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

Metastatic Breast Cancer Clinical Trial

Official title:

An Open-Label, Randomized Phase 2 Study of the Impact of Food on Tolerability When Receiving Abemaciclib for Patients With Previously Treated Hormone Receptor-Positive, HER2-Negative, Metastatic Breast Cancer

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03703466
• Other study ID #: 17041
• Secondary ID: I3Y-MC-JPCP2018-
• Status: Completed
• Phase: Phase 2
• Start date: November 28, 2018
• Est. completion date: March 9, 2023

Study information

• Verified date: March 2024
• Source: Eli Lilly and Company
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 72
• Est. completion date: March 9, 2023
• Est. primary completion date: July 29, 2019
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Breast Neoplasms
• Metastatic Breast Cancer

Intervention

Drug:
• Abemaciclib
Administered orally.

Locations

Country	Name	City	State
Australia	Ashford Cancer Centre Research	Kurralta Park	South Australia
Australia	Peter MacCallum Cancer Centre	Melbourne	Victoria
Australia	Mater Private Hospital	North Sydney	New South Wales
Australia	St Vincent's Hospital	Sydney	New South Wales
Belgium	Universitaire Ziekenhuizen Leuven - Campus Gasthuisberg	Leuven
Russian Federation	Russian Oncological Research Center	Moscow
Russian Federation	Volgograd regional clinical oncology dispensary	Volgograd
Spain	Hospital Quirón Salud Barcelona-Instituto Oncológico Baselga	Barcelona
Spain	Hospital Universitari Vall d'Hebron	Barcelona
Spain	Hospital Clinico San Carlos	Madrid
Spain	Hospital Ruber Internacional	Madrid
Turkey	Akdeniz University Medical Faculty	Antalya
Turkey	Trakya University Faculty of Medicine	Edirne
Turkey	Medical Park Izmir Hospital	Izmir
Turkey	Inonu University Medical Faculty	Malatya

Sponsors (1)

Lead Sponsor	Collaborator
Eli Lilly and Company

Countries where clinical trial is conducted

Australia,  Belgium,  Russian Federation,  Spain,  Turkey, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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)
Primary	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)
Primary	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)
Primary	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)
Primary	Percentage of Participants Who Discontinue Treatment Due to Diarrhea	Percentage of participants who discontinue treatment due to diarrhea	Cycle 3 (28 Days Cycle)
Primary	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	Pharmacokinetics (PK): Mean Steady State Exposure of Abemaciclib	PK: Mean steady state exposure of abemaciclib	Cycle 1: Day 15; Cycle 2: Day 1, Day 15; Cycle 3: Day 1 (28 Days Cycle)
Secondary	PK: Mean Steady State Exposure of Abemaciclib Metabolite LSN2839567	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)
Secondary	PK: Mean Steady State Exposure of Abemaciclib Metabolite LSN3106726	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)

External Links

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