J4C-OX-JZUA - 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.

Studio Clinico

Patologia: Neoplasie della mammella, Altre neoplasie

Osservazionale-Sperimentale: Sperimentale

Monocentrico-Multicentrico: Monocentrico

Randomizzato: No

Fase di studio: 1,

Linee di trattamento: Seconda linea, Terza/N linea

Criteri di inclusione: 

- 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

Criteri di esclusione: 

- 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.

Trattamento sperimentale: 

Loxo-783

Trattamento di controllo: 

Anticancer therapies (Fulvestrant, Imlunestrant, Abemaciclib, Anastrozole, Exemestane, or Letrozole)

Centri partecipanti

Nord Italia

Informazioni Generali

Protocollo

Numero di iscrizione a registro: 2022-000175-40

Data di inserimento: 29.05.2024

Promotore

Eli Lilly and Company

Principal Investigator ITALIA

Istituto Europeo di Oncologia, Milano

Riferimento: Prof. Giuseppe Curigliano

Telefono: 0257489599

Email: giuseppe.curigliano@ieo.it

Localita: Milano