A Study of Abemaciclib (LY2835219) With and Without Food in Participants With Metastatic Breast Cancer

Lilly

Status and phase: Completed; Phase 2

Conditions: Metastatic Breast Cancer

Treatments: Drug: Abemaciclib

Study type: Interventional

Funder types: Industry

Identifiers

NCT03703466

17041

I3Y-MC-JPCP (Other Identifier)

2018-001853-28 (EudraCT Number)

Details and patient eligibility

About

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.

Enrollment: 72 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

---

72 participants in 3 patient groups

200 mg Abemaciclib With a Meal

Experimental group

Description:

200 mg abemaciclib given twice a day (BID) orally with a meal.

Treatment:

Drug: Abemaciclib

200 mg Abemaciclib Without a Meal

Experimental group

Description:

200 mg abemaciclib given twice a day (BID) orally without a meal, taken in the modified fasted condition.

Treatment:

Drug: Abemaciclib

200 mg Abemaciclib Without Regard to Food

Experimental group

Description:

200 mg abemaciclib given twice a day (BID) orally without regard for food.

Treatment:

Drug: Abemaciclib