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
Sponsored by
About this trial
This is an interventional treatment trial for Advanced Breast Cancer
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
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
No
Studies a U.S. FDA-regulated Device Product
No
Product Manufactured in and Exported from the U.S.
No
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
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
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
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.
Primary Outcome Measure Information:
Title
Maximum Tolerant Dose (MTD) and Dose Limiting Toxicity (DLT)
Description
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.
Time Frame
for about 4 weeks
10. Eligibility
Sex
Female
Minimum Age & Unit of Time
19 Years
Accepts Healthy Volunteers
No
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
No
Learn more about this trial
Clinical Study of Decitabine and Paclitaxel Combination Therapy
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