At a glance
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A Phase 2 Open Label Extension Study of Conatumumab and AMG 479
In Brief
A Phase 2 clinical trial evaluating Modified FOLFOX6, Conatumumab, and 2 other interventions for Advanced Solid Tumors and 8 related conditions. Completed, enrolled 12 participants across 12 sites in 3 countries.
Detailed Summary
The purpose of this protocol is to allow continued treatment with conatumumab and/or ganitumab, with or without chemotherapy, to participants who completed a separate Amgen-sponsored conatumumab or ganitumab study without disease progression whose previous studies were closed.
Study Details
Timeline
Interventions
The mFOLFOX6 regimen is a combination therapy of oxaliplatin 85 mg/m² administered as a 2-hour intravenous (IV) infusion on day 1 and leucovorin 400 mg/m² racemate or 200 mg/m² levo-leucovorin administered as a 2-hour infusion on day 1, followed by a loading dose of 5-fluorouracil (5-FU) 400 mg/m² IV bolus administered on day 1, then 5-FU 2400 mg/m² via ambulatory pump administered for a period of 46 to 48 hours every 14 days.
Administered by intravenous infusion Q2W or Q3W.
Administered by intravenous infusion Q3W or Q4W.
Administered at a dose of 5 mg/kg by intravenous infusion on day 1 of each 14 day cycle.