Open Label Extension Study of Conatumumab and Ganitumab (AMG 479)

Part of paid clinical trials in Duarte, California.

Sponsor
Amgen
Study ID
NCT01327612
Phase
PHASE2
Status
Completed

Conditions

Eligibility Criteria

Sex
ALL
Age
18 Years - N/A
Healthy Volunteers
Not accepted

Interventions

  • Modified FOLFOX6 — DRUG
    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.
  • Conatumumab — BIOLOGICAL
    Administered by intravenous infusion Q2W or Q3W.
  • Ganitumab — BIOLOGICAL
    Administered by intravenous infusion Q3W or Q4W.
  • Bevacizumab — BIOLOGICAL
    Administered at a dose of 5 mg/kg by intravenous infusion on day 1 of each 14 day cycle.

Study Details

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.

Key Dates

First listed
Apr 1, 2011
Start date
Mar 3, 2011
Status verified
Feb 2021
Primary completion
Feb 5, 2020
Completion
Feb 5, 2020

Study Design

Enrollment
12 participants (actual)
Allocation
NON_RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT

Arms

  • Experimental: Conatumumab Monotherapy
    Participants will continue to receive conatumumab every 2 weeks (Q2W) or every 3 weeks (Q3W) at the same dose and regimen as at the conclusion of the parent study.
  • Experimental: Conatumumab + Ganitumab
    Participants will receive conatumumab and ganitumab by intravenous infusion at the same dose and regimen as at the conclusion of the parent study.
  • Experimental: Ganitumab Monotherapy
    Participants will continue to receive ganitumab Q3W or every 4 weeks (Q4W) at the same dose and regimen as at the conclusion of the parent study.
  • Experimental: Conatumumab + mFOLFOX6 ± Bevacizumab
    Participants will continue to receive conatumumab by intravenous infusion in addition to modified FOLFOX6 chemotherapy with or without bevacizumab.

Primary Outcome Measure

Number of Participants With Adverse Events [ Time Frame: From first dose of study drug in the extension study to 30 days after last dose; median duration of treatment with conatumumab was 1190.5 days and 1163.0 days for ganitumab. ]

Locations (10)

FacilityCityStateZIPSite coordinators
Research SiteDuarteCalifornia91010-
Research SiteLa JollaCalifornia92093-0957-
Research SiteDenverColorado80218-
Research SiteTampaFlorida33612-
Research SiteAnn ArborMichigan48109-
Research SiteBuffaloNew York14263-
Research SiteMemphisTennessee38120-
Research SiteHoustonTexas77030-
Research SiteSan AntonioTexas78229-
Research SiteOgdenUtah84403-

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