Study to Evaluate the Safety of Nanoxel M Inj.

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

Status

UNKNOWN

Phases

Unknown

Study type

Observational

Source

ClinicalTrials.gov

Registry ID

NCT04066335

Enrollment

1498

Registered

2019-08-26

Start date

2019-09-18

Completion date

2024-08-31

Last updated

2019-12-18

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Breast Cancer, Esophageal Cancer, Gastric Cancer, Head and Neck Cancer, Non-small Cell Lung Cancer, Ovarian Cancer, Prostate Cancer

Keywords

Observational Study, Safety, Nanoxel M, Docetaxel

Brief summary

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.

Interventions

None listed

Study design

Observational model

COHORT

Time perspective

PROSPECTIVE

Eligibility

Sex/Gender

ALL

Age

18 Years to No maximum

Healthy volunteers

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

Design outcomes

Primary

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

Countries

South Korea

Outcome results