Clinical trial NCT03703466: A Study of Abemaciclib (LY2835219) With and Without Food in Participants With Metastatic Breast Cancer
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
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Metastatic Breast Cancer
Lead sponsor: Eli Lilly and Company
Sponsor class: INDUSTRY
First posted: 2018-10-12
Enrollment: 72
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.


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.

Primary outcomes:
measure: Percentage of Participants With Severe Diarrhea (≥ Grade 3)
timeFrame: Cycle 3 (28 Days Cycle)
measure: Percentage of Participants With Prolonged Grade 2 Diarrhea
timeFrame: Cycle 3 (28 Days Cycle)
measure: Percentage of Participants With Dose Reductions Due to Diarrhea
timeFrame: Cycle 3 (28 Days Cycle)
measure: Percentage of Participants With Dose Interruptions Due to Diarrhea
timeFrame: Cycle 3 (28 Days Cycle)
measure: Percentage of Participants Who Discontinue Treatment Due to Diarrhea
timeFrame: Cycle 3 (28 Days Cycle)
measure: Percentage of Participants Utilizing Antidiarrheals
timeFrame: Cycle 3 (28 Days Cycle)
Secondary outcomes:
measure: Pharmacokinetics (PK): Mean Steady State Exposure of Abemaciclib
timeFrame: Cycle 1: Day 15; Cycle 2: Day 1, Day 15; Cycle 3: Day 1 (28 Days Cycle)
measure: PK: Mean Steady State Exposure of Abemaciclib Metabolite LSN2839567
timeFrame: Cycle 1: Day 15; Cycle 2: Day1, Day 15; Cycle 3: Day 1 (28 Days Cycle)
measure: PK: Mean Steady State Exposure of Abemaciclib Metabolite LSN3106726
timeFrame: Cycle 1: Day 15; Cycle 2: Day1, Day 15; Cycle 3: Day 1 (28 Days Cycle)
Other outcomes:
Locations:
city: North Sydney
country: Australia
facility: Mater Private Hospital
state: New South Wales
city: Sydney
country: Australia
facility: St Vincent's Hospital
state: New South Wales
city: Kurralta Park
country: Australia
facility: Ashford Cancer Centre Research
state: South Australia
city: Melbourne
country: Australia
facility: Peter MacCallum Cancer Centre
state: Victoria
city: Leuven
country: Belgium
facility: Universitaire Ziekenhuizen Leuven - Campus Gasthuisberg
city: Moscow
country: Russian Federation
facility: Russian Oncological Research Center
city: Volgograd
country: Russian Federation
facility: Volgograd regional clinical oncology dispensary
city: Barcelona
country: Spain
facility: Hospital Quirón Salud Barcelona-Instituto Oncológico Baselga
city: Barcelona
country: Spain
facility: Hospital Universitari Vall d'Hebron
city: Madrid
country: Spain
facility: Hospital Ruber Internacional
city: Madrid
country: Spain
facility: Hospital Clinico San Carlos
city: Antalya
country: Turkey
facility: Akdeniz University Medical Faculty
city: Edirne
country: Turkey
facility: Trakya University Faculty of Medicine
city: Izmir
country: Turkey
facility: Medical Park Izmir Hospital
city: Malatya
country: Turkey
facility: Inonu University Medical Faculty
Study officials:
affiliation: Eli Lilly and Company
name: 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)
role: STUDY_DIRECTOR
References: