The main purpose of this study is to learn more about the safety, side effects, and effectiveness of LOXO-783. LOXO-783 may be used to treat breast cancer and other solid tumors that have a change in a particular gene (known as the PIK3CA gene). Participation could last up to 36 months (3 years) and possibly longer if the disease does not get worse.
Eligibility
Sex
ALL
Min age
18 Years
Max age
—
Healthy volunteers
No
Inclusion Criteria:
* Have advanced breast cancer or another solid tumor with the presence of a phosphatidylinositol 3-kinase catalytic subunit alpha (PIK3CA) H1047R mutation (or other Sponsor and safety review committee (SRC)-approved, activating PIK3CA mutations other than H1047R mutation)
* Have adequate archival tumor tissue sample available or be approved by the Sponsor for enrollment if no tumor sample is available.
* Have stopped all cancer treatment and have recovered from the major side effects
* Have adequate organ function, as measured by blood tests
* Have a performance status of 0 or 1 on the Eastern Cooperative Oncology Group (ECOG) scale
* Patients must have
* Measurable disease
\--- Patients with non-breast tumor types must have at least 1 measurable lesion
* Non-measurable bone disease (at least 1 bone lesion in breast cancer patients only)
* For patients with an estrogen receptor (ER)+ breast cancer diagnosis:
* If female, must be postmenopausal
* If male, must agree to use hormone suppression
* Phase 1a:
\-- Dose escalation and backfill patients:
* Advanced solid tumor
* Patients may have had up to 5 prior regimens for advanced disease
* Phase 1b:
* Part A:
* ER+/human epidermal growth factor receptor 2 (HER2)- advanced breast cancer
* Patients may have had up to 5 prior regimens for advanced disease ---- Prior cyclin dependent kinase (CDK)4/6 inhibitor therapy required
* Part B:
* ER+/HER2- advanced breast cancer
* Patients may have had up to 2 prior regimens for advanced disease.
* Part C:
* ER+/HER2- advanced breast cancer
* Patients may have had up to 5 prior regimens for advanced disease.
\---- Prior CDK4/6 inhibitor therapy required.
* Have a diagnosis of diabetes mellitus Type 2
* Part D:
* Advanced breast cancer
* Patients may have had up to 5 prior regimens for advanced disease.
* Part E:
* Advanced solid tumor
* Patients may have had up to 3 prior regimens for advanced disease advanced disease
* Part F:
* ER+/HER2- advanced breast cancer
* Patients may have had up to 5 prior regimens for advanced disease
* Prior cyclin dependent kinase (CDK)4/6 inhibitor therapy required
Exclusion Criteria:
* Medical Conditions
* Colorectal cancer
* Endometrial cancers with specific concurrent oncogenic alterations
* A history of known active or suspected
* Diabetes mellitus Type 1 or
* Diabetes mellitus Type 2 requiring antidiabetic medication (Phase 1a and all parts of Phase 1b except Part C).
* Serious concomitant systemic disorder
* Known or suspected history of untreated or uncontrolled central nervous system (CNS) involvement.
* Active uncontrolled systemic bacterial, viral, fungal, or parasitic infection, or other clinically significant active disease process
* Prior exposure to phosphatidylinositol 3-kinase/protein kinase B/mammalian target of rapamycin (PI3K/AKT/mTOR) inhibitor(s), except in certain circumstances
Primary outcome measure(s)
Phase 1 a: To determine the maximum tolerated dose/recommended phase 2 dose (MTD/RP2D) of LOXO-783: Number of patients with dose-limiting toxicities (DLTs) — During the first 28-day cycle of LOXO-783 treatment Number of patients with DLTs
Phase 1 a: To determine the MTD/RP2D of LOXO-783: Number of patients with DLT-equivalent toxicities — During the first 28-day cycle of LOXO-783 treatment Number of patients with DLT-equivalent toxicities
Trial sites (50)
Facility
City
Region
Status
Mayo Clinic of Scottsdale
Scottsdale
Arizona
Not Yet Recruiting
UCLA Medical Center
Los Angeles
California
Completed
UCSF Medical Center at Mission Bay
San Francisco
California
Recruiting
Stanford University Hospital
Stanford
California
Recruiting
Mayo Clinic
Jacksonville
Florida
Not Yet Recruiting
Winship Cancer Center Emory University
Atlanta
Georgia
Completed
Massachusetts General Hospital
Boston
Massachusetts
Completed
Dana-Farber Cancer Institute
Boston
Massachusetts
Not Yet Recruiting
Mayo Clinic
Rochester
Minnesota
Recruiting
Washington University Medical School
St Louis
Missouri
Not Yet Recruiting
Memorial Sloan Kettering Cancer Center
New York
New York
Completed
Wilmot Cancer Institute
Rochester
New York
Not Yet Recruiting
Tennessee Oncology PLLC
Nashville
Tennessee
Completed
Texas Oncology-Baylor Charles A. Sammons Cancer Center
Dallas
Texas
Not Yet Recruiting
UT Southwestern Medical Center
Dallas
Texas
Recruiting
University of Texas MD Anderson Cancer Center
Houston
Texas
Not Yet Recruiting
South Texas Accelerated Research Therapeutics (START)
This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.
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