A Study of Carfilzomib Maintenance Therapy in Subjects Previously Enrolled in Carfilzomib Treatment Protocols

This study is ongoing, but not recruiting participants.

Sponsor:

Information provided by (Responsible Party):

Onyx Pharmaceuticals ( Onyx Therapeutics, Inc. )

ClinicalTrials.gov Identifier:

NCT00884312

First received: April 16, 2009

Last updated: January 8, 2013

Last verified: January 2013

History of Changes

Tracking Information
First Received Date ^ICMJE	April 16, 2009
Last Updated Date	January 8, 2013
Start Date ^ICMJE	April 2009
Estimated Primary Completion Date	April 2014 (final data collection date for primary outcome measure)
Current Primary Outcome Measures ^ICMJE (submitted: July 21, 2010)	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 ]
Original Primary Outcome Measures ^ICMJE (submitted: April 17, 2009)	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 [ Designated as safety issue: Yes ]
Change History	Complete list of historical versions of study NCT00884312 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures ^ICMJE	Not Provided
Original Secondary Outcome Measures ^ICMJE	Not Provided
Current Other Outcome Measures ^ICMJE	Not Provided
Original Other Outcome Measures ^ICMJE	Not Provided

Descriptive Information
Brief Title ^ICMJE	A Study of Carfilzomib Maintenance Therapy in Subjects Previously Enrolled in Carfilzomib Treatment Protocols
Official Title ^ICMJE	An Open-Label, Single-Arm, Phase 2 Study of Carfilzomib Maintenance Therapy in Subjects Previously Enrolled in Carfilzomib Treatment Protocols
Brief Summary	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.
Detailed Description	Not Provided
Study Type ^ICMJE	Interventional
Study Phase	Phase 2
Study Design ^ICMJE	Allocation: Non-Randomized Endpoint Classification: Safety/Efficacy Study Intervention Model: Single Group Assignment Masking: Open Label Primary Purpose: Treatment
Condition ^ICMJE	Multiple Myeloma
Intervention ^ICMJE	Drug: Carfilzomib IV push on Days 1, 2, 15, and 16 of a 28 day cycle (e.g., every other week) Other Names: PR-171 PR171
Study Arm (s)	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. Intervention: Drug: Carfilzomib
Publications *	Not Provided
* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.

Recruitment Information
Recruitment Status ^ICMJE	Active, not recruiting
Estimated Enrollment ^ICMJE	100
Estimated Completion Date	April 2014
Estimated Primary Completion Date	April 2014 (final data collection date for primary outcome measure)
Eligibility Criteria ^ICMJE	Inclusion Criteria: 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. Exclusion Criteria: 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.
Gender	Both
Ages	18 Years and older
Accepts Healthy Volunteers	No
Contacts ^ICMJE	Contact information is only displayed when the study is recruiting subjects
Location Countries ^ICMJE	United States, Canada

Administrative Information
NCT Number ^ICMJE	NCT00884312
Other Study ID Numbers ^ICMJE	PX-171-010
Has Data Monitoring Committee	No
Responsible Party	Onyx Pharmaceuticals ( Onyx Therapeutics, Inc. )
Study Sponsor ^ICMJE	Onyx Therapeutics, Inc.
Collaborators ^ICMJE	Not Provided
Investigators ^ICMJE	Not Provided
Information Provided By	Onyx Pharmaceuticals
Verification Date	January 2013
^ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP

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