A Study of LOXO-783 in Patients With Breast Cancer/Other Solid Tumors
- Conditions
- Breast Cancer
- Registration Number
- JPRN-jRCT2031220276
- Lead Sponsor
- Masaki Takeshi
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Recruiting
- Sex
- All
- Target Recruitment
- 260
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
-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
-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
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method
- Secondary Outcome Measures
Name Time Method