None listed
Conditions
Interventions
U3-1287 will be provided as a sterile, frozen solution.
Each glass vial will contain study medication with a concentration of 70 mg/mL. Each vial is designed for
single use only and is not to be
Sponsors
DAIICHI SANKYO PHARMA DEVELOPMENT,
Eligibility
Sex/Gender
Female
Age
18 Years to 100 Years
Inclusion criteria
Inclusion criteria: Subjects must satisfy all of the following criteria to be included in the study: 1. Women ≥ 18 years old. 2. Histologically or cytologically confirmed adenocarcinoma of the breast with metastatic disease and at least 1 measureable lesion per RECIST guidelines Version 1.1. 3. Documented HER2+ disease as measured by fluorescence in situ hybridization (FISH) or immunohistochemistry (IHC) (3+). 4. Eastern Cooperative Oncology Group (ECOG) performance status 0 or 1. 5. Hematological function, as follows: -Absolute neutrophil count (ANC) ≥ 1.5 x 10^9/L - Platelet count ≥ 100 x 10^9/L - Hemoglobin ≥ 9 g/dL. 6. Renal function, as follows: - Calculated creatinine clearance ≥ 60 mL/min using the modified Cockroft-Gault equation. 7. Hepatic function, as follows: - Aspartate aminotransferase (AST) ≤ 2.5 x the upper limit of normal (ULN) (if liver metastases are present, < 5 x ULN) - Alanine aminotransferase (ALT) ≤ 2.5 x ULN (if liver metastases are present, < 5 x ULN) - Alkaline phosphatase ≤ 2.0 x ULN (if bone or liver metastases are present, < 5 x ULN) - Bilirubin ≤ 1.5 x ULN. 8. Prothrombin time (PT) and partial thromboplastin time (PTT) ≤ 1.5 x ULN. 9. Availability of archived tumor sample or fresh tumor specimen (does not have to be provided by treatment start) to confirm HER2 status and for tumor biomarkers/mutation analysis. 10. Subjects must be postmenopausal (no menstrual period for a minimum of 12 months) or surgically sterile, or must use maximally effective birth control during the period of therapy, and be willing to use contraception for 6 months following the last investigational drug dose and have a negative urine or serum pregnancy test upon entry into this study if subject is of childbearing potential. Partners of subjects must be surgically sterile or willing to use a double barrier contraception method upon enrollment, during the course of the study, and for 6 months after the last investigational drug dose received. 11. Subjects must be willing and able to comply with scheduled visits, treatment plan, laboratory tests, and other study procedures. 12. Subjects must be competent and able to comprehend, sign, and date an Independent Ethics Committee (IEC)- or Institutional Review Board (IRB)-approved informed consent form (ICF) before performance of any study-specific procedures or tests.
Exclusion criteria
Exclusion criteria: Subjects who meet any of the following criteria will be disqualified from entering the study: 1. Prior treatment for metastatic disease other than radiation therapy. Neoadjuvant/adjuvant therapy with paclitaxel, and/or docetaxel, and/or trastuzumab is allowed if completed more than 12 months prior to relapse/progression. 2. Clinically active brain metastases, defined as untreated symptomatic, or requiring therapy with steroids or anticonvulsants to control associated symptoms. Subjects with treated brain metastases that are no longer symptomatic and require no treatment with steroids or anticonvulsants may be included in the study if they have recovered from the acute toxic effect of radiotherapy. 3. Left ventricular ejection fraction (LVEF) 100 mmHg or systolic blood pressure > 140 mmHg). Use of antihypertensive medications is permissible to maintain blood pressure within the required parameters. 7. Clinically significant electrocardiogram (ECG) changes that obscure the ability to assess the RR, PR, QT, QTc and QRS intervals. Subjects with left bundle branch block, atrial fibrillation and use of a cardiac pacemaker specifically will be excluded. 8. Ascites or pleural effusion requiring chronic medical intervention. 9. Pre-existing peripheral neuropathy > grade 1. 10. Myocardial infarction, symptomatic congestive heart failure (CHF) (New York Heart Association > Class II), unstable angina, or unstable cardiac arrhythmia requiring medication within 1 year before enrollment. 11. Use of cytochrome P450 (CYP) 3A4 (CYP3A4) or CYP2C8 inducers within 28 days prior to Day 1, use of CYP3A4 or CYP2C8 inhibitors within 14 days prior to Day 1, or concurrent use of CYP3A4 or CYP2C8 inducers or inhibitors. 12. Use of amiodarone within 6 months prior to enrollment. 13. Concurrent use of antiarrhythmic medications. 14. Participated in clinical drug studies within 4 weeks (2 weeks for small molecule tyrosine kinase inhibitors; 6 weeks for mitomycin C and nitrosoureas) before study drug treatment. Current participation in other investigational protocols or procedures. 15. Uncontrolled infection requiring IV antibiotics, antivirals, or antifungals. 16. Known human immunodeficiency virus (HIV) infection, or active hepatitis B or C infection. 17. History of hypersensitivity to any of the study drugs or to any excipients. 18. Serious intercurrent medical or psychiatric illnesses or any other conditions that in the opinion of the Investigator would impair the ability to give informed consent or unacceptably reduce protocol compliance or safety of the study treatment. 19. Pregnant, breastfeeding, or unwilling/unable to use acceptable contraception. 20. QTc interval > 450 msec by Friderica’s formula on two successive screening measurements (second measu
Countries
Argentina, Brazil, Chile, Peru
Contacts
Public ContactLeopoldo Valdez
ACTIVA CRO PERU SOCIEDAD ANONIMA CERRADA
Outcome results
None listed