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

Completed · Phase 1

Conditions studied: Neoplasm Metastasis

In brief

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 in a fixed sequence, with the option to continue to receive abemaciclib in a safety extension phase. All participants will complete a safety follow-up.

Key facts

Study ID

NCT02688088

Run by

Eli Lilly and Company

People needed

48

Starts

2016-03-08

Expected to finish

2021-01-06

Last updated by the study team

2022-10-18

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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 hormone therapy, 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

You may not qualify if…

• 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

Where it is running

• Sarah Cannon Research Institute at HealthOne — Denver, Colorado, United States
• IU Simon Cancer Center — Indianapolis, Indiana, United States
• University of Kansas Hospital — Fairway, Kansas, United States
• Mary Crowley Cancer Research Center — Dallas, Texas, United States
• South Texas Accelerated Research Therapeutics, LCC — San Antonio, Texas, United States

Full record on ClinicalTrials.gov

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