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

Lilly

Status and phase: Completed; Phase 1

Conditions: Neoplasm Metastasis

Treatments: Drug: Abemaciclib; Drug: Drug Cocktail

Study type: Interventional

Funder types: Industry

Identifiers

NCT02688088

15537

I3Y-MC-JPCB (Other Identifier)

Details and patient eligibility

About

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.

Enrollment: 48 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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 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

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

Trial design

Primary purpose: Basic Science

Allocation: Non-Randomized

Interventional model: Single Group Assignment

Masking: None (Open label)

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48 participants in 5 patient groups

Drug Cocktail - Period 1

Active Comparator group

Description:

Single dose of drug cocktail: 100 milligram (mg) caffeine,10 mg warfarin, 30 mg dextromethorphan, and 0.2 mg midazolam administered orally on Day 1 in Period 1.

Treatment:

Drug: Drug Cocktail

200 mg Abemaciclib + Drug Cocktail - Period 2

Experimental group

Description:

200 mg Abemaciclib administered orally every 12 hours (Q12H) on Days 1 - 12 in Period 2 with a single dose of drug cocktail: 100 mgcaffeine,10 mg warfarin, 30 mg dextromethorphan, and 0.2 mg midazolam administered orally on Day 8 in Period 2.

Treatment:

Drug: Drug Cocktail

Drug: Abemaciclib

200 mg Abemaciclib - Period 3

Experimental group

Description:

200 mg Abemaciclib administered orally Q12H on Days 13 to 28 in Period 3. Participants may continue to receive abemaciclib until discontinuation criteria are met.

Treatment:

Drug: Abemaciclib

200 mg Abemaciclib - Period 4

Experimental group

Description:

200 mg Abemaciclib administered orally Q12H on Days 1 to 28 in Period 4. Participants may continue to receive abemaciclib until discontinuation criteria are met.

Treatment:

Drug: Abemaciclib

Safety Extension Period

Experimental group

Description:

200 mg Abemaciclib administered orally Q12H on Days 1 to 28 onwards in extension period. Participants may continue to receive abemaciclib until discontinuation criteria are met.

Treatment:

Drug: Abemaciclib