Advanced Breast CancerPhase 1NCT03282825
Clinical Study of Decitabine and Paclitaxel Combination Therapy
A Phase 1 study testing Decitabine and Paclitaxel in people with Advanced Breast Cancer, run by Dong Wha Pharmaceutical Co. Ltd. at 1 site in South Korea.
Trial summary
Phase Ib clinical study of Decitabine and Paclitaxel combination therapy Read more about this study
- Who is it for?
- Ages 19 years and older, women only
- Conditions the study is for
- Advanced Breast Cancer
- What is being tested?
- Decitabine and Paclitaxel
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 18 participants
- Where
- 1 siteSouth Korea
- Study dates
- 28 Mar 2017to May 2018
- Phase
- Phase 1
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 19 years and older
- Women only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
Show all 19Show fewer
- 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
Trial locations and contacts
1 site in 1 country.
South Korea1 site
Yonsei University Health System, Severance Hospital
Seoul, 03722
About this study
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
Phase Ib clinical study of Decitabine and Paclitaxel combination therapy
Read the 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
- Being tested
- Decitabine, Paclitaxel
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
DecitabineDrug
Also called DW1018
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.
PaclitaxelDrug
Also called combination therapy
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.
| Study group | Role | What they receive |
|---|---|---|
| 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 Receives: Drug: Decitabine; Drug: Paclitaxel |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: for about 4 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 Sep 2017
- Study start28 Mar 2017
- Primary completionFeb 2018 (estimated)
- Study completionMay 2018 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Advanced Breast CancerStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 1
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 18 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Dong Wha Pharmaceutical Co. Ltd.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Joo Hyuk Sohn, MD, PhD, Principal investigator, Yonsei University Health System, Severance Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03282825
- Sponsor's protocol ID
- DW1018-I-1
- Status last verified
- Jan 2018
- First submitted
- 8 Sep 2017
- Last updated
- 23 Jan 2018
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 23 Jan 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT03282825
- Acronym / sponsor ID
- DW1018-I-1
- Conditions
- Advanced Breast Cancer
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 18 participants (estimated)
- Lead sponsor
- Dong Wha Pharmaceutical Co. Ltd.Industry (pharma, biotech, devices)
- Study start
- 28 Mar 2017 (actual)
- Primary completion
- Feb 2018 (estimated)
- Study completion
- May 2018 (estimated)
- First posted
- 14 Sep 2017 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Decitabine | Experimental | Drug: Decitabine, Drug: PaclitaxelA 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 |
Who may qualify
- Ages
- 19 years and older
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (8 listed)
- 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
Key exclusion criteria (19 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| DecitabineAlso: DW1018The 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. | Drug | Decitabine |
| PaclitaxelAlso: combination therapyThe 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. | Drug | Decitabine |
Primary outcome
Maximum Tolerant Dose (MTD) and Dose Limiting Toxicity (DLT)
Time frame: for about 4 weeks
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.
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 23 Jan 2018.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Joo Hyuk Sohn, MD, PhD principal investigator
Yonsei University Health System, Severance Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing Decitabine and Paclitaxel in people with Advanced Breast Cancer, run by Dong Wha Pharmaceutical Co. Ltd. at 1 site in South Korea.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 8 inclusion and 19 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 23 Jan 2018. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in South Korea. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Maximum Tolerant Dose (MTD) and Dose Limiting Toxicity (DLT) (time frame: for about 4 weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 23 Jan 2018.