A Study of LOXO-783 in Patients With Breast Cancer/Other Solid Tumors
a study on Breast Cancer Solid Tumor
Summary
- Eligibility
- for people ages 18 years and up (full criteria)
- Location
- at UCLA UCSF
- Dates
- study startestimated completion
Description
Summary
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.
Official Title
A Study of LOXO-783 Administered as Monotherapy and in Combination With Anticancer Therapies for Patients With Advanced Breast Cancer and Other Solid Tumors With a PIK3CA H1047R Mutation
Keywords
Breast Cancer, Breast Neoplasms, Paclitaxel, Letrozole, Fulvestrant, Anastrozole, Exemestane, LOXO-783, Imlunestrant, Abemaciclib, Anastrozole, Exemestane, or Letrozole
Eligibility
You can join if…
Open to people ages 18 years and up
- 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
- Part A:
You CAN'T join if...
- 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
Locations
- UCSF
accepting new patients
San Francisco California 94158 United States - UCLA
accepting new patients
Santa Monica California 90404 United States - Stanford University
accepting new patients
Palo Alto California 94305 United States
Details
- Status
- accepting new patients
- Start Date
- Completion Date
- (estimated)
- Sponsor
- Eli Lilly and Company
- Links
- A Study of LOXO-783 in Patients With Breast Cancer/Other Solid Tumors
- ID
- NCT05307705
- Phase
- Phase 1 research study
- Study Type
- Interventional
- Participants
- Expecting 400 study participants
- Last Updated