RANDOMIZED, PLACEBO-CONTROLLED,DOUBLE-BLIND PHASE 1B/2 STUDY OF U3-1287(AMG 888) IN COMBINATION WITHTRASTUZUMAB PLUS PACLITAXEL IN NEWLYDIAGNOSED HER2-POSITIVE METASTATICBREAST CANCER (MBC)

DAIICHI SANKYO PHARMA DEVELOPMENT,0 sites0 target enrollmentStarted: August 22, 2013Last updated: September 4, 2023

Conditions

Trial Snapshot

Phase: 未知
Sponsor

Study Overview Eligibility Criteria Investigators Records & Identifiers Similar Trials

Study Overview

Brief Summary

No summary available.

Study Design

Study Type: Interventional

Eligibility Criteria

Ages: 18 to 100 (—)
Sex: Female

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
•- 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
•11. Subjects must be willing and able to comply with
•scheduled visits, treatment plan, laboratory tests,
+7 more not shown

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) < 50%.
•History of LVEF decline to < 50% on prior
•trastuzumab therapy.
•4. Therapeutic or palliative radiation therapy or major
•surgery within 4 weeks before study drug treatment.
•5. History of other malignancies, except adequately
•treated nonmelanoma skin cancer, curatively treated
•in-situ cancer, or other solid tumors curatively
•treated with no evidence of disease for ≥ 5 years.
•6. Uncontrolled hypertension (diastolic blood pressure
•> 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
+18 more not shown

Investigators

Sponsor

DAIICHI SANKYO PHARMA DEVELOPMENT,

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