Overview

Clinical Study of Decitabine and Paclitaxel Combination Therapy

Status:
Unknown status

Trial end date:
2018-05-01

Target enrollment:
0

Participant gender:
Female

Summary

Phase Ib clinical study of Decitabine and Paclitaxel combination therapy

Phase:

Phase 1

Accepts Healthy Volunteers?

Details

Lead Sponsor:

Dong Wha Pharmaceutical Co. Ltd.

Treatments:

Albumin-Bound Paclitaxel
Azacitidine
Decitabine
Paclitaxel

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