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Clinical Trial Details — Status: Active, not recruiting

Administrative data

NCT number NCT04188548
Other study ID # 17502
Secondary ID J2J-MC-JZLA2019-
Status Active, not recruiting
Phase Phase 1
First received
Last updated
Start date December 10, 2019
Est. completion date December 2027

Study information

Verified date May 2024
Source Eli Lilly and Company
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial Summary

The reason for this study is to see if the study drug LY3484356 alone or in combination with other anticancer therapies is safe and effective in participants with advanced or metastatic breast cancer or endometrial cancer.


Recruitment information / eligibility

Status Active, not recruiting
Enrollment 500
Est. completion date December 2027
Est. primary completion date June 29, 2020
Accepts healthy volunteers No
Gender All
Age group 18 Years and older
Eligibility Inclusion Criteria: All study parts: - 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 Dose escalation- Participants must have one of the following: - Parts A and B: ER+ HER2- breast cancer with evidence of locally advanced unresectable or metastatic disease who have had the following: - Part A: may have had up to 1 prior regimen of any kind for in the advanced/metastatic setting and no prior cyclin-dependent kinase 4/6 (CDK4/6) inhibitor therapy. - Part B: may have had up to 2 prior regimens, no more than 1 of which may be endocrine therapy in the advanced/metastatic setting, and must have received a prior CDK4/6 inhibitor - Cohort E4: No prior everolimus. - Cohort E5: No prior alpelisib and must have a phosphatidylinositol 3-kinase catalytic a (PIK3Ca) mutation as determined by local testing. - Part C: ER+, human epidermal growth factor receptor 2 positive (HER2+) breast cancer with evidence of locally advanced unresectable or metastatic disease who have had at least 2 HER2-directed therapies in any setting. - Part D: ER+, EEC that has progressed after platinum containing chemotherapy and no prior fulvestrant or aromatase inhibitor therapy. - Part E: ER+ and HER2+ breast cancer with evidence of locally advanced, unresectable, or metastatic disease. - Part E: Participants must have received induction taxane chemotherapy combined with trastuzumab + pertuzumab as first-line treatment for advanced/metastatic disease and must not have progressed on this regimen. - Part E: Participants must not have received more than 1 HER2-directed regimen or any endocrine therapy for advanced disease or any prior CDK4/6 inhibitor therapy. Participants with ER+/HER2- breast cancer enrolled in this study must have had evidence of clinical benefit while on endocrine therapy for at least 24 months in the adjuvant setting or at least 6 months in the advanced/metastatic setting or have untreated de novo metastatic breast cancer 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 unstable - Participants must not be pregnant or breastfeeding

Study Design


Intervention

Drug:
LY3484356
Administered orally
Abemaciclib
Administered orally
Everolimus
Administered orally
Alpelisib
Administered orally
Trastuzumab
Administered intravenously
Aromatase Inhibitor (AI)
Anastrozole or Exemestane or Letrozole administered orally (physician choice)
Pertuzumab
Administered intravenously

Locations

Country Name City State
Australia Cancer Research SA Adelaide South Australia
Australia St Vincent's Hospital Sydney Darlinghurst New South Wales
Australia Breast Cancer Research Centre-WA Nedlands Western Australia
Australia Linear Clinical Research Nedlands Western Australia
Australia Calvary Mater Newcastle Waratah New South Wales
Belgium Institut Jules Bordet Anderlecht Bruxelles-Capitale, Région De
Belgium Antwerp University Hospital Edegem Antwerpen
Belgium UZ Leuven Leuven
France Institut Curie Paris
France Institut de cancérologie Strasbourg Europe (ICANS) Strasbourg
Japan Hyogo Cancer Center Akashi Hyogo
Japan National Cancer Center Hospital Chuo-ku Tokyo
Korea, Republic of Asan Medical Center Seoul Seoul-teukbyeolsi [Seoul]
Korea, Republic of Samsung Medical Center Seoul
Korea, Republic of Seoul National University Hospital Seoul Seoul, Korea
Korea, Republic of Severance Hospital, Yonsei University Health System Seoul Korea
Spain Hospital Clínic de Barcelona Barcelona Catalunya [Cataluña]
Spain Hospital Universitari Vall d'Hebron Barcelona
Spain Hospital Clinico San Carlos Madrid
Spain Hospital General Universitario Gregorio Marañon Madrid
Spain Hospital Universitario 12 de Octubre Madrid Madrid, Comunidad De
Spain Hospital Universitario Fundación Jiménez Díaz Madrid
Spain Hospital Universitario HM Sanchinarro Madrid
Spain Hospital Universitario Ramón y Cajal Madrid
Spain Fundación Instituto Valenciano de Oncología Valencia
Spain Hospital Clínico Universitario de Valencia Valencia Valenciana, Comunitat
Taiwan Kaohsiung Medical University Hospital Kaohsiung
Taiwan China Medical University Hospital Taichung
Taiwan National Cheng-Kung Uni. Hosp. Tainan
Taiwan Mackay Memorial Hospital Taipei
Taiwan National Taiwan University Hospital Taipei
Taiwan Taipei Veterans General Hospital Taipei
United States Winship Cancer Center Emory University Atlanta Georgia
United States Johns Hopkins University Baltimore Maryland
United States Beverly Hills Cancer Center Beverly Hills California
United States Dana-Farber Cancer Institute Boston Massachusetts
United States Massachusetts General Hospital Boston Massachusetts
United States The University of Vermont Medical Center Inc. Burlington Vermont
United States University of North Carolina School of Medicine Chapel Hill North Carolina
United States Northwestern University Chicago Illinois
United States Ohio State University Medical Center Columbus Ohio
United States Memorial Sloan Kettering Cancer Center Commack New York
United States Texas Oncology-Baylor Charles A. Sammons Cancer Center Dallas Texas
United States UT Southwestern Med Center Dallas Texas
United States Duke University Durham North Carolina
United States Inova Schar Cancer Institute Fairfax Virginia
United States Banner MD Anderson Cancer Center Gilbert Arizona
United States UPMC Hillman Cancer Center Harrisburg Harrisburg Pennsylvania
United States University of Texas MD Anderson Cancer Center Houston Texas
United States Community Cancer Center North Indianapolis Indiana
United States Mayo Clinic in Florida Jacksonville Florida
United States Asante Rogue Regional Medical Center Medford Oregon
United States Minnesota Oncology/Hematology PA Minneapolis Minnesota
United States Memorial Sloan Kettering - Bergen Montvale New Jersey
United States SCRI Oncology Partners Nashville Tennessee
United States Tennessee Oncology Nashville Nashville Tennessee
United States Vanderbilt Health One Hundred Oaks Nashville Tennessee
United States Memorial Sloan Kettering Cancer Center New York New York
United States University of Oklahoma Health Sciences Center, Stephenson Cancer Center Oklahoma City Oklahoma
United States University of California, Irvine Orange California
United States Lake Nona DDU Orlando Florida
United States Mayo Clinic in Arizona - Phoenix Phoenix Arizona
United States Rhode Island Hospital Providence Rhode Island
United States Mayo Clinic Rochester Minnesota
United States Wilmot Cancer Institute Rochester New York
United States Washington University Saint Louis Missouri
United States South Texas Accelerated Research Therapeutics (START) San Antonio Texas
United States UCSF Medical Center at Mission Bay San Francisco California
United States Seattle Cancer Care Alliance Seattle Washington
United States Highlands Oncology Group Springdale Arkansas
United States Minnesota Oncology/Hematology PA The Woodlands Texas
United States Oncology and Hematology Associates of Southwest Virginia Inc The Woodlands Texas
United States Texas Oncology - San Antonio Medical Center The Woodlands Texas
United States US Oncology The Woodlands Texas
United States USO-Rocky Mountain Cancer Center The Woodlands Texas
United States Texas Oncology - Tyler Tyler Texas

