Breast CancerNCT04066335
Study to Evaluate the Safety of Nanoxel M Inj.
An observational study of Breast Cancer and Non-small Cell Lung Cancer, run by Samyang Biopharmaceuticals Corporation at 1 site in South Korea.
Trial summary
Study to evaluate the safety of Nanoxel M inj. administration in patients. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Breast Cancer, Non-small Cell Lung Cancer, Prostate Cancer
- How many people
- 1,498 participants
- Where
- 1 siteSouth Korea
- Study dates
- 18 Sep 2019to Aug 2024
- Phase
- Observational
- 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 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Patients who are assessed as adequate to administer Nanoxel M inj.
Who may be able to join
- Adults ≥18 years old
- Patients who have signed written consent form prior to participating in the clinical trial
- Patients who are assessed as adequate to administer Nanoxel M injection.
Who cannot join
- 1) Patients who have shown severe hypersensitivity to Docetaxel and concomitant drugs
Trial locations and contacts
1 site in 1 country.
South Korea1 site, 1 recruiting
- Recruiting
Samyang Biopharmaceuticals
Seoul
Mi-ryung Jin, 82-2-2157-9841, miryung.jin@samyang.com
About this study
Official title: An Observational Study to Evaluate the Safety of Nanoxel M (Docetaxel-PM) Inj.
Study to evaluate the safety of Nanoxel M inj. administration in patients.
Read the detailed description
This is a multi-center, prospective observational study to observe the incidence of adverse events under actual clinical settings to test the safety of Nanoxel-M inj. administration in patients with breast cancer, non-small cell lung cancer, prostate cancer, ovarian cancer, head \& neck cancer, gastric cancer or esophageal cancer.
- Conditions
- Breast Cancer, Non-small Cell Lung Cancer, Prostate Cancer, Ovarian Cancer, Head and Neck Cancer, Gastric Cancer
- Keywords
- Observational Study, Safety, Nanoxel M, Docetaxel
- Medical subject headings
- Breast Neoplasms, Carcinoma, Non-Small-Cell Lung, Prostatic Neoplasms, Ovarian Neoplasms, Head and Neck Neoplasms, Stomach Neoplasms, Esophageal Neoplasms
What is being measured
The primary outcome is the main question the study is designed to answer.
Safety of Nanoxel M inj.
The incidence of Treatment-Emergent Adverse Event
Measured: through study completion, an average of 6cycles(each cycle is 3weeks)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 Aug 2019
- Study start18 Sep 2019
- Primary completionAug 2024 (estimated)
- Study completionAug 2024 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for 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
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 1,498 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Samyang Biopharmaceuticals Corporation
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04066335
- Sponsor's protocol ID
- DPM401
- Status last verified
- Aug 2019
- First submitted
- 14 Aug 2019
- Last updated
- 18 Dec 2019
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 18 Dec 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- An Observational Study to Evaluate the Safety of Nanoxel M (Docetaxel-PM) Inj.
- ClinicalTrials.gov ID
- NCT04066335
- Acronym / sponsor ID
- DPM401
- Conditions
- Breast Cancer, Non-small Cell Lung Cancer, Prostate Cancer, Ovarian Cancer, Head and Neck Cancer, Gastric Cancer
- Keywords
- Observational Study, Safety, Nanoxel M, Docetaxel
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 1,498 participants (estimated)
- Lead sponsor
- Samyang Biopharmaceuticals CorporationIndustry (pharma, biotech, devices)
- Study start
- 18 Sep 2019 (actual)
- Primary completion
- Aug 2024 (estimated)
- Study completion
- Aug 2024 (estimated)
- First posted
- 26 Aug 2019 (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.
Study to evaluate the safety of Nanoxel M inj. administration in patients.
Detailed description
This is a multi-center, prospective observational study to observe the incidence of adverse events under actual clinical settings to test the safety of Nanoxel-M inj. administration in patients with breast cancer, non-small cell lung cancer, prostate cancer, ovarian cancer, head \& neck cancer, gastric cancer or esophageal cancer.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Patients who are assessed as adequate to administer Nanoxel M inj.
Key inclusion criteria (3 listed)
- Adults ≥18 years old
- Patients who have signed written consent form prior to participating in the clinical trial
- Patients who are assessed as adequate to administer Nanoxel M injection.
Key exclusion criteria (1 listed)
- 1) Patients who have shown severe hypersensitivity to Docetaxel and concomitant drugs
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Safety of Nanoxel M inj.
Time frame: through study completion, an average of 6cycles(each cycle is 3weeks)
The incidence of Treatment-Emergent Adverse Event
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 18 Dec 2019.
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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.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Breast Cancer and Non-small Cell Lung Cancer, run by Samyang Biopharmaceuticals Corporation 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 3 inclusion and 1 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 18 Dec 2019. 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.
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?
Each site lists its own contact: choose the nearest one under Trial locations. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Safety of Nanoxel M inj. (time frame: through study completion, an average of 6cycles(each cycle is 3weeks)). 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 18 Dec 2019.