Phase 2
Completed N=101
A Study of Extended Carfilzomib Therapy for Patients Previously Enrolled in Carfilzomib Treatment Protocols
Source: ClinicalTrials.gov NCT00884312 ↗Enrolled (actual)
101
Serious AEs
62.0%
Results posted
May 2018
Primary outcomePrimary: Number of Participants With Peripheral Neuropathy — 1; 15 participants
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.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Number of Participants With Peripheral Neuropathy |
1; 15 | — |
| PRIMARY Number of Participants With Adverse Events |
7; 84; 5; 66; 5; 57 | — |
| SECONDARY Overall Survival |
1; 7 | — |
| SECONDARY Progression-free Survival |
41.9; 19.6 | — |
| SECONDARY Time to Progression |
NA; 19.6 | — |
Eligibility Criteria
Inclusion Criteria
- Previous completion of a carfilzomib study within 90 days prior to first dose of maintenance study drug.
- Disease Assessments performed within 30 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.
Data sourced from ClinicalTrials.gov (NCT00884312). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication. Informational only — not medical advice.