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Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/show/NCT04188548




Registration number
NCT04188548
Ethics application status
Date submitted
18/11/2019
Date registered
6/12/2019
Date last updated
11/06/2020

Titles & IDs
Public title
A Study of LY3484356 in Participants With Advanced or Metastatic Breast Cancer or Endometrial Cancer
Scientific title
A Phase 1a/1b Study of LY3484356 Administered as Monotherapy and in Combination With Abemaciclib to Patients With ER+, HER2- Locally Advanced or Metastatic Breast Cancer and Other Select Non-Breast Cancers
Secondary ID [1] 0 0
J2J-MC-JZLA
Secondary ID [2] 0 0
17502
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Breast Cancer 0 0
Advanced Breast Cancer 0 0
Metastatic Breast Cancer 0 0
Endometrial Cancer 0 0
Condition category
Condition code
Cancer 0 0 0 0
Breast
Cancer 0 0 0 0
Womb (Uterine or endometrial cancer)

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Treatment: Drugs - LY3484356
Treatment: Drugs - Abemaciclib

Experimental: Dose Escalation LY3484356 - LY3484356 given orally.

Experimental: Dose Escalation LY3484356 + Abemaciclib - LY3484356 and abemaciclib given orally.

Experimental: Dose Expansion LY3484356 - LY3484356 given orally.

Experimental: Dose Expansion LY3484356 + Abemaciclib - LY3484356 and abemaciclib given orally.


Treatment: Drugs: LY3484356
Administered orally

Treatment: Drugs: Abemaciclib
Administered orally

Intervention code [1] 0 0
Treatment: Drugs
Comparator / control treatment
Control group

Outcomes
Primary outcome [1] 0 0
Number of Participants with Dose Limiting Toxicities (DLTs) - Number of Participants with DLTs
Timepoint [1] 0 0
Baseline through Cycle 1 (28 Day Cycle)
Secondary outcome [1] 0 0
Pharmacokinetics (PK): Area Under the Concentration Time Curve (AUC) of LY3484356 - PK: AUC of LY3484356
Timepoint [1] 0 0
Predose Cycle 1 Day 1 through Predose Cycle 2 Day 1 (28 Day Cycles)
Secondary outcome [2] 0 0
PK: Maximum Concentration (Cmax) of LY3484356 - PK: Cmax of LY3484356
Timepoint [2] 0 0
Predose Cycle 1 Day 1 through Predose Cycle 2 Day 1 (28 Day Cycles)
Secondary outcome [3] 0 0
PK: AUC of LY3484356 in Combination with Abemaciclib - PK: AUC of LY3484356 in Combination with Abemaciclib
Timepoint [3] 0 0
Predose Cycle 1 Day 1 through Predose Cycle 2 Day 1 (28 Day Cycles)
Secondary outcome [4] 0 0
PK: Cmax of LY3484356 in Combination with Abemaciclib - PK: Cmax of LY3484356 in Combination with Abemaciclib
Timepoint [4] 0 0
Predose Cycle 1 Day 1 through Predose Cycle 2 Day 1 (28 Day Cycles)
Secondary outcome [5] 0 0
Overall Response Rate (ORR): Percentage of Participants with Complete Response (CR) or Partial Response (PR) - ORR: Percentage of Participants with CR or PR
Timepoint [5] 0 0
Baseline through Disease Progression or Death (Estimated up to 42 Months)
Secondary outcome [6] 0 0
Duration of Response (DoR) - DoR
Timepoint [6] 0 0
Date of CR or PR to Date of Objective Disease Progression or Death Due to Any Cause (Estimated up to 42 Months)
Secondary outcome [7] 0 0
Disease Control Rate (DCR): Percentage of Participants with a Best Overall Response of CR, PR, and Stable Disease - DCR: Percentage of Participants with a Best Overall Response of CR, PR, and Stable Disease
Timepoint [7] 0 0
Baseline through Measured Progressive Disease (Estimated up to 42 Months)
Secondary outcome [8] 0 0
Progression Free Survival (PFS) - PFS
Timepoint [8] 0 0
Baseline to Objective Progression or Death Due to Any Cause (Estimated up to 42 Months)

