Phase 1 / 2 Study of SAR439859 Single Agent and in Combination With Palbociclib in Postmenopausal Women With Estrogen Receptor Positive Advanced Breast Cancer (AMEERA-1)
- Inclusion criteria: Parts A, B, C, D and E: - Patients must be postmenopausal women - Histological diagnosis of breast adenocarcinoma - Locally advanced or metastatic disease - Either primary tumor or any metastatic site to be positive for Estrogen Receptors (ER+) and negative for HER2 (HER2-) receptor - Patients previously treated with endocrine therapy for advanced disease: at least 6 months exposure to endocrine therapy (Patients with early progression on adjuvant endocrine therapy or who progressed on adjuvant endocrine therapy within 12 months after completion are eligible), and in part D, no more than 2 prior lines of endocrine therapy are allowed - Patients previously treated with chemotherapy for advanced disease: no more than 3 prior chemotherapeutic regimens in Part A, and no more than 1 prior chemotherapeutic regimen in Parts B, C, D and E (including Antibody Drug Conjugates) - Measurable lesion Exclusion criteria: - Medical history or ongoing gastrointestinal disorders that could affect absorption of SAR439859 and/or palbociclib (including difficulties with swallowing capsules) - Patient with any other cancer (except for adequately treated basal cell or squamous cell skin cancer, in situ cervical cancer or any other cancer from which the patient has been disease free for >3 years) - Patients with known brain metastases - Treatment with anticancer agents (including investigational drugs) less than 2 weeks before first study treatment starts (less than 4 weeks if the anticancer agents were antibodies) - Prior treatment with another selective ER down-regulator (SERD) (except fulvestrant) with a washout of at least 6 weeks prior to the first study drug administration - Inadequate hematological and biochemical lab tests - Patients with Gilbert disease - Treatment with human immunodeficiency virus (HIV)-antiviral, antifungal and antioxidant agents less than 2 weeks before study treatment starts - Treatment with strong and moderate cytochrome P450 (CYP) 3A or CYP2C8 inducers within 2 weeks before first study treatment - Treatment with strong CYP3A inhibitors within 2 weeks before first study treatment starts - More than one prior cyclin-dependent kinase (CDK) 4/6 inhibitor based therapy. - No prior CDK4/6 exposure is required for patients with early progression on adjuvant endocrine therapy or who progressed on adjuvant endocrine therapy within 12 months after completion of adjuvant endocrine therapy Part A only: - Patients with liver metastases only Part D only: - Prior therapy with any selective CDK4/6 inhibitor, phosphoinositide 3-kinase (PI3K) inhibitors and mammalian target of rapamycin (mTOR) inhibitors Part E only: - Any treatment with weak CYP3A inducer and all CYP3A inhibitors within 2 weeks before midazolam administration - Any contraindications to midazolam (in accordance with the applicable label) - Use of any herbal medicines 1 week, and grapefruit juice for 72 hours before midazolam administration and up to the end of PK sampling following the last midazolam administration - Patients older than 60 years The above information is not intended to contain all considerations relevant to a patient's potential participation in a clinical trial.
Duration of the study, per patient, will include eligibility period (screening period) of up to 4 weeks (28 days), treatment period (at least 1 cycle [28 days] of study treatment), and end of treatment (EOT) visit after the last study treatment administration (i.e. at least 30 days post last treatment or until the patient receives another anticancer therapy, whichever is earlier). The expected enrollment period is approximately 36-40 months.
Trial Phase Phase I/II
Trial Type Treatment
- Primary ID TED14856
- Secondary IDs NCI-2017-01882, U1111-1189-4896, 2017-000690-36
- Clinicaltrials.gov ID NCT03284957