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Trial record 1 of 1 for:    LY3484356
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A Study of LY3484356 in Participants With Advanced or Metastatic Breast Cancer or Endometrial Cancer

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT04188548
Recruitment Status : Recruiting
First Posted : December 6, 2019
Last Update Posted : June 11, 2020
Sponsor:
Information provided by (Responsible Party):
Eli Lilly and Company

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.

Condition or disease Intervention/treatment Phase
Breast Cancer Advanced Breast Cancer Metastatic Breast Cancer Endometrial Cancer Drug: LY3484356 Drug: Abemaciclib Phase 1

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 186 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official 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
Actual Study Start Date : December 10, 2019
Estimated Primary Completion Date : October 28, 2022
Estimated Study Completion Date : April 26, 2023

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Breast Cancer
Drug Information available for: Abemaciclib

Arm Intervention/treatment
Experimental: Dose Escalation LY3484356
LY3484356 given orally.
Drug: LY3484356
Administered orally

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

Drug: Abemaciclib
Administered orally
Other Name: LY2835219

Experimental: Dose Expansion LY3484356
LY3484356 given orally.
Drug: LY3484356
Administered orally

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

Drug: Abemaciclib
Administered orally
Other Name: LY2835219




Primary Outcome Measures :
  1. Number of Participants with Dose Limiting Toxicities (DLTs) [ Time Frame: Baseline through Cycle 1 (28 Day Cycle) ]
    Number of Participants with DLTs


Secondary Outcome Measures :
  1. Pharmacokinetics (PK): Area Under the Concentration Time Curve (AUC) of LY3484356 [ Time Frame: Predose Cycle 1 Day 1 through Predose Cycle 2 Day 1 (28 Day Cycles) ]
    PK: AUC of LY3484356

  2. PK: Maximum Concentration (Cmax) of LY3484356 [ Time Frame: Predose Cycle 1 Day 1 through Predose Cycle 2 Day 1 (28 Day Cycles) ]
    PK: Cmax of LY3484356

  3. PK: AUC of LY3484356 in Combination with Abemaciclib [ Time Frame: Predose Cycle 1 Day 1 through Predose Cycle 2 Day 1 (28 Day Cycles) ]
    PK: AUC of LY3484356 in Combination with Abemaciclib

  4. PK: Cmax of LY3484356 in Combination with Abemaciclib [ Time Frame: Predose Cycle 1 Day 1 through Predose Cycle 2 Day 1 (28 Day Cycles) ]
    PK: Cmax of LY3484356 in Combination with Abemaciclib

  5. Overall Response Rate (ORR): Percentage of Participants with Complete Response (CR) or Partial Response (PR) [ Time Frame: Baseline through Disease Progression or Death (Estimated up to 42 Months) ]
    ORR: Percentage of Participants with CR or PR

  6. Duration of Response (DoR) [ Time Frame: Date of CR or PR to Date of Objective Disease Progression or Death Due to Any Cause (Estimated up to 42 Months) ]
    DoR

  7. Disease Control Rate (DCR): Percentage of Participants with a Best Overall Response of CR, PR, and Stable Disease [ Time Frame: Baseline through Measured Progressive Disease (Estimated up to 42 Months) ]
    DCR: Percentage of Participants with a Best Overall Response of CR, PR, and Stable Disease

  8. Progression Free Survival (PFS) [ Time Frame: Baseline to Objective Progression or Death Due to Any Cause (Estimated up to 42 Months) ]
    PFS



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04188548


Contacts
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Contact: There may be multiple sites in this clinical trial. 1-877-CTLILLY (1-877-285-4559) or 1-317-615-4559 Clinicaltrials.gov@lilly.com

Locations
Show Show 28 study locations
Sponsors and Collaborators
Eli Lilly and Company
Investigators
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Study Director: 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
Additional Information:
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Responsible Party: Eli Lilly and Company
ClinicalTrials.gov Identifier: NCT04188548    
Other Study ID Numbers: 17502
J2J-MC-JZLA ( Other Identifier: Eli Lilly and Company )
2019-003581-41 ( EudraCT Number )
First Posted: December 6, 2019    Key Record Dates
Last Update Posted: June 11, 2020
Last Verified: June 2020
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Breast Neoplasms
Endometrial Neoplasms
Neoplasms by Site
Neoplasms
Breast Diseases
Skin Diseases
Uterine Neoplasms
Genital Neoplasms, Female
Urogenital Neoplasms
Uterine Diseases
Genital Diseases, Female