as IV infusion every 2 weeks for up to 8 cycles (approximately 4 months).
• Experimental: Part 1 (Maintenance): Vanucizumab + 5-FU + Folinic acid
  Participants will receive vanucizumab at a dose confirmed during induction as IV infusion; folinic acid at a dose of 400 mg/m\^2 as IV infusion; and 5-FU at a dose of 400 mg/m\^2 as starting IV bolus followed by 2400 mg/m\^2 as IV infusion every 2 weeks until disease progression, unacceptable toxicities, consent withdrawal or Investigator's decision for a maximum of 24 months.
• Active Comparator: Part 2 (Induction): Bevacizumab + mFOLFOX-6
  Participants will receive bevacizumab at a dose of 5 milligram per kilogram (mg/kg) as IV infusion; oxaliplatin at a dose of 85 mg/m\^2 as IV infusion; folinic acid at a dose of 400 mg/m\^2 as IV infusion; and 5-FU at a dose of 400 mg/m\^2 as starting IV bolus followed by 2400 mg/m\^2 as IV infusion every 2 weeks for up to 8 cycles (approximately 4 months).
• Experimental: Part 2 (Induction): Vanucizumab + mFOLFOX-6
  Participants will receive vanucizumab at a dose confirmed during part 1 as IV infusion; oxaliplatin at a dose of 85 mg/m\^2 as IV infusion; folinic acid at a dose of 400 mg/m\^2 as IV infusion; and 5-FU at a dose of 400 mg/m\^2 as starting IV bolus followed by 2400 mg/m\^2 as IV infusion every 2 weeks for up to 8 cycles (approximately 4 months).
• Active Comparator: Part 2 (Maintenance): Bevacizumab + 5-FU + Folinic acid
  Participants will receive bevacizumab at a dose of 5 mg/kg as IV infusion; folinic acid at a dose of 400 mg/m\^2 as IV infusion; and 5-FU at a dose of 400 mg/m\^2 as starting IV bolus followed by 2400 mg/m\^2 as IV infusion every 2 weeks until disease progression, unacceptable toxicities, consent withdrawal or Investigator's decision for a maximum of 24 months.
• Experimental: Part 2 (Maintenance): Vanucizumab + 5-FU + Folinic acid
  Participants will receive vanucizumab at a dose confirmed during part 1 as IV infusion; folinic acid at a dose of 400 mg/m\^2 as IV infusion; and 5-FU at a dose of 400 mg/m\^2 as starting IV bolus followed by 2400 mg/m\^2 as IV infusion every 2 weeks until disease progression, unacceptable toxicities, consent withdrawal or Investigator's decision for a maximum of 24 months.

Primary Outcome Measure

Progression-free Survival (PFS), Time to Event [ Time Frame: Baseline, every 8 weeks, up to approximately 29 months ]

Locations (14)

Find similar trials in Birmingham, AL

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