A Study of Extended Carfilzomib Therapy in Subjects Previously Enrolled in Carfilzomib Treatment Protocols
This study is ongoing, but not recruiting participants.
Information provided by (Responsible Party):
Onyx Pharmaceuticals ( Onyx Therapeutics, Inc. )
First received: April 16, 2009
Last updated: December 6, 2013
Last verified: December 2013
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.
||Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
||An Open-Label, Single-Arm, Phase 2 Study of Extended Carfilzomib Therapy in Subjects Previously Enrolled in Carfilzomib Treatment Protocols
Primary Outcome Measures:
- 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 ] [ Designated as safety issue: Yes ]
| Estimated Enrollment:
| Study Start Date:
| Estimated Study Completion Date:
| Estimated Primary Completion Date:
||April 2014 (Final data collection date for primary outcome measure)
Long-term or continuing carfilzomib dose
To evaluate the safety and efficacy of long-term or continuing carfilzomib dosing in subjects who have completed a previous carfilzomib treatment.
IV push on Days 1, 2, 15, and 16 of a 28 day cycle (e.g., every other week)
|Ages Eligible for Study:
||18 Years and older
|Genders Eligible for Study:
|Accepts Healthy Volunteers:
- 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.
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study.
To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below.
For general information, see Learn About Clinical Studies.
Please refer to this study by its ClinicalTrials.gov identifier: NCT00884312
Onyx Therapeutics, Inc.
||Kanya Rajangam, MD
||Onyx Therapeutics, Inc.
No publications provided
||Onyx Pharmaceuticals ( Onyx Therapeutics, Inc. )
History of Changes
|Other Study ID Numbers:
|Study First Received:
||April 16, 2009
||December 6, 2013
||United States: Food and Drug Administration
Keywords provided by Onyx Pharmaceuticals:
Additional relevant MeSH terms:
ClinicalTrials.gov processed this record on August 21, 2014
Neoplasms, Plasma Cell
Neoplasms by Histologic Type
Blood Protein Disorders
Immune System Diseases