Status:
UNKNOWN
Clinical Study of Decitabine and Paclitaxel Combination Therapy
Lead Sponsor:
Dong Wha Pharmaceutical Co. Ltd.
Conditions:
Advanced Breast Cancer
Eligibility:
FEMALE
19+ years
Phase:
PHASE1
Brief Summary
Phase Ib clinical study of Decitabine and Paclitaxel combination therapy
Detailed Description
An open-labelled, parallel, multiple ascending dose, phase Ib clinical study of Decitabine and Paclitaxel combination therapy in treating patients with metastatic and locally advanced breast cancer
Eligibility Criteria
Inclusion
- age ≥ 19 years as female
- be unable to operate for therapy with HER2 negative breast adenocarcinoma and metastatic breast cancer, one or more chemotherapy
- according to RECIST ver.1.1, one or more evaluable lesion
- Eastern cooperative oncology group(ECOG) performance score is o or 1
- lesion for core biopsy
- Within 28days of planned first study treatment day, laboratory safety test is satisfied. ANC ≥1500cells/microliter, Platelet count ≥ 100,000 cells/microliter, Hemoglobin≥8.5g/dl, ALT and AST ≤ 2ULN, ALP≤2.5ULN, Serum total bilirubin≤1.25 ULN, PT-INR and aPTT≤1.5ULN, Creatinine≥50ml/min
- menopause or informed that effective contraception must be used during the entire treatment period of this study and for 6 months after exiting from the study
- Given signed and dated written informed consent form
Exclusion
- Symptomatic metastasis and Leptomeningeal metastasis
- Injection of paclitaxel for metastatic breast cancer within 6 months
- HER2, Positive Breast adenocarcinoma
- cancertherapy for whole body within 3 weeks
- radiotherapy for metastatic region within 4 weeks
- major surgery, open biopsy and trauma within 4 weeks
- less than 4 weeks post major surgery
- treatment with consistently systemic corticosteroid or immunosuppressive drug
- more than 2 grade for peripheral neuropathy
- Congenital ling QT syndrome or QTc interval \> 480 milisecond
- occur myocardial infartion within 6 months
- unstable angina pectoris
- HIV(+) or AIDS
- HBsAg(+) or HCV(+)
- treatment bisphosphonate for hypercalcemia
- except metastatic and locally advanced breast cancer, personal history with malignancy within 5 years
- hypersensitivity reaction with paclitaxel or Cremophor EL formulation
- Pregnant or breast feeding
- be unable or unwilling to abide by the study protocol or to cooperate fully with the investigator or designee
Key Trial Info
Start Date :
March 28 2017
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
May 1 2018
Estimated Enrollment :
18 Patients enrolled
Trial Details
Trial ID
NCT03282825
Start Date
March 28 2017
End Date
May 1 2018
Last Update
January 23 2018
Active Locations (1)
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1
Yonsei University Health System, Severance Hospital
Seoul, South Korea, 03722