A Study to Evaluate the Effects of Pevonedistat on the Corrected QT (QTc) Interval in Participants With Advanced Solid Tumors
NCT03330106 · Status: COMPLETED · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 68
Last updated 2023-03-28
Summary
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).
Conditions
- Advanced Solid Neoplasm
Interventions
- DRUG
-
Pevonedistat
Pevonedistat intravenous infusion.
- DRUG
-
Docetaxel intravenous infusion.
- DRUG
-
Carboplatin intravenous infusion.
- DRUG
-
Paclitaxel intravenous infusion.
Sponsors & Collaborators
-
Millennium Pharmaceuticals, Inc.
lead INDUSTRY
Principal Investigators
-
Medical Director · Millennium Pharmaceuticals, Inc.
Study Design
- Allocation
- RANDOMIZED
- Purpose
- OTHER
- Masking
- NONE
- Model
- CROSSOVER
Eligibility
- Min Age
- 18 Years
- Sex
- ALL
- Healthy Volunteers
- No
Timeline & Regulatory
- Start
- 2017-11-15
- Primary Completion
- 2019-01-07
- Completion
- 2021-06-21
- FDA Drug
- Yes
Countries
- United States
Study Locations
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