NCT03282825

Brief Summary

Phase Ib clinical study of Decitabine and Paclitaxel combination therapy

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
18

participants targeted

Target at P25-P50 for phase_1

Timeline
Completed

Started Mar 2017

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

March 28, 2017

Completed
5 months until next milestone

First Submitted

Initial submission to the registry

September 8, 2017

Completed
6 days until next milestone

First Posted

Study publicly available on registry

September 14, 2017

Completed
5 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

February 1, 2018

Completed
3 months until next milestone

Study Completion

Last participant's last visit for all outcomes

May 1, 2018

Completed
Last Updated

January 23, 2018

Status Verified

January 1, 2018

Enrollment Period

10 months

First QC Date

September 8, 2017

Last Update Submit

January 21, 2018

Conditions

Advanced Breast Cancer

Outcome Measures

Primary Outcomes (1)

  • 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.

    for about 4 weeks

Study Arms (1)

Decitabine

EXPERIMENTAL

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

Drug: DecitabineDrug: Paclitaxel

Interventions

DecitabineDRUG

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.

Also known as: DW1018
Decitabine
PaclitaxelDRUG

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.

Also known as: combination therapy
Decitabine

Eligibility Criteria

Age19 Years+
Sexfemale
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • 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
  • +4 more criteria

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Yonsei University Health System, Severance Hospital

Seoul, 03722, South Korea

Location

MeSH Terms

Interventions

DecitabinePaclitaxelCombined Modality Therapy

Intervention Hierarchy (Ancestors)

AzacitidineAza CompoundsOrganic ChemicalsCytidinePyrimidine NucleosidesPyrimidinesHeterocyclic Compounds, 1-RingHeterocyclic CompoundsNucleosidesNucleic Acids, Nucleotides, and NucleosidesRibonucleosidesTaxoidsCyclodecanesCycloparaffinsHydrocarbons, AlicyclicHydrocarbons, CyclicHydrocarbonsDiterpenesTerpenesTherapeutics

Study Officials

  • Joo Hyuk Sohn, MD, PhD

    Yonsei University Health System, Severance Hospital

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 1
Allocation
NA
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

September 8, 2017

First Posted

September 14, 2017

Study Start

March 28, 2017

Primary Completion

February 1, 2018

Study Completion

May 1, 2018

Last Updated

January 23, 2018

Record last verified: 2018-01

Data Sharing

IPD Sharing
Will not share

Locations

KR(1)