A Study of Extended Carfilzomib 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: December 6, 2013
Last verified: December 2013

April 16, 2009
December 6, 2013
April 2009
April 2014   (final data collection date for primary outcome measure)
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 ]
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 ]
Complete list of historical versions of study NCT00884312 on ClinicalTrials.gov Archive Site
Not Provided
Not Provided
Not Provided
Not Provided
 
A Study of Extended Carfilzomib Therapy in Subjects Previously Enrolled in Carfilzomib Treatment Protocols
An Open-Label, Single-Arm, Phase 2 Study of Extended Carfilzomib Therapy in Subjects Previously Enrolled in Carfilzomib Treatment Protocols

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.

Not Provided
Interventional
Phase 2
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Multiple Myeloma
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
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
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Active, not recruiting
100
April 2014
April 2014   (final data collection date for primary outcome measure)

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.
Both
18 Years and older
No
Contact information is only displayed when the study is recruiting subjects
United States,   Canada
 
NCT00884312
PX-171-010
No
Onyx Pharmaceuticals ( Onyx Therapeutics, Inc. )
Onyx Therapeutics, Inc.
Not Provided
Study Director: Kanya Rajangam, MD Onyx Therapeutics, Inc.
Onyx Pharmaceuticals
December 2013

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP