Relapsed/Refractory Locally Advanced or Metastatic Breast Cancer and Triple Negative Breast Cancer
Conditions
Interventions
This is a Phase I dose escalation/expansion multi-center, open-label, non-randomized study with 2 study cohorts. The dose escalation cohort is to identify the MTD and the RP2D of QD and BID dose regim
Sponsors
Kimura Satoru
Eligibility
Sex/Gender
Female
Inclusion criteria
Inclusion criteria: Dose Escalation and Dose Expansion Cohorts 1.Female patients, >= 18 years of age at the time of obtaining informed consent. 2.Patients with a documented (histologically or cytologically proven) breast cancer that is locally advanced or metastatic. 3.Patients with a malignancy that is either relapsed/refractory to standard therapy or for which no standard therapy is available. 4.Patients with a malignancy that is currently not amenable to surgical intervention due to either medical contraindications or non-resectability of the tumor. 5.Patients with measurable or non measurable disease according to the Response Evaluation Criteria In Solid Tumor (RECIST, v1.1). 6.Patients with an Eastern Cooperative Oncology Group (ECOG) performance status (PS) of 0 or 1 (see APPENDIX B: Performance Status Evaluation). 7.Life expectancy of greater than or equal to 3 months. 8.Resolution of all chemotherapy-related or radiation-related toxicities to Grade 1 severity or lower, except for stable sensory neuropathy (less than or equal to Grade 2). 9.Patients who are either not of childbearing potential or who agree to use a medically effective method of contraception during the study and during 3 months after the last dose of study drug. (See Appendix H: Forms of contraception). 10.Patients with the ability to understand and give written informed consent for participation in this trial, including all evaluations and procedures as specified by this protocol. Dose expansion Cohort for TNBC 1.Patients with conditions as follows; ER <10%, PR <10% by IHC assay, and HER2 negative based on ASCO CAP guideline 2.Patients with measurable disease according to the response evaluation criteria in TNBC (RECIST, v1.1) 3.Patients with measurable disease that can be easily accessed for biopsy. 4.Relapsed (recurrence or disease progression after achieving a documented clinical response to first- or second-line treatment) or refractory (disease progression while receiving first line or second line treatment). In the case of TNBC, prior initial therapy with at least one known active regimen for TNBC including, but not limited to, any combination of anthracyclines, taxanes, platinum agents, Ixabepilone, and/or cyclophosphamide is required.
Exclusion criteria
Exclusion criteria: Dose Escalation and Expansion Cohorts 1.Women who are pregnant or lactating. Women of child-bearing potential (WOCBP) not using adequate birth control see Appendix H: Forms of contraception. 2.Patients with known central nervous system (CNS) or leptomeningeal metastases not controlled by prior surgery, radiotherapy or requiring corticosteroids to control symptoms, or patients with symptoms suggesting CNS involvement for which treatment is required. 3.Patients with primary brain tumors. 4.Patients with any hematologic malignancy. This includes leukemia (any form), lymphoma, and multiple myeloma. 5.Patients with any of the following hematologic abnormalities at baseline. (Patients may have received a red blood cell product transfusion prior to study, if clinically warranted.): -Absolute neutrophil count (ANC) = 1.5 times the ULN for the institution value -AST or ALT >= 3 times the ULN for the institution value (>= 5 times if due to hepatic involvement by tumor) -Creatinine >= 1.5 times ULN for the institution value (or a calculated creatinine clearance 450 msec (males) or > 470 msec (females) -QTc interval = 38 degrees within 1 week prior to first study drug administration. 11.Patients with inadequate recovery from any prior surgical procedure, or patients having undergone any major surgical procedure within 4 weeks prior to first study drug administration. 12.Patients with any other life-threatening illness, significant organ system dysfunction, or clinically significant laboratory abnormality, which, in the opinion of the Investigator, would either compromise the patient's safety or interfere with evaluation of the safety of the study drug. 13.Patients with a psychiatric disorder or altered mental status that would preclude understanding of the informed consent process and/or completion of the necessary studies. 14.Patients with the inability or with foreseeable incapacity, in the opinion of the Investigator, to comply with the protocol requirements. 15.Any anti-neoplastic agent or monoclonal antibody therapy
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| To determine the maximum tolerated dose (MTD) of OTS167 administered via oral capsule (PO) to patients with relapsed or refractory locally advanced or metastatic breast cancer. | — |
Countries
Japan, United States
Contacts
Public ContactClinical Trial Desk
OncoTherapy Science, Inc.
Outcome results
None listed