Eligibility
Key inclusion criteria
- Participants must have one of the following:

- Estrogen receptor positive (ER+), human epidermal growth factor receptor 2
negative (HER2-) breast cancer that may have spread to other part(s) of the body
and has had up to 3 lines of standard therapy and progression while on
endocrine-containing therapy for =24 months in the adjuvant setting or =6 months
in advanced/metastatic setting

- Endometrioid endometrial cancer (EEC) having progressed on standard of care and
must have had prior platinum-containing therapy

- Participants must be willing to provide adequate archival tissue sample

- Participants must be willing to use highly effective birth control

- Participants must have adequate organ function

- Participants must be able to swallow capsules
Minimum age
18 Years
Maximum age
No limit
Gender
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
- Participants must not have certain infections such as hepatitis or tuberculosis or HIV
that are not well controlled

- Participants must not have another serious medical condition

- Participants must not have cancer of the central nervous system that is not stable

- Participants must not be pregnant or breastfeeding

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 1
Type of endpoint(s)
Statistical methods / analysis

Recruitment
Recruitment status
Recruiting
Data analysis
Reason for early stopping/withdrawal
Other reasons
Date of first participant enrolment
Anticipated
Actual
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
NSW,WA
Recruitment hospital [1] 0 0
St Vincent's Hospital - Darlinghurst
Recruitment hospital [2] 0 0
Linear Clinical Research Ltd - Nedlands
Recruitment postcode(s) [1] 0 0
2010 - Darlinghurst
Recruitment postcode(s) [2] 0 0
6009 - Nedlands
Recruitment outside Australia
Country [1] 0 0
United States of America
State/province [1] 0 0
Arkansas
Country [2] 0 0
United States of America
State/province [2] 0 0
California
Country [3] 0 0
United States of America
State/province [3] 0 0
Florida
Country [4] 0 0
United States of America
State/province [4] 0 0
Georgia
Country [5] 0 0
United States of America
State/province [5] 0 0
Maryland
Country [6] 0 0
United States of America
State/province [6] 0 0
Massachusetts
Country [7] 0 0
United States of America
State/province [7] 0 0
Minnesota
Country [8] 0 0
United States of America
State/province [8] 0 0
New York
Country [9] 0 0
United States of America
State/province [9] 0 0
North Carolina
Country [10] 0 0
United States of America
State/province [10] 0 0
Ohio
Country [11] 0 0
United States of America
State/province [11] 0 0
Tennessee
Country [12] 0 0
United States of America
State/province [12] 0 0
Texas
Country [13] 0 0
United States of America
State/province [13] 0 0
Vermont
Country [14] 0 0
United States of America
State/province [14] 0 0
Virginia
Country [15] 0 0
United States of America
State/province [15] 0 0
Washington
Country [16] 0 0
France
State/province [16] 0 0
Paris CEDEX 05
Country [17] 0 0
Spain
State/province [17] 0 0
Barcelona

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

Ethics approval
Ethics application status

Summary
Brief summary
The reason for this study is to see if the study drug LY3484356 alone or in combination with
abemaciclib is safe and effective in participants with advanced or metastatic breast cancer
or endometrial cancer.
Trial website
https://clinicaltrials.gov/show/NCT04188548
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
There may be multiple sites in this clinical trial. 1-877-CTLILLY (1-877-285-4559) or
Address 0 0
Country 0 0
Phone 0 0
1-317-615-4559
Fax 0 0
Email 0 0
Clinicaltrials.gov@lilly.com
Contact person for scientific queries

Summary results
For IPD and results data, please see https://clinicaltrials.gov/show/NCT04188548