Clinical Study of Decitabine and Paclitaxel Combination Therapy

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

Phase Ib clinical study of Decitabine and Paclitaxel combination therapy

Study Overview

• Status: Unknown
• Conditions: Advanced Breast Cancer
• Intervention / Treatment: Drug: Decitabine; Drug: Paclitaxel

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

• Study Type: Interventional
• Enrollment (Anticipated): 18
• Phase: Phase 1

Contacts and Locations

Study Locations

• Korea, Republic of
  • Seoul, Korea, Republic of, 03722
    • Yonsei University Health system, Severance Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 19 years and older (ADULT, OLDER_ADULT)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: Female

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: TREATMENT
• Allocation: NA
• Interventional Model: SINGLE_GROUP
• Masking: NONE

Number of Arms

1

Arms and Interventions

Participant Group / Arm

Intervention / Treatment

EXPERIMENTAL: 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

Drug: 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.; Other Names: DW1018; 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.; Other Names: combination therapy

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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

Collaborators and Investigators

• Sponsor: Dong Wha Pharmaceutical Co. Ltd.
• Investigators: Principal Investigator: Joo Hyuk Sohn, MD, PhD, Yonsei University Health system, Severance Hospital

Study record dates

Study Major Dates

• Study Start (ACTUAL): March 28, 2017
• Primary Completion (ANTICIPATED): February 1, 2018
• Study Completion (ANTICIPATED): May 1, 2018

Study Registration Dates

• First Submitted: September 8, 2017
• First Submitted That Met QC Criteria: September 13, 2017
• First Posted (ACTUAL): September 14, 2017

Study Record Updates

• Last Update Posted (ACTUAL): January 23, 2018
• Last Update Submitted That Met QC Criteria: January 21, 2018
• Last Verified: January 1, 2018

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Skin Diseases; Neoplasms; Neoplasms by Site; Breast Diseases; Breast Neoplasms; Molecular Mechanisms of Pharmacological Action; Enzyme Inhibitors; Antimetabolites, Antineoplastic; Antimetabolites; Antineoplastic Agents; Tubulin Modulators; Antimitotic Agents; Mitosis Modulators; Antineoplastic Agents, Phytogenic; Decitabine; Paclitaxel
• Other Study ID Numbers: DW1018-I-1

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• 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