Phase 2
Completed N=72
A Study of Abemaciclib (LY2835219) With and Without Food in Participants With Metastatic Breast Cancer
Source: ClinicalTrials.gov NCT03703466 ↗Enrolled (actual)
72
Serious AEs
22.5%
Results posted
Aug 2020
Primary outcomePrimary: Percentage of Participants With Severe Diarrhea (≥ Grade 3) — 4.2; 0; 0 percentage of participants
Summary
The main purpose of this study is to examine the side effects that participants with metastatic breast cancer experience when taking abemaciclib with or without food.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Percentage of Participants With Severe Diarrhea (≥ Grade 3) |
4.2; 0; 0 | — |
| PRIMARY Percentage of Participants With Prolonged Grade 2 Diarrhea |
8.3; 17.4; 20.8 | — |
| PRIMARY Percentage of Participants With Dose Reductions Due to Diarrhea |
16.7; 8.7; 12.5 | — |
| PRIMARY Percentage of Participants With Dose Interruptions Due to Diarrhea |
16.7; 4.3; 8.3 | — |
| PRIMARY Percentage of Participants Who Discontinue Treatment Due to Diarrhea |
0; 0; 0 | — |
| PRIMARY Percentage of Participants Utilizing Antidiarrheals |
95.8; 91.3; 95.8 | — |
| SECONDARY Pharmacokinetics (PK): Mean Steady State Exposure of Abemaciclib |
305; 369; 356; 320; 280; 190 | — |
| SECONDARY PK: Mean Steady State Exposure of Abemaciclib Metabolite LSN2839567 |
139; 129; 159; 125; 109; 96.3 | — |
| SECONDARY PK: Mean Steady State Exposure of Abemaciclib Metabolite LSN3106726 |
231; 242; 287; 230; 210; 152 | — |
Eligibility Criteria
Inclusion Criteria
- Have a diagnosis of HR+, HER2- metastatic breast cancer (mBC).
- Have all of the following:
- Recurrent, locally advanced, unresectable or mBC with disease progression following anti-estrogen therapy.
- Prior treatment with chemotherapy for locally advanced or metastatic disease.
- No prior treatment with cyclin-dependent kinases (CDK) 4 and 6 inhibitor.
- Have Eastern Cooperative Oncology Group performance status (ECOG PS) ≤1.
- Have discontinued all previous treatments for cancer and recovered from the acute effects of therapy.
- Have adequate organ function.
- Women of child-bearing potential must have a negative pregnancy test.
- Are able to swallow tablets/capsules.
Exclusion Criteria
- Are currently receiving treatment in a clinical study involving an investigational product.
- Have a serious concomitant systemic disorder.
- Have symptomatic central nervous system (CNS) malignancy or metastasis.
- Have a symptomatic Human Immunodeficiency Virus (HIV) infection or symptomatic activated/reactivated hepatitis A, B, or C.
- Have a personal history of syncope of either unexplained or cardiovascular etiology, ventricular tachycardia, ventricular fibrillation, or sudden cardiac arrest.
- Have a history of any other cancer.
- Had major surgery within 14 days prior to randomization.
- Are breastfeeding.
- Have received treatment with a drug that has not received regulatory approval for any indication within 14 or 21 days of the initial dose of study drug for a nonmyelosuppressive or myelosuppressive agent, respectively.
Data sourced from ClinicalTrials.gov (NCT03703466). 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.