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A Study of LOXO-783 in Patients With Breast Cancer/Other Solid Tumors
A Study of LOXO-783 in Patients With Breast Cancer/Other Solid Tumors
RecruitingPhase 1
Sponsor: Eli Lilly and Company
Conditions: Breast Cancer
Interventions: LOXO-783, Fulvestrant, Imlunestrant, Abemaciclib, Anastrozole, Exemestane, or Letrozole
Countries: United States, Australia, Belgium, Canada, China, France, Germany, Japan
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 overview
Sex: ALL
Age: 18 Years to —
Healthy volunteers: No
Study type: INTERVENTIONAL
Eligibility criteria
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 circumstancesLocations (50)
- Scottsdale, Arizona, United States
- Los Angeles, California, United States
- San Francisco, California, United States
- Stanford, California, United States
- Jacksonville, Florida, United States
- Atlanta, Georgia, United States
- Boston, Massachusetts, United States
- Boston, Massachusetts, United States
- Rochester, Minnesota, United States
- St Louis, Missouri, United States
- New York, New York, United States
- Rochester, New York, United States
- Nashville, Tennessee, United States
- Dallas, Texas, United States
- Dallas, Texas, United States
- Houston, Texas, United States
- San Antonio, Texas, United States
- Adelaide, Australia
- East Melbourne, Australia
- Sydney, Australia
- Anderlecht, Belgium
- Leuven, Belgium
- Toronto, Canada
- Vancouver, Canada
- Beijing, China
- Nanchang, China
- Shanghai, China
- Lyon, France
- Paris, France
- Saint-Herblain, France
- + 20 more on CT.gov