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Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/study/NCT03703466




Registration number
NCT03703466
Ethics application status
Date submitted
5/10/2018
Date registered
12/10/2018

Titles & IDs
Public title
A Study of Abemaciclib (LY2835219) With and Without Food in Participants With Metastatic Breast Cancer
Scientific 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
Secondary ID [1] 0 0
I3Y-MC-JPCP
Secondary ID [2] 0 0
17041
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Metastatic Breast Cancer 0 0
Condition category
Condition code
Cancer 0 0 0 0
Breast

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Treatment: Drugs - Abemaciclib

Experimental: 200 mg Abemaciclib With a Meal - 200 mg abemaciclib given twice a day (BID) orally with a meal.

Experimental: 200 mg Abemaciclib Without a Meal - 200 mg abemaciclib given twice a day (BID) orally without a meal, taken in the modified fasted condition.

Experimental: 200 mg Abemaciclib Without Regard to Food - 200 mg abemaciclib given twice a day (BID) orally without regard for food.


Treatment: Drugs: Abemaciclib
Administered orally.
Intervention code [1] 0 0
Treatment: Drugs
Comparator / control treatment
Control group

Outcomes
Primary outcome [1] 0 0
Percentage of Participants With Severe Diarrhea (= Grade 3)
Timepoint [1] 0 0
Cycle 3 (28 Days Cycle)
Primary outcome [2] 0 0
Percentage of Participants With Prolonged Grade 2 Diarrhea
Timepoint [2] 0 0
Cycle 3 (28 Days Cycle)
Primary outcome [3] 0 0
Percentage of Participants With Dose Reductions Due to Diarrhea
Timepoint [3] 0 0
Cycle 3 (28 Days Cycle)
Primary outcome [4] 0 0
Percentage of Participants With Dose Interruptions Due to Diarrhea
Timepoint [4] 0 0
Cycle 3 (28 Days Cycle)
Primary outcome [5] 0 0
Percentage of Participants Who Discontinue Treatment Due to Diarrhea
Timepoint [5] 0 0
Cycle 3 (28 Days Cycle)
Primary outcome [6] 0 0
Percentage of Participants Utilizing Antidiarrheals
Timepoint [6] 0 0
Cycle 3 (28 Days Cycle)
Secondary outcome [1] 0 0
Pharmacokinetics (PK): Mean Steady State Exposure of Abemaciclib
Timepoint [1] 0 0
Cycle 1: Day 15; Cycle 2: Day 1, Day 15; Cycle 3: Day 1 (28 Days Cycle)
Secondary outcome [2] 0 0
PK: Mean Steady State Exposure of Abemaciclib Metabolite LSN2839567
Timepoint [2] 0 0
Cycle 1: Day 15; Cycle 2: Day1, Day 15; Cycle 3: Day 1 (28 Days Cycle)
Secondary outcome [3] 0 0
PK: Mean Steady State Exposure of Abemaciclib Metabolite LSN3106726
Timepoint [3] 0 0
Cycle 1: Day 15; Cycle 2: Day1, Day 15; Cycle 3: Day 1 (28 Days Cycle)

Eligibility
Key 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.
Minimum age
18 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
No
Key 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.

Study design
Purpose of the study
Treatment
Allocation to intervention
Randomised controlled trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Masking / blinding
Open (masking not used)
Who is / are masked / blinded?



Intervention assignment
Parallel
Other design features
Phase
Phase 2
Type of endpoint/s
Statistical methods / analysis

Recruitment
Recruitment status
Completed
Data analysis
Reason for early stopping/withdrawal
Other reasons
Date of first participant enrolment
Anticipated
Actual
28/11/2018
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
9/03/2023
Sample size
Target
Accrual to date
Final
72
Recruitment in Australia
Recruitment state(s)
NSW,SA,VIC
Recruitment hospital [1] 0 0
Mater Private Hospital - North Sydney
Recruitment hospital [2] 0 0
St Vincent's Hospital - Sydney
Recruitment hospital [3] 0 0
Ashford Cancer Centre Research - Kurralta Park
Recruitment hospital [4] 0 0
Peter MacCallum Cancer Centre - Melbourne
Recruitment postcode(s) [1] 0 0
2291 - North Sydney
Recruitment postcode(s) [2] 0 0
2010 - Sydney
Recruitment postcode(s) [3] 0 0
5037 - Kurralta Park
Recruitment postcode(s) [4] 0 0
3000 - Melbourne
Recruitment outside Australia
Country [1] 0 0
Belgium
State/province [1] 0 0
Leuven
Country [2] 0 0
Russian Federation
State/province [2] 0 0
Moscow
Country [3] 0 0
Russian Federation
State/province [3] 0 0
Volgograd
Country [4] 0 0
Spain
State/province [4] 0 0
Barcelona
Country [5] 0 0
Spain
State/province [5] 0 0
Madrid
Country [6] 0 0
Turkey
State/province [6] 0 0
Antalya
Country [7] 0 0
Turkey
State/province [7] 0 0
Edirne
Country [8] 0 0
Turkey
State/province [8] 0 0
Izmir
Country [9] 0 0
Turkey
State/province [9] 0 0
Malatya

Funding & Sponsors
Primary sponsor type
Commercial sector/industry
Name
Eli Lilly and Company
Address
Country

Ethics approval
Ethics application status

Summary
Brief summary
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 0 0
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)
Address 0 0
Eli Lilly and Company
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for public queries
Name 0 0
Address 0 0
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for scientific queries

Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
Yes
What data in particular will be shared?
Anonymized individual patient level data will be provided in a secure access environment upon approval of a research proposal and a signed data sharing agreement.

Supporting document/s available: Study protocol, Statistical analysis plan (SAP), Clinical study report (CSR)
When will data be available (start and end dates)?
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.
Available to whom?
A research proposal must be approved by an independent review panel and researchers must sign a data sharing agreement.
Available for what types of analyses?
How or where can data be obtained?
IPD available at link: https://vivli.org/


What supporting documents are/will be available?




Results publications and other study-related documents

No documents have been uploaded by study researchers.


Results are available at https://clinicaltrials.gov/study/NCT03703466