Back to Search Results
Study Complete
Sponsor ID
PX-171-010

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

Sponsor ID
PX-171-010
Clinicaltrials.gov ID
NCT00884312
EUCTIS ID
N/A
EudraCT ID
N/A
Contact Us

Study Details

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.

Additional Study Details

Phase
Phase 2
Product
carfilzomib
Type
Interventional
Masking
None (Open Label)
Enrollment
101
Additional Study Details

Protocol Summary

Primary Outcome Measures

To evaluate the safety and efficacy of long-term or continuing carfilzomib treatment in subjects who have completed previous carfilzomib treatment.

Timeframe: Assessments occur every 3 cycles

Secondary Outcome Measures
Not Available

Locations

Location
Status
Contact Us
Location
Pinnacle Oncology Hematology
Scottsdale, AZ, United States, 85258
Status
Completed
Location
Washington University School of Medicine
St. Louis, Missouri, United States, 63110-1093
Status
Completed
Location
John Theurer Cancer Center at Hackensack UMC
Hackensack, New Jersey, United States, 07601
Status
Completed
Location
Winship Cancer Institute - Emory University
Atlanta, Georgia, United States, 30322
Status
Completed
Location
University of California Medical Center
San Francisco, California, United States, 94143
Status
Completed
Location
City of Hope National Medial Center
Duarte, California, United States, 91010
Status
Completed
Showing {first} - {last} of {total} Results
Study Info
Age
18+ years
Condition
  • Multiple Myeloma
    • Show more
  • Solid Tumor
    • Sex
    All
    Trial Dates
    Apr 2009 - May 2017
    Inclusion and Exclusion 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.