QUILT-3.030: Open Label Extension Study of Conatumumab and AMG 479
This trial is active, not recruiting.
|Conditions||advanced solid tumors, carcinoid, colorectal cancer, locally advanced, lymphoma, metastatic cancer, non-small cell lung cancer, sarcoma, solid tumors|
|Treatments||folfox6, conatumumab, ganitumab, bevacizumab|
|Targets||IGF1-R, TRAIL, VEGF|
|Start date||March 2011|
|End date||July 2017|
|Trial size||12 participants|
|Trial identifier||NCT01327612, 20101116, QUILT-3.030|
The purpose of this protocol is to allow continued treatment with conatumumab and/or AMG 479, with or without chemotherapy to subjects without disease progression whose previous studies were closed.
|United States||No locations recruiting|
|Other countries||No locations recruiting|
|Duarte, CA||Research Site||no longer recruiting|
|La Jolla, CA||Research Site||no longer recruiting|
|Denver, CO||Research Site||no longer recruiting|
|Tampa, FL||Research Site||no longer recruiting|
|Ann Arbor, MI||Research Site||no longer recruiting|
|Buffalo, NY||Research Site||no longer recruiting|
|Memphis, TN||Research Site||no longer recruiting|
|Houston, TX||Research Site||no longer recruiting|
|San Antonio, TX||Research Site||no longer recruiting|
|Ogden, UT||Research Site||no longer recruiting|
|Szczecin, Poland||Research Site||no longer recruiting|
|Barcelona, Spain||Research Site||no longer recruiting|
|Intervention model||parallel assignment|
To evaluate the safety profile, including adverse events and serious adverse events, of conatumumab, with or without co-therapy, or AMG 479.
time frame: Two to three years
All participants at least 18 years old.
Inclusion Criteria: - 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 Exclusion Criteria: - 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
|Official title||A Phase 2 Open Label Extension Study of Conatumumab and AMG 479|
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