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

NCT03703466 | Completed Phase 2 Results FDA Drug

• 3 other identifiers: 17041I3Y-MC-JPCP2018-001853-28
• Study Type: interventional
• Target: 72
• Locations: 5 countries
• Sites: 15

Brief 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.

Conditions

Metastatic Breast Cancer

Outcome Measures

Primary Outcomes (6)

• Percentage of Participants With Severe Diarrhea (≥ Grade 3)

  Percentage of participants with severe diarrhea (≥ grade 3) during the first 3 cycles. Events were as assessed by the investigator and graded according to Common Terminology Criteria for Adverse Events (CTCAE). Grade 3 was defined as an increase of ≥7 stools per day over baseline; incontinence; hospitalization indicated; severe increase in ostomy output compared to baseline; limiting self-care activities of daily living (ADL).

  Cycle 3 (28 Days Cycle)

• Percentage of Participants With Prolonged Grade 2 Diarrhea

  Percentage of participants with prolonged grade 2 diarrhea during first 3 cycles. Events were as assessed by the investigator and graded according to Common Terminology Criteria for Adverse Events (CTCAE). Prolonged Grade 2 diarrhea was any event lasting more than 7 days. Grade 2 was defined as Increase of 4-6 stools per day over baseline; moderate increase in ostomy output compared to baseline.

  Cycle 3 (28 Days Cycle)

• Percentage of Participants With Dose Reductions Due to Diarrhea

  Percentage of participants with dose reductions due to diarrhea during first 3 cycles.

  Cycle 3 (28 Days Cycle)

• Percentage of Participants With Dose Interruptions Due to Diarrhea

  Percentage of participants with dose interruptions due to diarrhea during first 3 cycles.

  Cycle 3 (28 Days Cycle)

• Percentage of Participants Who Discontinue Treatment Due to Diarrhea

  Percentage of participants who discontinue treatment due to diarrhea

  Cycle 3 (28 Days Cycle)

• Percentage of Participants Utilizing Antidiarrheals

  Percentage of participants who utilized anti diarrheals at least once during the first 3 cycles.

  Cycle 3 (28 Days Cycle)

Secondary Outcomes (3)

• Pharmacokinetics (PK): Mean Steady State Exposure of Abemaciclib

  Cycle 1: Day 15; Cycle 2: Day 1, Day 15; Cycle 3: Day 1 (28 Days Cycle)

• PK: Mean Steady State Exposure of Abemaciclib Metabolite LSN2839567

  Cycle 1: Day 15; Cycle 2: Day1, Day 15; Cycle 3: Day 1 (28 Days Cycle)

• PK: Mean Steady State Exposure of Abemaciclib Metabolite LSN3106726

  Cycle 1: Day 15; Cycle 2: Day1, Day 15; Cycle 3: Day 1 (28 Days Cycle)

Study Arms (3)

200 mg Abemaciclib With a Meal

EXPERIMENTAL

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

Drug: Abemaciclib

200 mg Abemaciclib Without a Meal

EXPERIMENTAL

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

Drug: Abemaciclib

200 mg Abemaciclib Without Regard to Food

EXPERIMENTAL

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

Drug: Abemaciclib

Interventions

Abemaciclib DRUG

Administered orally.

Also known as: LY2835219

200 mg Abemaciclib With a Meal; 200 mg Abemaciclib Without Regard to Food; 200 mg Abemaciclib Without a Meal

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Eli Lilly and Company: lead

Study Sites (15)

Mater Private Hospital

North Sydney, New South Wales, 2291, Australia

Location

St Vincent's Hospital

Sydney, New South Wales, 2010, Australia

Location

Ashford Cancer Centre Research

Kurralta Park, South Australia, 5037, Australia

Location

Peter MacCallum Cancer Centre

Melbourne, Victoria, 3000, Australia

Location

Universitaire Ziekenhuizen Leuven - Campus Gasthuisberg

Leuven, 3000, Belgium

Location

Russian Oncological Research Center

Moscow, 115478, Russia

Location

Volgograd regional clinical oncology dispensary

Volgograd, 400138, Russia

Location

Hospital Quirón Salud Barcelona-Instituto Oncológico Baselga

Barcelona, 08023, Spain

Location

Hospital Universitari Vall d'Hebron

Barcelona, 08035, Spain

Location

Hospital Ruber Internacional

Madrid, 28034, Spain

Location

Hospital Clinico San Carlos

Madrid, 28040, Spain

Location

Akdeniz University Medical Faculty

Antalya, 07058, Turkey (Türkiye)

Location

Trakya University Faculty of Medicine

Edirne, 22030, Turkey (Türkiye)

Location

Medical Park Izmir Hospital

Izmir, 35575, Turkey (Türkiye)

Location

Inonu University Medical Faculty

Malatya, 44280, Turkey (Türkiye)

Location

Related Links

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

MeSH Terms

Conditions

Breast Neoplasms

Interventions

abemaciclib

Condition Hierarchy (Ancestors)

Neoplasms by Site; Neoplasms; Breast Diseases; Skin Diseases; Skin and Connective Tissue Diseases

Results Point of Contact

• Title: Chief Medical Officer
• Organization: Eli Lilly and Company

ClinicalTrials.gov@lilly.com

800-545-5979

Study Officials

• Call 1-877-CTLILLY (1-877-285-4559) or 1-317-615-4559 Mon - Fri 9 AM - 5 PM Eastern time (UTC/GMT - 5 hours, EST)

  Eli Lilly and Company

  STUDY DIRECTOR

Publication Agreements

• PI is Sponsor Employee: No
• Restriction Type: GT60
• Restrictive Agreement: Yes

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: October 5, 2018
• First Posted: October 12, 2018
• Study Start: November 28, 2018
• Primary Completion: July 29, 2019
• Study Completion: March 9, 2023
• Last Updated: April 2, 2024
• Results First Posted: August 13, 2020

Record last verified: 2024-03

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP, CSR
• Time Frame: Data are available 6 months after the primary publication and approval of the indication studied in the US and EU, whichever is later. Data will be indefinitely available for requesting.
• Access Criteria: A research proposal must be approved by an independent review panel and researchers must sign a data sharing agreement.

Locations

ES (4); RU (2); TU (4); AU (4); BE (1)