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Clinical Study of Decitabine and Paclitaxel Combination Therapy

Primary Purpose

Advanced Breast Cancer

Status

Unknown status

Phase

Phase 1

Locations

Korea, Republic of

Study Type

Interventional

Intervention

Decitabine

Paclitaxel

About this trial

This is an interventional treatment trial for Advanced Breast Cancer

Eligibility Criteria

19 Years - undefined (Adult, Older Adult)FemaleDoes not accept healthy volunteers

Inclusion Criteria:

age ≥ 19 years as female
be unable to operate for therapy with HER2 negative breast adenocarcinoma and metastatic breast cancer, one or more chemotherapy
according to RECIST ver.1.1, one or more evaluable lesion
Eastern cooperative oncology group(ECOG) performance score is o or 1
lesion for core biopsy
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
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
Given signed and dated written informed consent form

Exclusion Criteria:

Symptomatic metastasis and Leptomeningeal metastasis
Injection of paclitaxel for metastatic breast cancer within 6 months
HER2, Positive Breast adenocarcinoma
cancertherapy for whole body within 3 weeks
radiotherapy for metastatic region within 4 weeks
major surgery, open biopsy and trauma within 4 weeks
less than 4 weeks post major surgery
treatment with consistently systemic corticosteroid or immunosuppressive drug
more than 2 grade for peripheral neuropathy
Congenital ling QT syndrome or QTc interval > 480 milisecond
occur myocardial infartion within 6 months
unstable angina pectoris
HIV(+) or AIDS
HBsAg(+) or HCV(+)
treatment bisphosphonate for hypercalcemia
except metastatic and locally advanced breast cancer, personal history with malignancy within 5 years
hypersensitivity reaction with paclitaxel or Cremophor EL formulation
Pregnant or breast feeding
be unable or unwilling to abide by the study protocol or to cooperate fully with the investigator or designee

Sites / Locations

Yonsei University Health System, Severance Hospital

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Decitabine

Arm 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

Outcomes

Primary Outcome Measures

Maximum Tolerant Dose (MTD) and Dose Limiting Toxicity (DLT)

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.

Secondary Outcome Measures

Full Information

NCT ID

NCT03282825

First Posted

September 8, 2017

Last Updated

January 21, 2018

Sponsor

Dong Wha Pharmaceutical Co. Ltd.

1. Study Identification

Unique Protocol Identification Number

NCT03282825

Brief Title

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

2. Study Status

Record Verification Date

January 2018

Overall Recruitment Status

Unknown status

Study Start Date

March 28, 2017 (Actual)

Primary Completion Date

February 2018 (Anticipated)

Study Completion Date

May 2018 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor

Name of the Sponsor

Dong Wha Pharmaceutical Co. Ltd.

4. Oversight

Studies a U.S. FDA-regulated Drug Product

Studies a U.S. FDA-regulated Device Product

Product Manufactured in and Exported from the U.S.

5. Study Description

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

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Advanced Breast Cancer

7. Study Design

Primary Purpose

Treatment

Study Phase

Phase 1

Interventional Study Model

Single Group Assignment

Masking

None (Open Label)

Allocation

N/A

Enrollment

18 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title

Decitabine

Arm Type

Experimental

Arm Description

Intervention Type

Drug

Intervention Name(s)

Decitabine

Other Intervention Name(s)

DW1018

Intervention Description

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

Intervention Name(s)

Paclitaxel

Other Intervention Name(s)

combination therapy

Intervention Description

Primary Outcome Measure Information:

Title

Maximum Tolerant Dose (MTD) and Dose Limiting Toxicity (DLT)

Description

Time Frame

for about 4 weeks

10. Eligibility

Sex

Female

Minimum Age & Unit of Time

19 Years

Accepts Healthy Volunteers

Eligibility Criteria

Inclusion Criteria: age ≥ 19 years as female be unable to operate for therapy with HER2 negative breast adenocarcinoma and metastatic breast cancer, one or more chemotherapy according to RECIST ver.1.1, one or more evaluable lesion Eastern cooperative oncology group(ECOG) performance score is o or 1 lesion for core biopsy 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 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 Given signed and dated written informed consent form Exclusion Criteria: Symptomatic metastasis and Leptomeningeal metastasis Injection of paclitaxel for metastatic breast cancer within 6 months HER2, Positive Breast adenocarcinoma cancertherapy for whole body within 3 weeks radiotherapy for metastatic region within 4 weeks major surgery, open biopsy and trauma within 4 weeks less than 4 weeks post major surgery treatment with consistently systemic corticosteroid or immunosuppressive drug more than 2 grade for peripheral neuropathy Congenital ling QT syndrome or QTc interval > 480 milisecond occur myocardial infartion within 6 months unstable angina pectoris HIV(+) or AIDS HBsAg(+) or HCV(+) treatment bisphosphonate for hypercalcemia except metastatic and locally advanced breast cancer, personal history with malignancy within 5 years hypersensitivity reaction with paclitaxel or Cremophor EL formulation Pregnant or breast feeding be unable or unwilling to abide by the study protocol or to cooperate fully with the investigator or designee

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Joo Hyuk Sohn, MD, PhD

Organizational Affiliation

Yonsei University Health System, Severance Hospital

Official's Role

Principal Investigator

Facility Information:

Facility Name

Yonsei University Health System, Severance Hospital

City

Seoul

ZIP/Postal Code

03722

Country

Korea, Republic of

12. IPD Sharing Statement

Plan to Share IPD

Learn more about this trial

Clinical Study of Decitabine and Paclitaxel Combination Therapy

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