Status:
COMPLETED
A Study to Evaluate the Effects of Rifampin on Pharmacokinetics (PK) of Pevonedistat in Participants With Advanced Solid Tumors
Lead Sponsor:
Millennium Pharmaceuticals, Inc.
Conditions:
Advanced Solid Neoplasm
Eligibility:
All Genders
18+ years
Phase:
PHASE1
Brief Summary
The purpose of this study is to assess the effect of multiple-dose administration of rifampin on the single dose PK of pevonedistat in adult participants with advanced solid tumors.
Detailed Description
The study will enroll approximately 20 participants. The study will be conducted in two Parts: Part A and optional Part B. Part A will have a drug-drug interaction (DDI) assessment. In Part A, partici...
Eligibility Criteria
Inclusion
- Adult participants who have a histologically or cytologically confirmed metastatic or locally advanced solid tumor that is appropriate for treatment with either docetaxel or carboplatin + paclitaxel in Part B of this study, or 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 of at least 3 months from the date of enrollment in the study.
- Recovered (that is, less than or equal to (\<=) Grade 1 toxicity) from the effects of prior antineoplastic therapy.
- Adequate organ functions (kidney, liver, cardiac, bone marrow).
- Suitable venous access for the study-required blood sampling (including PK sampling).
Exclusion
- Prior treatment with radiation therapy involving greater than or equal to (\>=) 25% of the hematopoietically active bone marrow.
- Life-threatening illness or serious (acute or chronic) medical or psychiatric illness unrelated to cancer.
- Active, uncontrolled infection or severe infectious disease.
- Known human immunodeficiency virus (HIV) seropositive or known hepatitis B or hepatitis C infection.
- With significant heart or pulmonary disease.
- Requiring chronic treatment with breast cancer resistance protein (BCRP) inhibitors.
- Criteria for Continuation into Optional Part B:
- To be eligible for Part B, participants must have completed Part A and be reassessed to determine if they meet the continuation criteria for Part B.
Key Trial Info
Start Date :
August 13 2018
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
February 28 2021
Estimated Enrollment :
20 Patients enrolled
Trial Details
Trial ID
NCT03486314
Start Date
August 13 2018
End Date
February 28 2021
Last Update
April 18 2022
Active Locations (4)
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1
Emory University
Atlanta, Georgia, United States, 30308
2
Robert H. Lurie Comprehensive Cancer Center of Northwestern University
Chicago, Illinois, United States, 60611
3
Barbara Ann Karmanos Cancer Institute
Detroit, Michigan, United States, 48201-2013
4
Greenville Health System - Institute for Translational Oncology Research
Greenville, South Carolina, United States, 29605