A Study of Extended Carfilzomib Therapy for Patients Previously Enrolled in Carfilzomib Treatment Protocols

• Status: Completed
• Trial end date: 2017-05-17
• Target enrollment: 0
• Participant gender: All

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 patients who previously completed a primary carfilzomib treatment study.

• Phase: Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Amgen; Onyx Therapeutics, Inc.

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 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.