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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
  Purpose

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.


Condition Intervention Phase
Multiple Myeloma
 Drug: Carfilzomib
 Phase 2

Study Type: Interventional
Study Design: Allocation: Non-Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: An Open-Label, Single-Arm, Phase 2 Study of Carfilzomib Maintenance Therapy in Subjects Previously Enrolled in Carfilzomib Treatment Protocols

Resource links provided by NLM:

Drug Information available for: Carfilzomib
U.S. FDA Resources

Further study details as provided by Onyx Pharmaceuticals:

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: 100
Study Start Date: April 2009
Estimated Study Completion Date: April 2014
Estimated Primary Completion Date: April 2014 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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.
 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

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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 14 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.
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00884312

  Show 23 Study Locations
Sponsors and Collaborators
Onyx Therapeutics, Inc.
  More Information

No publications provided

Responsible Party: Onyx Pharmaceuticals ( Onyx Therapeutics, Inc. )
ClinicalTrials.gov Identifier: NCT00884312     History of Changes
Other Study ID Numbers: PX-171-010
Study First Received: April 16, 2009
Last Updated: January 8, 2013
Health Authority: United States: Food and Drug Administration

Keywords provided by Onyx Pharmaceuticals:
Multiple myeloma
proteasome
Hematological
carfilzomib
PR-171

Additional relevant MeSH terms:
Multiple Myeloma
Neoplasms, Plasma Cell
Neoplasms by Histologic Type
Neoplasms
Hemostatic Disorders
Vascular Diseases
Cardiovascular Diseases
 Paraproteinemias
Blood Protein Disorders
Hematologic Diseases
Hemorrhagic Disorders
Lymphoproliferative Disorders
Immunoproliferative Disorders
Immune System Diseases

ClinicalTrials.gov processed this record on May 23, 2013