A Study to Evaluate the Effects of Pevonedistat on the Corrected QT (QTc) Interval in Participants With Advanced Solid Tumors

Completed · Phase 1

Conditions studied: Advanced Solid Neoplasm

In brief

The purpose of this study is to characterize the effects of 25 and 50 milligram per square meter (mg/m\^2) pevonedistat on the Fridericia corrected QT interval (QTcF) of the electrocardiogram (ECG).

Key facts

Study ID

NCT03330106

Run by

Millennium Pharmaceuticals, Inc.

People needed

68

Starts

2017-11-15

Expected to finish

2021-06-21

Last updated by the study team

2023-03-28

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• Participants must have a histologically or cytologically confirmed metastatic or locally advanced solid tumor(s) appropriate for treatment with one of the 2 combination therapies in Part B of this study, have progressed despite standard therapy, or for whom conventional therapy is not considered effective.
• Eastern Cooperative Oncology Group (ECOG) performance status of 0 to 1.
• Expected survival longer than 3 months from enrollment in the study.
• Recovered (that is, grade less than or equal to [<=] 1 toxicity) from the reversible effects of prior anticancer therapy.
• Suitable venous access for the study-required blood sampling (including pharmacokinetic [PK] sampling).

You may not qualify if…

• Treatment with strong cytochrome P3A (CYP3A) inducers within 14 days before the first dose of pevonedistat. Participants must have no history of amiodarone use within 6 months before the first dose of pevonedistat nor require the use of these medications during the study.
• Treatment with QT-prolonging drugs with a risk of causing torsades de pointes (TdP. Participants taking drugs with a possible or conditional risk of QT prolongation or drugs that are to be avoided by participants with congenital long QT syndrome may be considered if on a stable dose, pending discussion and agreement between the investigator and the sponsor.
• History of Brugada syndrome, risk factors for TdP, or family history of long QT syndrome.
• Implantable cardioverter defibrillator.
• Cardiac pacemaker with heart rate (HR) set at a fixed rate and treatment with concomitant medication that may limit increase in HR in response to hypotension (example, high-dose beta blocker).
• Known moderate to severe aortic stenosis, moderate to severe mitral stenosis, or other valvulopathy (ongoing).
• Admission or evidence of illicit drug use, drug abuse, or alcohol abuse.
• Entry Criteria for Continuation to Optional Part B:
• After completing Part A of the study, participants may choose to enter the optional Part B of the study. To be eligible for the optional Part B, participants must have completed Part A and be reassessed to determine if they meet the entry criteria for optional Part B. Only participants who meet the following criteria may enter into Part B:
• ECOG performance status of 0 to 1.
• Absolute neutrophil count (ANC) greater than or equal to (>=) 1500 per cubic millimeter (/mm\^3).
• Platelet count >=100,000/mm\^3.
• Laboratory values for hemoglobin, total bilirubin, alanine aminotransferase (ALT), aspartate aminotransferase (AST), alkaline phosphatase (ALP), and serum creatinine or calculated/measured creatinine clearance.
• Diarrhea symptoms resolved to Grade 1 or better.
• QTc interval <480 millisecond (msec).
• Computed tomography (CT) scan or magnetic resonance imaging (MRI) of the chest, abdomen, and pelvis within 28 days of Cycle 1 Day 1.

Where it is running

• Sarcoma Oncology Center — Santa Monica, California, United States
• Moffitt Cancer Center — Tampa, Florida, United States
• Henry Ford Hospital — Detroit, Michigan, United States
• Montefiore Medical Center — The Bronx, New York, United States
• Case Western Reserve University — Cleveland, Ohio, United States
• University of Oklahoma Health Sciences Center — Oklahoma City, Oklahoma, United States
• Mary Crowley Medical Research — Dallas, Texas, United States
• Virginia Cancer Specialists — Fairfax, Virginia, United States

Full record on ClinicalTrials.gov

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