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NCT04066335 Clinical Trial

Study to Evaluate the Safety of Nanoxel M Inj.

Breast Cancer Clinical Trial

Official title:
An Observational Study to Evaluate the Safety of Nanoxel M (Docetaxel-PM) Inj.

Clinical Trial Details — Status: Recruiting

Administrative data
NCT number NCT04066335
Other study ID # DPM401
Secondary ID
Status Recruiting
Phase
First received
Last updated
Start date September 18, 2019
Est. completion date August 2024

Study information
Verified date August 2019
Source Samyang Biopharmaceuticals Corporation
Contact n/a
Is FDA regulated No
Health authority
Study type Observational

Clinical Trial Summary

Study to evaluate the safety of Nanoxel M inj. administration in patients.

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.

Recruitment information / eligibility
Status Recruiting
Enrollment 1498
Est. completion date August 2024
Est. primary completion date August 2024
Accepts healthy volunteers No
Gender All
Age group 18 Years and older
Eligibility Inclusion Criteria:

1. Adults =18 years old

2. Patients who have signed written consent form prior to participating in the clinical trial

3. Patients who are assessed as adequate to administer Nanoxel M injection.

Exclusion Criteria:

1) Patients who have shown severe hypersensitivity to Docetaxel and concomitant drugs

Study Design

Related Conditions & MeSH terms

Locations
Country Name City State
Korea, Republic of Samyang Biopharmaceuticals Seoul

Sponsors (1)
Lead Sponsor Collaborator
Samyang Biopharmaceuticals Corporation

Country where clinical trial is conducted

Korea, Republic of, 

Outcome
Type Measure Description Time frame Safety issue
Primary Safety of Nanoxel M inj. The incidence of Treatment-Emergent Adverse Event through study completion, an average of 6cycles(each cycle is 3weeks)
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