Locally advanced/metastatic solid tumors, PIK3CA-mutated HR+/HER2- inoperable/recurrent BC
Conditions
Interventions
Inavolisib: Administer 6mg or 9mg orally once daily.
Palbociclib: Administer the standard dose orally.
fulvestrant: Two tubes of this drug (containing 500 mg as fulvestrant) will be administered intra
Sponsors
Iwasa Satoru
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: [Common for Stages 1 and 2] - Patients with ECOG performance status of 0 or 1 - Patients with adequate hematological and organ function within 14 days prior to the start of investigational drug administration [Stage 1 only] - Patients with locally advanced or metastatic solid tumors for whom standard therapy is not available or has been ineffective - Patients with evaluable or measurable lesions based on RECIST version 1.1 [Stage 2 only] - Breast cancer patients with confirmed HR-positive and HER2-negative diagnosis - Patients with inoperable or metastatic breast cancer not amenable to curative treatment - Patients confirmed to have PIK3CA mutations by central laboratory testing - Patients with expected survival exceeding 6 months - Patients whose disease progressed during adjuvant endocrine therapy with an aromatase inhibitor or tamoxifen, or within 12 months after completion of adjuvant endocrine therapy - Patients with measurable lesions based on RECIST version 1.1. Patients with only evaluable bone lesions are ineligible. However, patients with only bone lesions are eligible if they have lytic or mixed lytic/blastic lesions with at least one measurable soft tissue component according to RECIST version 1.1. - For premenopausal or perimenopausal female patients, those who started LHRH agonist therapy at least 2 weeks prior to Cycle 1 Day 1.
Exclusion criteria
Exclusion criteria: [Common for Stages 1 and 2] - Patients with complication or history of leptomeningeal disease - Patients with type 2 diabetes requiring ongoing systemic treatment at the time of study entry; or patients with any history of Type 1 diabetes. - Patients with untreated or active central nervous system metastases - Patients with active inflammatory or infectious disease in either eye, or complications requiring surgical procedures during the trial period - Patients requiring daily oxygen supplementation - Patients with a history or complication of inflammatory bowel disease, or patients with active intestinal inflammation - Patients with significant trauma within 28 days prior to the start of investigational drug administration - Patients with symptomatic active lung disease - Patients with prior treatment with PI3K, AKT or mTOR inhibitors, or drugs with a mechanism of action that inhibits the PI3K-AKT-mTOR pathway [Stage 2 only] - Patients with metaplastic breast cancer - Patients with complication or history of carcinomatous meningitis - Patients with prior systemic therapy for metastatic breast cancer - Patients who received chemotherapy, radiation therapy, or other anticancer treatment within 14 days prior to the start of investigational drug administration - Patients with prior treatment with fulvestrant or selective ER degraders. However, patients who received fulvestrant or selective ER degraders only as part of neoadjuvant therapy for a period not exceeding 6 months are excluded from this criterion - Patients who received investigational treatments within 4 weeks prior to the start of investigational drug administration - Patients who received radiation therapy to more than 25% of bone marrow, hematopoietic stem cell transplantation, or bone marrow transplantation - Patients receiving chronic corticosteroid therapy or immunosuppressants
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| safety, efficacy, phamacokinetics [Stage 1] - Tolerability (DLT) - Safety (adverse events, etc.) - Pharmacokinetics (plasma inavolisib concentration, etc.) [Stage 2] - Efficacy (ORR as determined by an independent review committee) | — |
Secondary
| Measure | Time frame |
|---|---|
| safety, efficacy, phamacokinetics [Stage 1] - Efficacy (ORR as determined by the investigator/sub-investigator) [Stage 2] - Efficacy (ORR as determined by the investigator/sub-investigator, OS, etc.) - Safety (adverse events, etc.) - Pharmacokinetics (plasma inavolisib concentration, etc.) | — |
Contacts
Public ContactClinical trials information
Chugai Pharmaceutical Co., Ltd.
Outcome results
None listed