Clinical Study of Decitabine and Paclitaxel Combination Therapy

Dong Wha Pharmaceutical

Status and phase: Unknown; Phase 1

Conditions: Advanced Breast Cancer

Treatments: Drug: Paclitaxel; Drug: Decitabine

Study type: Interventional

Funder types: Industry

Identifiers

NCT03282825

DW1018-I-1

Details and patient eligibility

About

Phase Ib clinical study of Decitabine and Paclitaxel combination therapy

Full 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

Enrollment: 18 estimated patients

Sex: Female

Ages: 19+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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18 participants in 1 patient group

Decitabine

Experimental group

Description:

A standard 3+3 trial design will be used for Decitabine dose escalation cohorts. The number of cohorts is three. The subjects will be administered Decitabine on every seven days in a 28day cycle and Decitabine is sequential administered with Paclitaxel. Cohort 1: Decitabine 15mg/m2, Cohort 2: Decitabine 20mg/m2, Cohort 3: Decitabine 25mg/m2

Treatment:

Drug: Decitabine

Drug: Paclitaxel