A Study of Abemaciclib in Participants With Cancer That is Advanced or Has Spread to Another Part(s) of the Body
Neoplasm Metastasis
About this trial
This is an interventional basic science trial for Neoplasm Metastasis
Eligibility 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 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
Sites / Locations
- Sarah Cannon Research Institute at HealthOne
- IU Simon Cancer Center
- University of Kansas Hospital
- Mary Crowley Cancer Research Center
- South Texas Accelerated Research Therapeutics, LCC
Arms of the Study
Arm 1
Arm 2
Arm 3
Arm 4
Arm 5
Active Comparator
Experimental
Experimental
Experimental
Experimental
Drug Cocktail - Period 1
200 mg Abemaciclib + Drug Cocktail - Period 2
200 mg Abemaciclib - Period 3
200 mg Abemaciclib - Period 4
Safety Extension Period
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.
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.
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.
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.
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.