Open Label Extension Study of Conatumumab and Ganitumab (AMG 479)
NCT ID: NCT01327612
Last Updated: 2021-02-21
Study Results
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View full resultsBasic Information
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COMPLETED
PHASE2
12 participants
INTERVENTIONAL
2011-03-03
2020-02-05
Brief Summary
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Detailed Description
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Conditions
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Study Design
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NON_RANDOMIZED
PARALLEL
TREATMENT
NONE
Study Groups
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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.
Conatumumab
Administered by intravenous infusion Q2W or Q3W.
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.
Conatumumab
Administered by intravenous infusion Q2W or Q3W.
Ganitumab
Administered by intravenous infusion Q3W or Q4W.
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.
Ganitumab
Administered by intravenous infusion Q3W or Q4W.
Conatumumab + mFOLFOX6 ± Bevacizumab
Participants will continue to receive conatumumab by intravenous infusion in addition to modified FOLFOX6 chemotherapy with or without bevacizumab.
Modified FOLFOX6
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
Administered by intravenous infusion Q2W or Q3W.
Bevacizumab
Administered at a dose of 5 mg/kg by intravenous infusion on day 1 of each 14 day cycle.
Interventions
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Modified FOLFOX6
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
Administered by intravenous infusion Q2W or Q3W.
Ganitumab
Administered by intravenous infusion Q3W or Q4W.
Bevacizumab
Administered at a dose of 5 mg/kg by intravenous infusion on day 1 of each 14 day cycle.
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
Subjects must have their eligibility assessed for this study and be enrolled within 30 days of their last treatment on the parent protocol
Exclusion Criteria
* Subjects determined to have disease progression during their participation in the parent Amgen study
* Woman or man with partner of childbearing potential not consenting to use adequate contraceptive precautions ie, double barrier contraceptive methods (eg, diaphragm plus condom), or abstinence during the course of the study and for 6 months after the last dose of protocol-specified therapy administration
* Subject is pregnant or breast feeding, or planning to become pregnant within 6 months after the last dose of protocol-specified therapy administration
* Male subject with a pregnant partner who is not willing to use a condom during treatment and for an additional 6 months after the last dose of protocol-specified therapy administration
* Subject has previously entered this study
* Subject will not be available for protocol required study visits, to the best of the subject and investigator's knowledge
* Subject has any kind of disorder that, in the opinion of the investigator, may compromise the ability of the subject to give written informed consent and/or to comply with all required study procedures
18 Years
ALL
No
Sponsors
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Amgen
INDUSTRY
Responsible Party
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Principal Investigators
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MD
Role: STUDY_DIRECTOR
Amgen
Locations
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Research Site
Duarte, California, United States
Research Site
La Jolla, California, United States
Research Site
Denver, Colorado, United States
Research Site
Tampa, Florida, United States
Research Site
Ann Arbor, Michigan, United States
Research Site
Buffalo, New York, United States
Research Site
Memphis, Tennessee, United States
Research Site
Houston, Texas, United States
Research Site
San Antonio, Texas, United States
Research Site
Ogden, Utah, United States
Research Site
Szczecin, , Poland
Research Site
Barcelona, Catalonia, Spain
Countries
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Provided Documents
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Document Type: Study Protocol
Document Type: Statistical Analysis Plan
Related Links
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AmgenTrials clinical trials website
Other Identifiers
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2010-022270-14
Identifier Type: EUDRACT_NUMBER
Identifier Source: secondary_id
20101116
Identifier Type: -
Identifier Source: org_study_id
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