A Study of Abemaciclib in Participants With Cancer That is Advanced or Has Spread to Another Part(s) of the Body

• Status: Completed
• Trial end date: 2021-01-06
• Target enrollment: 0
• Participant gender: All

Summary

This study is known as a "drug interaction study" and is being done to see how abemaciclib may affect the blood levels of a drug mixture of commonly used drugs (caffeine, warfarin, dextromethorphan, and midazolam) when taken in combination with abemaciclib. Each participant will complete screening and four study periods, with the option to continue to receive abemaciclib in a safety extension phase. All participants will complete a safety follow-up.

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

Details

• Lead Sponsor: Eli Lilly and Company
• Treatments: Caffeine; Dextromethorphan; Midazolam; Warfarin

Criteria

Inclusion Criteria:

• Have histological or cytological evidence of a diagnosis of cancer that is advanced and/or metastatic

• Have adequate organ function

• Have a performance status of ≤2 on the Eastern Cooperative Oncology Group (ECOG) scale

• Have discontinued all previous therapies for cancer (including chemotherapy, radiotherapy, immunotherapy, cancer-related hormonetherapy, and investigational therapy) for at least 21 days for myelosuppressive agents or 14 days for nonmyelosuppressive agents prior to receiving study drug and have recovered from the acute effects of therapy(treatment related toxicity resolved to baseline), except for residual alopecia

Exclusion Criteria:

• Require treatment with inducers or inhibitors of cytochrome P450 (CYP)1A2, CYP2C9, CYP2D6, and CYP3A within 14 days before the first dose of study drug through the end of Period 2

• History or presence of significant bleeding disorders

• Have known active uncontrolled or symptomatic CNS metastases

• Have a primary liver tumor

• Have lymphoma or leukemia