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A Study of Extended Carfilzomib Therapy for Patients Previously Enrolled in Carfilzomib Treatment Protocols

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ClinicalTrials.gov Identifier: NCT00884312
Recruitment Status : Completed
First Posted : April 20, 2009
Last Update Posted : March 13, 2018
Sponsor:
Information provided by (Responsible Party):
Amgen

Brief Summary:
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 patients who previously completed a primary carfilzomib treatment study.

Condition or disease Intervention/treatment Phase
Multiple Myeloma Solid Tumors Drug: Carfilzomib Phase 2

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 101 participants
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: An Open-Label, Single-Arm, Phase 2 Study of Extended Carfilzomib Therapy in Subjects Previously Enrolled in Carfilzomib Treatment Protocols
Actual Study Start Date : April 9, 2009
Actual Primary Completion Date : May 17, 2017
Actual Study Completion Date : May 17, 2017

Resource links provided by the National Library of Medicine

Drug Information available for: Carfilzomib
U.S. FDA Resources

Arm Intervention/treatment
Experimental: 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.
Drug: 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 Names:
  • PR-171
  • PR171
  • Krypolis®



Primary Outcome Measures :
  1. 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 ]


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Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00884312


  Hide Study Locations
Locations
United States, Arizona
Pinnacle Oncology Hematology
Scottsdale, Arizona, United States, 85258
United States, California
Tower Cancer Research Foundation
Beverly Hills, California, United States, 90211
City of Hope National Medial Center
Duarte, California, United States, 91010
University of California Medical Center
San Francisco, California, United States, 94143
United States, Colorado
Colorado Blood Cancer Institute
Denver, Colorado, United States, 80218
United States, Florida
H. Lee Moffitt Cancer Center & Research Institute
Tampa, Florida, United States, 33612
United States, Georgia
Winship Cancer Institute - Emory University
Atlanta, Georgia, United States, 30322
United States, Illinois
Northwestern University
Chicago, Illinois, United States, 60611
United States, Maryland
University of Maryland, Greenebaum Cancer Center
Baltimore, Maryland, United States, 21201
United States, Missouri
Washington University School of Medicine
Saint Louis, Missouri, United States, 63110-1093
United States, New Jersey
John Theurer Cancer Center at Hackensack UMC
Hackensack, New Jersey, United States, 07601
United States, New York
Weill Cornell Medical College
New York, New York, United States, 10021
Mount Sinai School of Medicine
New York, New York, United States, 10029
United States, Ohio
Gabrail Cancer Center Research
Canton, Ohio, United States, 44718
The Cleveland Clinic Foundation
Cleveland, Ohio, United States, 44195
United States, Pennsylvania
Abramson Cancer Center of the University of Pennsylvania
Philadelphia, Pennsylvania, United States, 19104
United States, Tennessee
Sarah Cannon Research Institute
Nashville, Tennessee, United States, 37203-1632
United States, Texas
Texas Oncology Cancer Center
Austin, Texas, United States, 78731
The University of Texas, MD Anderson Cancer Center
Houston, Texas, United States, 77030
Northwest Cancer Center
Houston, Texas, United States, 77090
United States, Washington
Fred Hutchinson Cancer Research Center
Seattle, Washington, United States, 98109
Canada, Ontario
University of Toronto, Princess Margaret Hospital
Toronto, Ontario, Canada, M5G 2M9
Canada, Quebec
Jewish General Hospital
Montreal, Quebec, Canada, H3t 1E2
Sponsors and Collaborators
Amgen
Investigators
Study Director: MD Amgen

Responsible Party: Amgen
ClinicalTrials.gov Identifier: NCT00884312     History of Changes
Other Study ID Numbers: PX-171-010
20130394 ( Other Identifier: Amgen Study ID )
First Posted: April 20, 2009    Key Record Dates
Last Update Posted: March 13, 2018
Last Verified: March 2018

Keywords provided by Amgen:
Multiple myeloma
proteasome
Hematological
carfilzomib
PR-171

Additional relevant MeSH terms:
Multiple Myeloma
Neoplasms, Plasma Cell
Neoplasms by Histologic Type
Neoplasms
Hemostatic Disorders
Vascular Diseases
Cardiovascular Diseases
Paraproteinemias
Blood Protein Disorders
Hematologic Diseases
Hemorrhagic Disorders
Lymphoproliferative Disorders
Immunoproliferative Disorders
Immune System Diseases