A Study of Carfilzomib Maintenance 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: January 8, 2013
Last verified: January 2013
This is a multi-center, open-label, Phase 2 study of carfilzomib to monitor the safety and efficacy of a maintenance therapy schedule for subjects who previously completed a primary carfilzomib treatment study. Only subjects who have achieved and maintained a response of at least stable disease (SD) through to completion of the prior carfilzomib study will be eligible for the current maintenance 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 Carfilzomib Maintenance Therapy in Subjects Previously Enrolled in Carfilzomib Treatment Protocols
Primary Outcome Measures:
- evaluate the safety and efficacy of a long-term, twice weekly, every other week carfilzomib in subjects who have achieved and maintained a response to the completion of a previous carfilzomib treatment study [ Time Frame: Assessments occur during cycle 1, cycle 2, cycle 3, and every 3 cycles thereafter. ] [ 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 14 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.
Please refer to this study by its ClinicalTrials.gov identifier: NCT00884312
Onyx Therapeutics, Inc.
No publications provided
||Onyx Pharmaceuticals ( Onyx Therapeutics, Inc. )
History of Changes
|Other Study ID Numbers:
|Study First Received:
||April 16, 2009
||January 8, 2013
||United States: Food and Drug Administration
Keywords provided by Onyx Pharmaceuticals:
Additional relevant MeSH terms:
ClinicalTrials.gov processed this record on May 23, 2013
Neoplasms, Plasma Cell
Neoplasms by Histologic Type
Blood Protein Disorders
Immune System Diseases