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)
Istituto Europeo di Oncologia
Via Ripamonti 435 - 20141 Milano - MI
Riferimento: Prof. Giuseppe Curigliano
Telefono: 0257489599
Email: giuseppe.curigliano@ieo.it
Numero di iscrizione a registro: 2022-000175-40
Data di inserimento: 29.05.2024
Eli Lilly and Company
Istituto Europeo di Oncologia, Milano
Riferimento: Prof. Giuseppe Curigliano
Telefono: 0257489599
Email: giuseppe.curigliano@ieo.it
Localita: Milano