Advanced Breast Cancer
Conditions
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
Interventions
DRUGDecitabine
The subjects will be sequential administered with Decitabine and paclitaxel 80mg/m2 by IV(intravenous) infusion. Decitabine is starting dose of 15mg/m2 on 1D, 8D, 22D, 28D of a 28day cycle. Paclitaxel 80mg/m2 will be dosed in combination therapy with Decitabine on 8D, 22D, 28D of a 28day cycle.
DRUGPaclitaxel
The subjects will be sequential administered with Decitabine and paclitaxel 80mg/m2 by IV(intravenous) infusion. Decitabine is starting dose of 15mg/m2 on 1D, 8D, 22D, 28D of a 28day cycle. Paclitaxel 80mg/m2 will be dosed in combination therapy with Decitabine on 8D, 22D, 28D of a 28day cycle.
Sponsors
Dong Wha Pharmaceutical Co. Ltd.
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
FEMALE
Age
19 Years to No maximum
Healthy volunteers
No
Inclusion criteria
1. age ≥ 19 years as female 2. be unable to operate for therapy with HER2 negative breast adenocarcinoma and metastatic breast cancer, one or more chemotherapy 3. according to RECIST ver.1.1, one or more evaluable lesion 4. Eastern cooperative oncology group(ECOG) performance score is o or 1 5. lesion for core biopsy 6. 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 7. 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 8. Given signed and dated written informed consent form
Exclusion criteria
1. Symptomatic metastasis and Leptomeningeal metastasis 2. Injection of paclitaxel for metastatic breast cancer within 6 months 3. HER2, Positive Breast adenocarcinoma 4. cancertherapy for whole body within 3 weeks 5. radiotherapy for metastatic region within 4 weeks 6. major surgery, open biopsy and trauma within 4 weeks 7. less than 4 weeks post major surgery 8. treatment with consistently systemic corticosteroid or immunosuppressive drug 9. more than 2 grade for peripheral neuropathy 10. Congenital ling QT syndrome or QTc interval \> 480 milisecond 11. occur myocardial infartion within 6 months 12. unstable angina pectoris 13. HIV(+) or AIDS 14. HBsAg(+) or HCV(+) 15. treatment bisphosphonate for hypercalcemia 16. except metastatic and locally advanced breast cancer, personal history with malignancy within 5 years 17. hypersensitivity reaction with paclitaxel or Cremophor EL formulation 18. Pregnant or breast feeding 19. be unable or unwilling to abide by the study protocol or to cooperate fully with the investigator or designee
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Maximum Tolerant Dose (MTD) and Dose Limiting Toxicity (DLT) | for about 4 weeks | According to principle of Dose Limited Toxicity (DLT) assessment by National Cancer Institute Common Terminonlgy Criteria for Adverse Events (NCI-CTCAE, V4.0), DLT is evaluated above grade 3 as adverse event. |
Countries
South Korea
Outcome results
None listed