Overview

This trial is active, not recruiting.

Condition multiple myeloma
Treatment carfilzomib
Phase phase 2
Target proteasome
Sponsor Onyx Therapeutics, Inc.
Start date April 2009
End date December 2016
Trial size 100 participants
Trial identifier NCT00884312, PX-171-010

Summary

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.

United States No locations recruiting
Other Countries No locations recruiting

Study Design

Endpoint classification safety/efficacy study
Intervention model single group assignment
Masking open label
Primary purpose treatment
Arm
(Other)
To evaluate the safety and efficacy of long-term or continuing carfilzomib dosing in subjects who have completed a previous carfilzomib treatment.
carfilzomib PR-171
IV push on Days 1, 2, 15, and 16 of a 28 day cycle (e.g., every other week)

Primary Outcomes

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

Eligibility Criteria

Male or female participants at least 18 years old.

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.

Additional Information

Official title An Open-Label, Single-Arm, Phase 2 Study of Extended Carfilzomib Therapy in Subjects Previously Enrolled in Carfilzomib Treatment Protocols
Trial information was received from ClinicalTrials.gov and was last updated in October 2015.
Information provided to ClinicalTrials.gov by Onyx Pharmaceuticals.