Open Label Extension Study of Conatumumab and Ganitumab (AMG 479)
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.
Ask AI to explain this studyKey things to know
This describes the study’s primary purpose.
Plus 2 other study approaches.
These are broad labels—not an eligibility decision.
Checked against the public recordLast updated Feb 21, 2021 · Source: ClinicalTrials.gov
Ask the study team to confirm whether enrollment is open.
Interventional
Locations may change over time.
Study sponsor
What this study is about
- Purpose
- Treatment
- Study type
- Interventional
- Phase
- Phase 2
- Sponsor
- Amgen
- Interventions being studied
- Drug: Modified FOLFOX6; Biological: Conatumumab; Biological: Ganitumab; Biological: Bevacizumab
How this study is categorized
These labels come from structured fields and exact terms in the public record.
Who may be able to participate
The sponsor separates these requirements into two groups. You do not need to interpret them alone—use them to guide a conversation with the study team.
To be enrolled in this study, subjects must be currently enrolled in a prior Amgen-sponsored conatumumab or AMG 479 study and are eligible according to the parent study to receive their next dose of conatumumab (with or without co-therapy), or AMG 479 alone. Subjects must have their eligibility assessed for this study and be enrolled within 30 days of their last treatment on the parent protocol
- Discontinued from a conatumumab study due to an adverse event considered by the investigator to be related to conatumumab treatment, including intolerance to conatumumab
- 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
Important: This is the sponsor’s public criteria, not a determination of eligibility. The study team must review your individual situation.
U.S. locations
- Research SiteDuarte, California
- Research SiteLa Jolla, California
- Research SiteDenver, Colorado
- Research SiteTampa, Florida
- Research SiteAnn Arbor, Michigan
- Research SiteBuffalo, New York
- Research SiteMemphis, Tennessee
- Research SiteHouston, Texas
- Research SiteSan Antonio, Texas
- Research SiteOgden, Utah
- Research SiteSzczecin
- Research SiteBarcelona, Catalonia
Source and freshness
Processed from ClinicalTrials.gov. Last public update: Feb 21, 2021. Always confirm current availability with the study team.