Sponsors (1)

Lead Sponsor Collaborator
Eli Lilly and Company

Countries where clinical trial is conducted

United States,  Australia,  Belgium,  France,  Japan,  Korea, Republic of,  Spain,  Taiwan, 

Outcome

Type Measure Description Time frame Safety issue
Primary Number of Participants with Dose Limiting Toxicities (DLTs) and DLT-Equivalent Toxicities Number of Participants with DLTs and DLT-Equivalent Toxicities Baseline through Cycle 1 (21/28 Day Cycle)
Secondary Pharmacokinetics (PK): Area Under the Concentration Time Curve (AUC) of LY3484356 PK: AUC of LY3484356 Predose Cycle 1 Day 1 through Predose Cycle 2 Day 1 (21/28 Day Cycles)
Secondary PK: Maximum Concentration (Cmax) of LY3484356 PK: Cmax of LY3484356 Predose Cycle 1 Day 1 through Predose Cycle 2 Day 1 (21/28 Day Cycles)
Secondary PK: AUC of LY3484356 in Combination with Other Anticancer Therapies PK: AUC of LY3484356 in Combination with Other Anticancer Therapies Predose Cycle 1 Day 1 through Predose Cycle 2 Day 1 (21/28 Day Cycles)
Secondary PK: Cmax of LY3484356 in Combination with Other Anticancer Therapies PK: Cmax of LY3484356 in Combination with Other Anticancer Therapies Predose Cycle 1 Day 1 through Predose Cycle 2 Day 1 (21/28 Day Cycles)
Secondary Overall Response Rate (ORR): Percentage of Participants with Confirmed Complete Response (CR) or Partial Response (PR) as per Response Evaluation Criteria in Solid Tumors (RECIST) v1.1 ORR: Percentage of Participants with Confirmed CR or PR as per RECIST v1.1 Baseline through Disease Progression or Death (Estimated up to 28 Months)
Secondary Duration of Response (DoR): Time From the Date of First Evidence of CR, PR (per RESIST v1.1) to the Date of Objective Progression or Death Due to Any Cause, Whichever is Earlier DoR: Time From the Date of First Evidence of CR, PR (per RESIST v1.1) to the Date of Objective Progression or Death Due to Any Cause, Whichever is Earlier Date of CR or PR to Date of Objective Disease Progression or Death Due to Any Cause (Estimated up to 28 Months)
Secondary Disease Control Rate (DCR): Percentage of Participants with a Best Overall Response (BOR) of CR, PR, and Stable Disease (SD) as per RECIST v1.1 DCR: Percentage of Participants with a BOR of CR, PR, and SD as per RECIST v1.1 Baseline through Measured Progressive Disease (Estimated up to 28 Months)
Secondary Clinical Benefit Rate (CBR): Percentage of Participants with a BOR of CR or PR, or SD lasting =24 weeks as per RECIST v1.1 CBR: Percentage of Participants with a BOR of CR or PR, or SD lasting =24 weeks as per RECIST v1.1 Baseline through Measured Progressive Disease (Estimated up to 28 Months)
Secondary Progression Free Survival (PFS): Time From Baseline to the Date of Objective Progression or Death Due to Any Cause, Whichever is Earlier PFS: Time From Baseline to the Date of Objective Progression or Death Due to Any Cause, Whichever is Earlier Baseline to Objective Progression or Death Due to Any Cause (Estimated up to 28 Months)
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