Overview

This trial is active, not recruiting.

Conditions relapsed multiple myeloma, end-stage renal disease
Treatment carfilzomib
Phase phase 1
Target proteasome
Sponsor Onyx Therapeutics, Inc.
Start date October 2013
End date April 2015
Trial size 32 participants
Trial identifier NCT01949532, CFZ001

Summary

The purpose of this study is to see how the body and the cancer react to an investigational drug called carfilzomib, including measuring the amount of the study drug in the blood at certain times following dosing. This study is being done in people with normal kidney function and those with end-stage renal disease to see if they respond differently to the study drug.

United States No locations recruiting
Other Countries No locations recruiting

Study Design

Allocation non-randomized
Endpoint classification pharmacokinetics study
Intervention model parallel assignment
Masking open label
Arm
(Experimental)
Subjects with CrCl ≥ 90 mL/min
carfilzomib Kyprolis® (carfilzomib) for Injection
For Cycle 1, subjects will receive carfilzomib 20 mg/m2 IV on Days 1 and 2, followed by escalation to 27 mg/m2 on Days 8, 9, 15, and 16 of a 28-day cycle. For Cycles 2 and higher, subjects will receive carfilzomib 56 mg/m2 on Days 1, 2, 8, 9, 15, and 16, as tolerated.
(Experimental)
Subjects on hemodialysis
carfilzomib Kyprolis® (carfilzomib) for Injection
For Cycle 1, subjects will receive carfilzomib 20 mg/m2 IV on Days 1 and 2, followed by escalation to 27 mg/m2 on Days 8, 9, 15, and 16 of a 28-day cycle. For Cycles 2 and higher, subjects will receive carfilzomib 56 mg/m2 on Days 1, 2, 8, 9, 15, and 16, as tolerated.

Primary Outcomes

Measure
Influence of End-stage Renal Disease on Area Under the Curve
time frame: Cycle 2 Day 1

Secondary Outcomes

Measure
Influence of End-stage Renal Disease on Additional Pharmacokinetics (PK) Parameters of Carfilzomib 56 mg/m2 at Cycle 2 Day 1 (C2D1)
time frame: Cycle 2 Day 1
Influence of End-stage Renal Disease on Additional Pharmacokinetics (PK) Parameters of Carfilzomib 27 mg/m2
time frame: Cycle 1 Day 16
Influence of End-stage Renal Disease on Additional Pharmacokinetics (PK) parameters for major metabolites
time frame: Cycle 1 Day 16 and Cycle 2 Day 1
Safety and Tolerability
time frame: 24 months

Eligibility Criteria

Male or female participants at least 18 years old.

Key Inclusion Criteria: 1. Relapsed multiple myeloma 2. Evaluable disease (SPEP/UPEP/SFLC) 3. ≥1 and ≤3 prior lines of treatment 4. ESRD on hemodialysis or CrCl≥90 mL/min 5. ECOG 0-2 6. Adequate organ and bone marrow function 7. Active congestive heart failure (New York Heart Association [NYHA] Class III to IV), symptomatic ischemia, conduction abnormalities uncontrolled by conventional intervention or myocardial infarction within the protocol-specified period prior to enrollment Key Exclusion Criteria: 1. Immunogluobulin M (IgM) multiple myeloma 2. POEMS syndrome (polyneuropathy, organomegaly, endocrinopathy, monoclonal protein, and skin changes) 3. Waldenström Macroglobulinemia 4. Active CHF (NYHA Class III-IV) ischemia, conduction abnormalities 5. Known HIV, recent HBV, HCV 6. Myelodysplastic Syndrome 7. Contraindication to test article, constituents, or required concomitant medications 8. Other investigational drugs

Additional Information

Official title An Open-Label, Single Arm, Phase 1 Study of the Pharmacokinetics and Safety of Carfilzomib in Subjects With Relapsed Multiple Myeloma and End-stage Renal Disease
Description Specifically, the purpose of this study is to assess the influence of End-stage Renal Disease (ESRD) on area under the curve (both area under the curve, from time 0 to the last concentration measured [AUC0-last] and area under the curve, from time 0 extrapolated to infinity [AUC0-inf]) of carfilzomib 56 mg/m2 at Cycle 2 Day 1 (C2D1) in subjects with relapsed multiple myeloma
Trial information was received from ClinicalTrials.gov and was last updated in October 2015.
Information provided to ClinicalTrials.gov by Onyx Pharmaceuticals.
Location data was received from the National Cancer Institute and was last updated in May 2016.