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.
Inclusion Criteria: 1. Previous completion of a carfilzomib study within 90 days prior to first dose of maintenance study drug. 2. Disease Assessments performed within 30 days prior to first dose of maintenance study drug. 3. Written informed consent in accordance with federal, local, and institutional guidelines 4. 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. 5. 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. Exclusion Criteria: 1. Administration of an intervening chemotherapy between the time of previous carfilzomib study termination and first dose of maintenance study drug. 2. Pregnant or lactating females 3. 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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