Phase 1
Completed N=44
A Study of Abemaciclib in Participants With Cancer That is Advanced or Has Spread to Another Part(s) of the Body
Neoplasm Metastasis
Source: ClinicalTrials.gov NCT02688088 ↗
Enrolled (actual)
44
Serious AEs
8.4%
Results posted
Oct 2022
Primary outcomePrimary: Pharmacokinetics: Maximum Concentration (Cmax) of Caffeine — 2890; 2950 nanograms per milliliter (ng/mL)
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 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.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Pharmacokinetics: Maximum Concentration (Cmax) of Caffeine |
2890; 2950 | — |
| PRIMARY Pharmacokinetics: Maximum Concentration (Cmax) S-Warfarin |
561; 526 | — |
| PRIMARY Pharmacokinetics: Maximum Concentration (Cmax) of Dextromethorphan |
3.18; 3.30 | — |
| PRIMARY Pharmacokinetics: Maximum Concentration (Cmax) of Midazolam |
2.12; 1.75 | — |
| PRIMARY Pharmacokinetics: Area Under the Concentration Versus Time Curve [AUC(0-infinity)] of Caffeine |
32500; 47100 | — |
| PRIMARY Pharmacokinetics: Area Under the Concentration Versus Time Curve [AUC(0-infinity)] of S-Warfarin |
21400; 20600 | — |
| PRIMARY Pharmacokinetics: Area Under the Concentration Versus Time Curve [AUC(0-infinity)] of Dextromethorphan |
32.6; 32.1 | — |
| PRIMARY Pharmacokinetics: Area Under the Concentration Versus Time Curve [AUC(0-infinity)] of Midazolam |
7.34; 6.03 | — |
| SECONDARY Mean Change From Baseline at 24 Hours in Systolic and Diastolic Blood Pressure in Period 1 |
-2.5; -0.7 | — |
| SECONDARY Mean Change From Baseline at 24 Hours in Pulse Rate in Period 1 |
-1.3 | — |
| SECONDARY Mean Change From Baseline at 24 Hours in Systolic and Diastolic Blood Pressure in Period 2 |
-11.6; -6.1 | — |
| SECONDARY Mean Change From Baseline at 24 Hours in Pulse Rate in Period 2 |
4.1 | — |
| SECONDARY Mean Change From Baseline at 24 Hours in Systolic and Diastolic Blood Pressure in Period 2 |
-11.6; -6.1 | — |
| SECONDARY Mean Change From Baseline at 24 Hours in Pulse Rate in Period 2 |
4.1 | — |
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
Data sourced from ClinicalTrials.gov (NCT02688088). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication. Informational only — not medical advice.