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.
Study sponsor and potential other locations can be found on ClinicalTrials.gov for NCT03486314.
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, participants will be assigned to:
• Pevonedistat 50 mg/m^2 + Rifampin
Eligible participants from Part A will continue treatment in optional Part B with
pevonedistat in combination with SoC chemotherapy, docetaxel or carboplatin plus
paclitaxel. The investigator will decide which SoC combination partner a participant will
receive.
- Pevonedistat 25 mg/m^2 + Docetaxel
- Pevonedistat 20 mg/m^2 + Carboplatin + Paclitaxel
This multi-center trial will be conducted in the United States. The overall time to
participate in this study is 18 months. Participants will make a final visit to the
clinic 30 days after receiving their last dose of study drug or before the start of
subsequent therapy.
Trial PhasePhase I
Trial TypeNot provided by clinicaltrials.gov
Lead OrganizationMillennium Pharmaceuticals, Inc.
