A Study of Extended Carfilzomib Therapy in Subjects Previously Enrolled in Carfilzomib Treatment Protocols
This trial is active, not recruiting.
|Sponsor||Onyx Therapeutics, Inc.|
|Start date||April 2009|
|End date||March 2017|
|Trial size||100 participants|
|Trial identifier||NCT00884312, PX-171-010|
This is a multi-center, open-label, Phase 2 study of carfilzomib to monitor the safety and efficacy of long-term or continuing carfilzomib therapy for subjects who previously completed a primary carfilzomib treatment study. Only subjects who have adequately completed a prior carfilzomib study will be eligible for the current study.
|United States||No locations recruiting|
|Other countries||No locations recruiting|
|Scottsdale, AZ||Pinnacle Oncology Hematology||no longer recruiting|
|Beverly Hills, CA||Tower Cancer Research Foundation||no longer recruiting|
|Duarte, CA||City of Hope National Medial Center||no longer recruiting|
|San Francisco, CA||University of California Medical Center||no longer recruiting|
|Denver, CO||Colorado Blood Cancer Institute||no longer recruiting|
|Tampa, FL||H. Lee Moffitt Cancer Center & Research Institute||no longer recruiting|
|Atlanta, GA||Winship Cancer Institute - Emory University||no longer recruiting|
|Chicago, IL||Northwestern University||no longer recruiting|
|Baltimore, MD||University of Maryland, Greenebaum Cancer Center||no longer recruiting|
|St. Louis, MO||Washington University School of Medicine||no longer recruiting|
|Hackensack, NJ||John Theurer Cancer Center at Hackensack UMC||no longer recruiting|
|New York, NY||Weill Cornell Medical College||no longer recruiting|
|New York, NY||Mount Sinai School of Medicine||no longer recruiting|
|Canton, OH||Gabrail Cancer Center Research||no longer recruiting|
|Cleveland, OH||The Cleveland Clinic Foundation||no longer recruiting|
|Philadelphia, PA||Abramson Cancer Center of the University of Pennsylvania||no longer recruiting|
|Nashville, TN||Sarah Cannon Research Institute||no longer recruiting|
|Austin, TX||Texas Oncology Cancer Center||no longer recruiting|
|Houston, TX||The University of Texas, MD Anderson Cancer Center||no longer recruiting|
|Houston, TX||Northwest Cancer Center||no longer recruiting|
|Seattle, WA||Fred Hutchinson Cancer Research Center||no longer recruiting|
|Toronto, Canada||University of Toronto, Princess Margaret Hospital||no longer recruiting|
|Montreal, Canada||Jewish General Hospital||no longer recruiting|
|Endpoint classification||safety/efficacy study|
|Intervention model||single group assignment|
To evaluate the safety and efficacy of long-term or continuing carfilzomib treatment in subjects who have completed previous carfilzomib treatment.
time frame: Assessments occur every 3 cycles
Male or female participants at least 18 years old.
- Previous completion of a carfilzomib study within 90 days prior to first dose of maintenance study drug.
- Disease Assessments performed within 30 days prior to first dose of maintenance study drug.
- Written informed consent in accordance with federal, local, and institutional guidelines
- Females of childbearing potential (FCBP)* must have a negative serum or urine pregnancy test, with a sensitivity of at least 50 mIU/mL, within 3 days prior to first dose of maintenance study drug.
- Subjects must agree to adhere to the study visit schedule and other study requirements and receive outpatient treatment and laboratory monitoring at the institution that administers the drug.
- Administration of an intervening chemotherapy between the time of previous carfilzomib study termination and first dose of maintenance study drug.
- Pregnant or lactating females
- Diagnosis of a new malignancy of a different tumor type.
|Official title||An Open-Label, Single-Arm, Phase 2 Study of Extended Carfilzomib Therapy in Subjects Previously Enrolled in Carfilzomib Treatment Protocols|
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