Clinical trial · Interventional
A Study to Evaluate the Effects of Rifampin on Pharmacokinetics (PK) of Pevonedistat in Participants With Advanced Solid Tumors
A Phase 1 Study to Evaluate the Effects of Rifampin on Pharmacokinetics of Pevonedistat in Patients With Advanced Solid Tumors
NCT03486314CI-TRIAL-00057870completedPhase 1Results postedClinicalTrials.gov clinicaltrialsProvenance
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
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.
Conditions
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Advanced Solid Neoplasm | Solid Neoplasm | CURATED_BROADER | 0.78 |
Interventions
Interventions (5)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Carboplatin | Drug | Carboplatin | ALIAS |
| Docetaxel | Drug | Docetaxel | ALIAS |
| Paclitaxel | Drug | Paclitaxel | ALIAS |
| Pevonedistat | Drug | — | UNRESOLVED |
| Rifampin | Drug | — | UNRESOLVED |
Design
Arms and outcomes
Arms (2)
- type
- EXPERIMENTAL
- label
- Part A: Pevonedistat 50 mg/m^2 + Rifampin 600 mg
- description
- Pevonedistat 50 milligram per square meter (mg/m\^2), intravenous infusion, once on Day 1 and 10 along with rifampin 600 milligram (mg), capsule, orally, once daily from Day 3 up to Day 11 in Part A. After completion of Part A, participants had opportunity to continue into optional Part B.
- interventionNames
- Drug: Pevonedistat
- Drug: Rifampin
- type
- EXPERIMENTAL
- label
- Part B: Pevonedistat
- description
- Pevonedistat 25 mg/m\^2 intravenously in combination with docetaxel 75 mg/m\^2 or at 20 mg/m\^2 in combination with carboplatin +paclitaxel 175 mg/m\^2; pevonedistat was given in combination on Day 1 and as a single agent on Days 3 and 5 of each 21-day cycle. Participants were treated for up to 12 cycles or symptomatic deterioration or PD, treatment was discontinued for another reason, or until the study is stopped in Part B. The choice of combination partner (docetaxel or carboplatin + paclitaxel) was based on investigator discretion. If the sponsor and investigator determine that a participant would derive clinical benefit from continued treatment, the participant may remain on the current combination therapy or receive pevonedistat as a single agent beyond 12 cycles.
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
Inclusion Criteria: 1. 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. 2. Eastern Cooperative Oncology Group (ECOG) performance status of 0 to 1. 3. Expected survival of at least 3 months from the date of enrollment in the study. 4. Recovered (that is, less than or equal to (\<=) Grade 1 toxicity) from the effects of prior antineoplastic therapy. 5. Adequate organ functions (kidney, liver, cardiac, bone marrow). 6. Suitable venous access for the study-required blood sampling (including PK sampling). Exclusion Criteria: 1. Prior treatment with radiation therapy involving greater than or equal to (\>=) 25% of the hematopoietically active bone marrow. 2. Life-threatening illness or serious (acute or chronic) medical or psychiatric illness unrelated to cancer. 3. Active, uncontrolled infection or severe infectious disease. 4. Known human immunodeficiency virus (HIV) seropositive or known hepatitis B or hepatitis C infection. 5. With significant heart or pulmonary disease. 6. 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.
References
Publications (1)
- DERIVEDZhou X, Vaishampayan U, Mahalingam D, Harvey RD, Chung KY, Sedarati F, Dong C, Faller DV, Venkatakrishnan K, Gupta N. Phase 1 study to evaluate the effects of rifampin on pharmacokinetics of pevonedistat, a NEDD8-activating enzyme inhibitor in patients with advanced solid tumors. Invest New Drugs. 2022 Oct;40(5):1042-1050. doi: 10.1007/s10637-022-01286-8. Epub 2022 Aug 6. PMID 35932388