Clinical Study of Decitabine and Paclitaxel Combination Therapy

NCT ID: NCT03282825

Last Updated: 2018-01-23

Basic Information

• Recruitment Status: UNKNOWN
• Clinical Phase: PHASE1
• Total Enrollment: 18 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2017-03-28
• Study Completion Date: 2018-05-31

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

Conditions

Advanced Breast Cancer

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Decitabine

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

Group Type: EXPERIMENTAL

Decitabine

Intervention Type: DRUG

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.

Paclitaxel

Intervention Type: DRUG

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.

Interventions

Decitabine

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.

Intervention Type: DRUG

Paclitaxel

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.

Intervention Type: DRUG

Other Intervention Names

DW1018; combination therapy

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

• Minimum Eligible Age: 19 Years
• Eligible Sex: FEMALE
• Accepts Healthy Volunteers: No

Sponsors

Dong Wha Pharmaceutical Co. Ltd.

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Joo Hyuk Sohn, MD, PhD

Role: PRINCIPAL_INVESTIGATOR

Yonsei University Health System, Severance Hospital

Locations

Yonsei University Health System, Severance Hospital

Seoul, , South Korea

Countries

South Korea

Other Identifiers

DW1018-I-1

Identifier Type: -

Identifier Source: org_study_id