A Study to Evaluate the Effects of Rifampin on Pharmacokinetics (PK) of Pevonedistat in Participants With Advanced Solid Tumors

• Status: Completed
• Trial end date: 2021-02-28
• Target enrollment: 0
• Participant gender: All

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.

• Phase: Phase 1
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Millennium Pharmaceuticals, Inc.
• Treatments: Albumin-Bound Paclitaxel; Carboplatin; Docetaxel; Paclitaxel; Pevonedistat; Rifampin

Criteria

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.