Clinical trial NCT03282825: Clinical Study of Decitabine and Paclitaxel Combination Therapy
Official title: 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
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: PHASE1
Conditions: Advanced Breast Cancer
Lead sponsor: Dong Wha Pharmaceutical Co. Ltd.
Sponsor class: INDUSTRY
First posted: 2017-09-14
Enrollment: 18
Sex: FEMALE
Minimum age (years): 19
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

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 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

Primary outcomes:
measure: Maximum Tolerant Dose (MTD) and Dose Limiting Toxicity (DLT)
timeFrame: for about 4 weeks
Secondary outcomes:
Other outcomes:
Locations:
city: Seoul
country: Korea, Republic of
facility: Yonsei University Health System, Severance Hospital
Study officials:
affiliation: Yonsei University Health System, Severance Hospital
name: Joo Hyuk Sohn, MD, PhD
role: PRINCIPAL_INVESTIGATOR
References: