A Study of Extended Carfilzomib Therapy for Patients Previously Enrolled in Carfilzomib Treatment Protocols
NCT ID: NCT00884312
Last Updated: 2018-05-14
Study Results
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View full resultsBasic Information
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COMPLETED
PHASE2
101 participants
INTERVENTIONAL
2009-04-09
2017-05-17
Brief Summary
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Detailed Description
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Conditions
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Study Design
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NA
SINGLE_GROUP
TREATMENT
NONE
Study Groups
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Carfilzomib
Participants received carfilzomib administered intravenously, using the same method, frequency, and dose level as in the last cycle of the participant's previous carfilzomib study. Treatment was continued until confirmation of disease progression, diagnosis of new malignancy, unacceptable toxicity, investigator discretion, voluntary withdrawal, or commercial availability of carfilzomib.
Carfilzomib
Carfilzomib dose levels ranged from 11 to 27 mg/m² for 2- to 10-minute infusions and 36 to 56 mg/m² for 30-minute infusions. Carfilzomib doses were administered on days 1, 2, 8, 9, 15, and 16 of a 28-day cycle. Dose level reduction to a minimum dose of 11 mg/m² for toxicity was permitted.
Interventions
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Carfilzomib
Carfilzomib dose levels ranged from 11 to 27 mg/m² for 2- to 10-minute infusions and 36 to 56 mg/m² for 30-minute infusions. Carfilzomib doses were administered on days 1, 2, 8, 9, 15, and 16 of a 28-day cycle. Dose level reduction to a minimum dose of 11 mg/m² for toxicity was permitted.
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
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
2. Pregnant or lactating females
3. Diagnosis of a new malignancy of a different tumor type.
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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Pinnacle Oncology Hematology
Scottsdale, Arizona, United States
Tower Cancer Research Foundation
Beverly Hills, California, United States
City of Hope National Medial Center
Duarte, California, United States
University of California Medical Center
San Francisco, California, United States
Colorado Blood Cancer Institute
Denver, Colorado, United States
H. Lee Moffitt Cancer Center & Research Institute
Tampa, Florida, United States
Winship Cancer Institute - Emory University
Atlanta, Georgia, United States
Northwestern University
Chicago, Illinois, United States
University of Maryland, Greenebaum Cancer Center
Baltimore, Maryland, United States
Washington University School of Medicine
St Louis, Missouri, United States
John Theurer Cancer Center at Hackensack UMC
Hackensack, New Jersey, United States
Weill Cornell Medical College
New York, New York, United States
Mount Sinai School of Medicine
New York, New York, United States
Gabrail Cancer Center Research
Canton, Ohio, United States
The Cleveland Clinic Foundation
Cleveland, Ohio, United States
Abramson Cancer Center of the University of Pennsylvania
Philadelphia, Pennsylvania, United States
Sarah Cannon Research Institute
Nashville, Tennessee, United States
Texas Oncology Cancer Center
Austin, Texas, United States
The University of Texas, MD Anderson Cancer Center
Houston, Texas, United States
Northwest Cancer Center
Houston, Texas, United States
Fred Hutchinson Cancer Research Center
Seattle, Washington, United States
University of Toronto, Princess Margaret Hospital
Toronto, Ontario, Canada
Jewish General Hospital
Montreal, Quebec, Canada
Countries
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Provided Documents
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Document Type: Study Protocol
Document Type: Statistical Analysis Plan
Other Identifiers
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20130394
Identifier Type: OTHER
Identifier Source: secondary_id
PX-171-010
Identifier Type: -
Identifier Source: org_study_id
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